Release 4B 5 Ballot

This page is part of the FHIR Specification (v4.3.0: R4B (v5.0.0-ballot: R5 Ballot - STU see ballot notes ). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3

Researchstudy.profile.xml

Example StructureDefinition/ResearchStudy (XML)

Biomedical Research and Regulation Work Group Maturity Level : N/A Standards Status : Informative Compartments : Practitioner Not linked to any defined compartments

Raw XML ( canonical form + also see XML Format Specification )

Jump past Narrative

StructureDefinition for researchstudy

<?xml version="1.0" encoding="UTF-8"?>

<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="ResearchStudy"/> 
  <meta> 
    

    <lastUpdated value="2022-09-10T04:52:37.223+10:00"/> 
  </meta> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      
        
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            <a href="formats.html#table" title="The logical name of the element">Name</a> 
          </th> 
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           padding:0px 4px 0px 4px

          <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="formats.html#table" title="Information about the use of the element">Flags</a> 
          </th> 
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           padding:0px 4px 0px 4px

          <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="formats.html#table" title="Minimum and Maximum # of times the the element can appear in the instance">Card.</a> 
          </th> 
          <th class="hierarchy" style="width: 100px">
            <a href="formats.html#table" title="Reference to the type of the element">Type</a> 
          </th> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px

          <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="formats.html#table" title="Additional information about the element">Description &amp; Constraints</a> 
            <span style="float: right">
              <a href="formats.html#table" title="Legend for this format">
                <img alt="doco" src="help16.png" style="background-color: inherit"/> 
              </a> 
            </span> 
          </th> 
        </tr> 
        
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            ABJRU5ErkJggg== 
            ResearchStudy : A process where a researcher or organization plans and then executes a
             series of steps intended to increase the field of healthcare-related knowledge.  This
             includes studies of safety, efficacy, comparative effectiveness and other information
             about medications, devices, therapies and other interventional and investigative techniques.
              A ResearchStudy involves the gathering of information about human or animal subjects.

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            qAeSFSduL9Akj7qPF64jnALS5VTPwdgPwwJ+uog9Qcx4kRZiPKqxgAAAABJRU5ErkJggg==" style="background-color: white; background-color: inherit" title="Resource"/>  
            <span title="ResearchStudy : A scientific study of nature that sometimes includes processes

             involved in health and disease. For example, clinical trials are research studies
             that involve people. These studies may be related to new ways to screen, prevent,
             diagnose, and treat disease. They may also study certain outcomes and certain groups
             of people by looking at data collected in the past or future.">ResearchStudy</span> 

            <a name="ResearchStudy"> </a> 
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           padding:0px 4px 0px 4px
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             black; background-color: #fff5e6

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="versions.html#std-process" style="padding-left: 3px; padding-right: 3px; border: 1px grey solid; font-weight: bold;

             color: black; background-color: #fff5e6" title="Standards Status = Trial Use">TU</a> 

          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">

            <a href="domainresource.html">DomainResource</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4pxInvestigation to increase healthcare-related patient-independent knowledge

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">Investigation to increase healthcare-related patient-independent knowledge
            <br/>  
            <br/>  Elements defined in Ancestors: 
            The logical id of the resource, as used in the URL for the resource. Once assigned, this
             value never changes., 

            <a href="resource.html#Resource" title="The logical id of the resource, as used in the URL for the resource. Once assigned,
             this value never changes.">id</a> , 

            <a href="resource.html#Resource" title="The metadata about the resource. This is content that is maintained by the infrastructure.
             Changes to the content might not always be associated with version changes to the resource., 
            A reference to a set of rules that were followed when the resource was constructed, and
             which must be understood when processing the content. Often, this is a reference to an
             implementation guide that defines the special rules along with other profiles etc., 

             Changes to the content might not always be associated with version changes to the
             resource.">meta</a> , 
            <a href="resource.html#Resource" title="A reference to a set of rules that were followed when the resource was constructed,

             and which must be understood when processing the content. Often, this is a reference
             to an implementation guide that defines the special rules along with other profiles
             etc.">implicitRules</a> , 

            <a href="resource.html#Resource" title="The base language in which the resource is written.">language</a> , 
            A human-readable narrative that contains a summary of the resource and can be used to
             represent the content of the resource to a human. The narrative need not encode all the
             structured data, but is required to contain sufficient detail to make it &quot;clinically
             safe&quot; for a human to just read the narrative. Resource definitions may define what
             content should be represented in the narrative to ensure clinical safety., 
            These resources do not have an independent existence apart from the resource that contains
             them - they cannot be identified independently, and nor can they have their own independent
             transaction scope., 

            <a href="domainresource.html#DomainResource" title="A human-readable narrative that contains a summary of the resource and can be used
             to represent the content of the resource to a human. The narrative need not encode
             all the structured data, but is required to contain sufficient detail to make it
             &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions
             may define what content should be represented in the narrative to ensure clinical
             safety.">text</a> , 
            <a href="domainresource.html#DomainResource" title="These resources do not have an independent existence apart from the resource that

             contains them - they cannot be identified independently, nor can they have their
             own independent transaction scope. This is allowed to be a Parameters resource
             if and only if it is referenced by a resource that provides context/meaning.">contained</a> , 

            <a href="domainresource.html#DomainResource" title="May be used to represent additional information that is not part of the basic definition
             of the resource. To make the use of extensions safe and manageable, there is a strict
             set of governance  applied to the definition and use of extensions. Though any implementer
             can define an extension, there is a set of requirements that SHALL be met as part of the
             definition of the extension., 

             of the resource. To make the use of extensions safe and manageable, there is a
             strict set of governance  applied to the definition and use of extensions. Though
             any implementer can define an extension, there is a set of requirements that SHALL
             be met as part of the definition of the extension.">extension</a> , 

            <a href="domainresource.html#DomainResource" title="May be used to represent additional information that is not part of the basic definition
             of the resource and that modifies the understanding of the element that contains it and/or
             the understanding of the containing element's descendants. Usually modifier elements provide
             negation or qualification. To make the use of extensions safe and manageable, there is
             a strict set of governance applied to the definition and use of extensions. Though any
             implementer is allowed to define an extension, there is a set of requirements that SHALL
             be met as part of the definition of the extension. Applications processing a resource
             are required to check for modifier extensions.

             of the resource and that modifies the understanding of the element that contains
             it and/or the understanding of the containing element's descendants. Usually modifier
             elements provide negation or qualification. To make the use of extensions safe
             and manageable, there is a strict set of governance applied to the definition and
             use of extensions. Though any implementer is allowed to define an extension, there
             is a set of requirements that SHALL be met as part of the definition of the extension.
             Applications processing a resource are required to check for modifier extensions.


Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource
             (including cannot change the meaning of modifierExtension itself).

Modifier extensions SHALL NOT change the meaning of any elements on Resource or
             DomainResource (including cannot change the meaning of modifierExtension itself).">modifierExtension</a> 

          </td> 
        </tr> 

        
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            uYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type"/>  
            <span title="ResearchStudy.url : Canonical identifier for this study resource, represented as

             a globally unique URI.">url</span> 
            <a name="ResearchStudy.url"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="datatypes.html#uri">uri</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">Canonical identifier for this study resource
            <br/>  
          </td> 
        </tr> 


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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
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          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="datatypes.html#Identifier">Identifier</a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <br/>  
            <br/>  
          </td> 
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            <span title="ResearchStudy.version : The business version for the study record.">version</span> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="datatypes.html#string">string</a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

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            <span title="ResearchStudy.name : Name for this study (computer friendly).">name</span> 
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            <a href="datatypes.html#string">string</a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
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           padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="datatypes.html#string">string</a> 
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           padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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          </td> 
        </tr> 

        
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            ResearchStudy.protocol : The set of steps expected to be performed as part of the execution
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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            <a href="types.html#BackBoneElement">BackboneElement</a> 
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           solid; padding:0px 4px 0px 4px
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <br/>  
            <br/>  
          </td> 
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            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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             | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
            <br/>  
            <a href="valueset-title-type.html">TitleType</a>  (
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             set if any of the codes within the value set can apply to the concept being communicated.
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            <a href="datatypes.html#string">string</a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <span title="ResearchStudy.protocol : The set of steps expected to be performed as part of the

             execution of the study.">protocol</span> 
            <a name="ResearchStudy.protocol"> </a> 
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="references.html#Reference">Reference</a> (
            <a href="plandefinition.html">PlanDefinition</a> )
          </td> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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            <br/>  
            <br/>  
          </td> 
        </tr> 

        
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            ResearchStudy.partOf : A larger research study of which this particular study is a component
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
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          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
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            <a href="references.html#Reference">Reference</a> (
            <a href="researchstudy.html">ResearchStudy</a> )
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            <br/>  
            <br/>  
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            <a name="ResearchStudy.relatedArtifact"> </a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="metadatatypes.html#RelatedArtifact">RelatedArtifact</a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">References and dependencies
            <br/>  
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

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            <span title="ResearchStudy.date : The date (and optionally time) when the ResearchStudy Resource

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             change if the status code changes. In addition, it should change when the substantive
             content of the ResearchStudy Resource changes.">date</span> 
            <a name="ResearchStudy.date"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#dateTime">dateTime</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">Date the resource last changed
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

         #F7F7F7">
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw

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            <span title="ResearchStudy.status : The publication state of the resource (not of the study).">status</span> 
            <a name="ResearchStudy.status"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">

            <a href="conformance-rules.html#isModifier" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is a modifier element">?!</a> 
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">

            <a href="datatypes.html#code">code</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4pxactive | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervent
            ion | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-acc
            rual-and-intervention | withdrawn

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">draft | active | retired | unknown
            <br/>  
            <a href="valueset-publication-status.html">PublicationStatus</a>  (
            <a href="terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value

             set.">Required</a> )

            <br/>  
             (
            )

          </td> 
        </tr> 

        
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
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            ResearchStudy.primaryPurposeType : The type of study based upon the intent of the study's
             activities. A classification of the intent of the study.

        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw

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            <span title="ResearchStudy.primaryPurposeType : The type of study based upon the intent of the

             study activities. A classification of the intent of the study.">primaryPurposeType</span> 

            <a name="ResearchStudy.primaryPurposeType"> </a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">

            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">

            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4pxtreatment | prevention | diagnostic | supportive-care | screening | health-services-research

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">treatment | prevention | diagnostic | supportive-care | screening | health-services-research

             | basic-science | device-feasibility
            <br/>  
            <a href="valueset-research-study-prim-purp-type.html">ResearchStudyPrimaryPurposeType</a>  (
            To be conformant, the concept in this element SHALL be from the specified value set if
             any of the codes within the value set can apply to the concept being communicated.  If
             the value set does not cover the concept (based on human review), alternate codings (or,
             data type allowing, text) may be included instead.)

            <a href="terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value
             set if any of the codes within the value set can apply to the concept being communicated.
              If the value set does not cover the concept (based on human review), alternate
             codings (or, data type allowing, text) may be included instead.">Extensible</a> )
            <br/>  
          </td> 
        </tr> 

        
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
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           solid; padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4pxn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3

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             | phase-4
            <br/>  
            <a href="valueset-research-study-phase.html">ResearchStudyPhase</a>  (
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             value set merely provides examples of the types of concepts intended to be included.)

            <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
             set.  The value set merely provides examples of the types of concepts intended
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            <br/>  
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">

            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
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          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4pxClassifications for the study
            ResearchStudyCategory (
            Instances are not expected or even encouraged to draw from the specified value set.  The
             value set merely provides examples of the types of concepts intended to be included.)

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <br/>  
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            <a href="terminologies.html#preferred" title="Instances are encouraged to draw from the specified codes for interoperability

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            <br/>  
            <br/>  
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            ResearchStudy.focus : The medication(s), food(s), therapy(ies), device(s) or other concerns
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            <span title="ResearchStudy.focus : The medication(s), food(s), therapy(ies), device(s) or other

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            <a name="ResearchStudy.focus"> </a> 
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          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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            <a href="types.html#BackBoneElement">BackboneElement</a> 
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            <br/>  
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            <span title="ResearchStudy.focus.productCode : Identification of product under study.  This

             may be any combination of code and/or name.">productCode</span> 
            <a name="ResearchStudy.focus.productCode"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4pxDrugs, devices, etc. under study

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">Identification of product under study

            <br/>  ResearchStudyFocus (
            Instances are not expected or even encouraged to draw from the specified value set.  The
             value set merely provides examples of the types of concepts intended to be included.)

            <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
             set.  The value set merely provides examples of the types of concepts intended
             to be included.">Example</a> )

            <br/>  
          </td> 
        </tr> 

        
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            ResearchStudy.condition : The condition that is the focus of the study.  For example,
             In a study to examine risk factors for Lupus, might have as an inclusion criterion &quot;healthy
             volunteer&quot;, but the target condition code would be a Lupus SNOMED code.
            
          
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px
            

        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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            <span title="ResearchStudy.focus.focusType : Indicates whether the focus is a medication, a

             device, a procedure, a specific factor or some other intervention or characteristic.">focusType</span> 
            <a name="ResearchStudy.focus.focusType"> </a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">

            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4pxCondition being studied

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">medication | device | intervention | factor
            <br/>  
            <a href="valueset-research-study-focus-type.html">ResearchStudyFocusType</a>  (
            <a href="terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value

             set if any of the codes within the value set can apply to the concept being communicated.
              If the value set does not cover the concept (based on human review), alternate
             codings (or, data type allowing, text) may be included instead.">Extensible</a> )

            <br/>  
             (
            Instances are not expected or even encouraged to draw from the specified value set.  The
             value set merely provides examples of the types of concepts intended to be included.)

            <br/>  
          </td> 
        </tr> 

        
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            ResearchStudy.contact : Contact details to assist a user in learning more about or engaging
             with the study.
            
          
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px
            

        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
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            YAAAAB3RJTUUH3wYeFzMPbYccAgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAMElEQVQ4y
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw

            YAAAAB3RJTUUH3wYeFzME+lXFigAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y
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            YAAAARklEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyj
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            <span title="ResearchStudy.focus.factor : A factor corresponds to an independent variable manipulated

             by the experimentalist with the intention to affect biological systems in a way
             that can be measured by an assay.">factor</span> 
            <a name="ResearchStudy.focus.factor"> </a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            

            <a href="datatypes.html#markdown">markdown</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4pxContact details for the study

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <br/>  
          </td> 
        </tr> 

        
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           padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px
            

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4pxReferences and dependencies

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">Condition being studied
            <br/>  
            <a href="valueset-condition-code.html">Condition/Problem/Diagnosis Codes</a>  (
            <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value

             set.  The value set merely provides examples of the types of concepts intended
             to be included.">Example</a> )
            <br/>  
            <br/>  
          </td> 
        </tr> 

        
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            <span title="ResearchStudy.keyword : Key terms to aid in searching for or filtering the study.">keyword</span> 
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
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          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
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            <br/>  ResearchStudyKeyword (
            Instances are not expected or even encouraged to draw from the specified value set.  The
             value set merely provides examples of the types of concepts intended to be included.)

            <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
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            <br/>  
            <br/>  
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            ResearchStudy.location : Indicates a country, state or other region where the study is
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            <span title="ResearchStudy.region : A country, state or other area where the study is taking

             place rather than its precise geographic location or address.">region</span> 
            <a name="ResearchStudy.region"> </a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">

            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">

            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4pxGeographic region(s) for study

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">Geographic area for the study

            <br/>  
            <a href="valueset-jurisdiction.html">Jurisdiction</a>  (
            To be conformant, the concept in this element SHALL be from the specified value set if
             any of the codes within the value set can apply to the concept being communicated.  If
             the value set does not cover the concept (based on human review), alternate codings (or,
             data type allowing, text) may be included instead.)

            <a href="terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value
             set if any of the codes within the value set can apply to the concept being communicated.
              If the value set does not cover the concept (based on human review), alternate
             codings (or, data type allowing, text) may be included instead.">Extensible</a> )
            <br/>  
            <br/>  
          </td> 
        </tr> 

        
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            <span title="ResearchStudy.descriptionSummary : A brief text for explaining the study.">descriptionSummary</span> 
            <a name="ResearchStudy.descriptionSummary"> </a> 
          </td> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px"/> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="datatypes.html#markdown">markdown</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">Brief text explaining the study
            <br/>  
          </td> 
        </tr> 

        
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            ResearchStudy.enrollment : Reference to a Group that defines the criteria for and quantity
             of subjects participating in the study.  E.g. &quot; 200 female Europeans between the
             ages of 20 and 45 with early onset diabetes&quot;.
            
          
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
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        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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            <span title="ResearchStudy.description : A detailed and human-readable narrative of the study.

             E.g., study abstract.">description</span> 
            <a name="ResearchStudy.description"> </a> 
          </td> 
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           padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
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            (
            )

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="datatypes.html#markdown">markdown</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4pxInclusion &amp; exclusion criteria

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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            <br/>  
          </td> 
        </tr> 

        
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            <span title="ResearchStudy.period : Identifies the start date and the expected (or actual, depending
             on status) end date for the study.">period</span> 
            <a name="ResearchStudy.period"> </a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..1</td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="datatypes.html#Period">Period</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">When the study began and ended
            <br/>  
          </td> 
        </tr> 

        
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            ResearchStudy.sponsor : An organization that initiates the investigation and is legally
             responsible for the study.
            

        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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            <span title="ResearchStudy.site : A facility in which study activities are conducted.">site</span> 
            <a name="ResearchStudy.site"> </a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="references.html#Reference">Reference</a> (
            <a href="location.html">Location</a>  | 
            <a href="researchstudy.html">ResearchStudy</a>  | 
            <a href="organization.html">Organization</a> )
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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            <br/>  
            <br/>  
          </td> 
        </tr> 

        
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            ResearchStudy.principalInvestigator : A researcher in a study who oversees multiple aspects
             of the study, such as concept development, protocol writing, protocol submission for IRB
             approval, participant recruitment, informed consent, data collection, analysis, interpretation
             and presentation.
            

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            <span title="ResearchStudy.note : Comments made about the study by the performer, subject or

             other participants.">note</span> 
            <a name="ResearchStudy.note"> </a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            

            <a href="datatypes.html#Annotation">Annotation</a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">Comments made about the study
            <br/>  
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

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            <span title="ResearchStudy.classifier : Additional grouping mechanism or categorization of a

             research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph
             23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not
             use the classifier element to support existing semantics that are already supported
             thru explicit elements in the resource.">classifier</span> 
            <a name="ResearchStudy.classifier"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">Classification for the study
            <br/>  
            <a href="valueset-research-study-classifiers.html">Research Study Classifiers</a>  (
            <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value

             set.  The value set merely provides examples of the types of concepts intended
             to be included.">Example</a> )
            <br/>  
            <br/>  
          </td> 
        </tr> 


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            <span title="ResearchStudy.associatedParty : Sponsors, collaborators, and other parties.">associatedParty</span> 
            <a name="ResearchStudy.associatedParty"> </a> 
          </td> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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            <a href="types.html#BackBoneElement">BackboneElement</a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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            <br/>  
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

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            <a name="ResearchStudy.associatedParty.name"> </a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="datatypes.html#string">string</a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <br/>  
          </td> 
        </tr> 


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            <span title="ResearchStudy.associatedParty.role : Type of association.">role</span> 
            <a name="ResearchStudy.associatedParty.role"> </a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator
             | funding-source | general-contact | recruitment-contact | sub-investigator | study-director
             | study-chair
            <br/>  
            <a href="valueset-research-study-party-role.html">Research Study Party Role</a>  (
            <a href="terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value

             set if any of the codes within the value set can apply to the concept being communicated.
              If the value set does not cover the concept (based on human review), alternate
             codings (or, data type allowing, text) may be included instead.">Extensible</a> )
            <br/>  
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            <span title="ResearchStudy.associatedParty.period : Identifies the start date and the end date

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            <a name="ResearchStudy.associatedParty.period"> </a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="datatypes.html#Period">Period</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">When active in the role
            <br/>  
            <br/>  
          </td> 
        </tr> 


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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <br/>  
            <a href="valueset-research-study-party-org-type.html">Research Study Party Organization Type</a>  (
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             set.  The value set merely provides examples of the types of concepts intended
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            <br/>  
            <br/>  
          </td> 
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            <span title="ResearchStudy.associatedParty.party : Individual or organization associated with

             study (use practitionerRole to specify their organisation).">party</span> 
            <a name="ResearchStudy.associatedParty.party"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="references.html#Reference">Reference</a> (
            <a href="practitioner.html">Practitioner</a>  | 
            )

            <a href="practitionerrole.html">PractitionerRole</a>  | 
            <a href="organization.html">Organization</a> )
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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             their organisation)
            <br/>  
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px

        </tr> 

        
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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            <a href="types.html#BackBoneElement">BackboneElement</a> 
          </td> 
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           padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px
            (
            )

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">Status of study with time for that status
            <br/>  
            <br/>  
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4pxFacility where study activities are conducted

        </tr> 

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <span title="ResearchStudy.progressStatus.state : Label for status or state (e.g. recruitment

             status).">state</span> 
            <a name="ResearchStudy.progressStatus.state"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">Label for status or state (e.g. recruitment status)
            <br/>  
            <a href="valueset-research-study-status.html">ResearchStudyStatus</a>  (
            <a href="terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value

             set if any of the codes within the value set can apply to the concept being communicated.
              If the value set does not cover the concept (based on human review), alternate
             codings (or, data type allowing, text) may be included instead.">Extensible</a> )

            <br/>  
          </td> 
        </tr> 

        
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            ResearchStudy.reasonStopped : A description and/or code explaining the premature termination
             of the study.
            

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            <span title="ResearchStudy.progressStatus.actual : An indication of whether or not the date

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             a known date. A value of false indicates an estimated date.">actual</span> 
            <a name="ResearchStudy.progressStatus.actual"> </a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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            <a href="datatypes.html#boolean">boolean</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">Actual if true else anticipated
            <br/>  
          </td> 
        </tr> 


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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
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            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
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          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4pxaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-close
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <br/>  
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            <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
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            <br/>  
          </td> 
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
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            ResearchStudy.arm : Describes an expected sequence of events for one of the participants
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#unsignedInt">unsignedInt</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">Estimated total number of participants to be enrolled
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
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            <span title="ResearchStudy.recruitment.actualNumber : Actual total number of participants enrolled

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            <a name="ResearchStudy.recruitment.actualNumber"> </a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#unsignedInt">unsignedInt</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">Actual total number of participants enrolled in study
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

         white">
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           solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw

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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw

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            <span title="ResearchStudy.recruitment.eligibility : Inclusion and exclusion criteria.">eligibility</span> 
            <a name="ResearchStudy.recruitment.eligibility"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">
            <a href="references.html#Reference">Reference</a> (
            <a href="group.html">Group</a>  | 
            <a href="evidencevariable.html">EvidenceVariable</a> )
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">Inclusion and exclusion criteria
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

         #F7F7F7">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <span title="ResearchStudy.recruitment.actualGroup : Group of participants who were enrolled

             in study.">actualGroup</span> 
            <a name="ResearchStudy.recruitment.actualGroup"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="references.html#Reference">Reference</a> (
            <a href="group.html">Group</a> )
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">Group of participants who were enrolled in study
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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            <span title="ResearchStudy.comparisonGroup : Describes an expected sequence of events for one

             of the participants of a study.  E.g. Exposure to drug A, wash-out, exposure to
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            <a name="ResearchStudy.comparisonGroup"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="types.html#BackBoneElement">BackboneElement</a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <br/>  
            <br/>  
          </td> 
        </tr> 

        
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            <span title="ResearchStudy.comparisonGroup.identifier[x] : Allows the comparisonGroup for the

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            ResearchStudy.arm.type : Categorization of study arm, e.g. experimental, active comparator,
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">Categorization of study comparisonGroup
            <br/>  
            <a href="valueset-research-study-arm-type.html">ResearchStudyArmType</a>  (
            <a href="terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value

             set if any of the codes within the value set can apply to the concept being communicated.
              If the value set does not cover the concept (based on human review), alternate
             codings (or, data type allowing, text) may be included instead.">Extensible</a> )
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

         white">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
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            YAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI1
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw

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            <span title="ResearchStudy.comparisonGroup.description : A succinct description of the path

             through the study that would be followed by a subject adhering to this comparisonGroup.">description</span> 
            <a name="ResearchStudy.comparisonGroup.description"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px"/> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..1</td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            

            <a href="datatypes.html#markdown">markdown</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">Short explanation of study path
            <br/>  
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px

        </tr> 

        
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            ResearchStudy.arm.description : A succinct description of the path through the study that
             would be followed by a subject adhering to this arm.
            

        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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            <span title="ResearchStudy.comparisonGroup.intendedExposure : Interventions or exposures in

             this comparisonGroup or cohort.">intendedExposure</span> 
            <a name="ResearchStudy.comparisonGroup.intendedExposure"> </a> 
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px
            

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="references.html#Reference">Reference</a> (
            <a href="evidencevariable.html">EvidenceVariable</a> )
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">Interventions or exposures in this comparisonGroup or cohort
            <br/>  
            <br/>  
          </td> 
          vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid;
           padding:0px 4px 0px 4px

        </tr> 

        
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           solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB
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            ResearchStudy.objective : A goal that the study is aiming to achieve in terms of a scientific
             question to be answered by the analysis of data collected during the study.
            

        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         white">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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            <span title="ResearchStudy.comparisonGroup.observedGroup : Group of participants who were enrolled

             in study comparisonGroup.">observedGroup</span> 
            <a name="ResearchStudy.comparisonGroup.observedGroup"> </a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px"/> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            

            <a href="references.html#Reference">Reference</a> (
            <a href="group.html">Group</a> )
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4pxA goal for the study

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">Group of participants who were enrolled in study comparisonGroup

            <br/>  
          </td> 
        </tr> 

        
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            ResearchStudy.objective.name : Unique, human-readable label for this objective of the
             study.

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            <span title="ResearchStudy.objective : A goal that the study is aiming to achieve in terms of

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            <a name="ResearchStudy.objective"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="types.html#BackBoneElement">BackboneElement</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">A goal for the study
            <br/>  
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

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            <a name="ResearchStudy.objective.name"> </a> 
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           padding:0px 4px 0px 4px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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            <a href="datatypes.html#string">string</a> 
          </td> 
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           padding:0px 4px 0px 4px

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <br/>  
          </td> 
        </tr> 

        
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            <span title="ResearchStudy.objective.type : The kind of study objective.">type</span> 
            <a name="ResearchStudy.objective.type"> </a> 
          </td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <br/>  
            <a href="valueset-research-study-objective-type.html">ResearchStudyObjectiveType</a>  (
            <a href="terminologies.html#preferred" title="Instances are encouraged to draw from the specified codes for interoperability

             purposes but are not required to do so to be considered conformant.">Preferred</a> )
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

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            <span title="ResearchStudy.objective.description : Free text description of the objective of

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             to achieve it (see ResearchStudy.description).">description</span> 
            <a name="ResearchStudy.objective.description"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px"/> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..1</td> 
          vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0

          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#markdown">markdown</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">Description of the objective
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

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            <span title="ResearchStudy.outcomeMeasure : An outcome or planned variable to measure during

             the study.">outcomeMeasure</span> 
            <a name="ResearchStudy.outcomeMeasure"> </a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
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            <br/>  
            <a href="valueset-research-study-objective-type.html">ResearchStudyObjectiveType</a>  (
            Instances are encouraged to draw from the specified codes for interoperability purposes
             but are not required to do so to be considered conformant.)

            <a href="terminologies.html#preferred" title="Instances are encouraged to draw from the specified codes for interoperability
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            <br/>  
            <br/>  
          </td> 
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        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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            <a href="datatypes.html#markdown">markdown</a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <a href="references.html#Reference">Reference</a> (
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

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            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> 
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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            <a href="references.html#Reference">Reference</a> (
            <a href="evidencereport.html">EvidenceReport</a>  | 
            <a href="citation.html">Citation</a>  | 
            <a href="diagnosticreport.html">DiagnosticReport</a> )
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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            <br/>  
            <br/>  
          </td> 
        </tr> 


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            <span title="ResearchStudy.webLocation : A general storage or archive location for the study.

              This may contain an assortment of content which is not specified in advance.">webLocation</span> 
            <a name="ResearchStudy.webLocation"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="types.html#BackBoneElement">BackboneElement</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">Archive location for the study
            <br/>  
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

         white">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

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            <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS

            jY/DQkad4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF
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            oTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: white; background-color: inherit" title="Data Type"/>  
            <span title="ResearchStudy.webLocation.classifier : Describes the nature of the location being

             specified.">classifier</span> 
            <a name="ResearchStudy.webLocation.classifier"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#CodeableConcept">CodeableConcept</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0

           solid; padding:0px 4px 0px 4px">registry-page|recruitment-page|contact-page
            <br/>  
            <a href="valueset-artifact-url-classifier.html">ArtifactUrlClassifier</a>  (
            <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value

             set.  The value set merely provides examples of the types of concepts intended
             to be included.">Example</a> )
            <br/>  
          </td> 
        </tr> 


        <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:

         #F7F7F7">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw

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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpw

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            uYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type"/>  
            <span title="ResearchStudy.webLocation.url : The location address.">url</span> 
            <a name="ResearchStudy.webLocation.url"> </a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#uri">uri</a> 
          </td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px

           #F0F0F0 solid; padding:0px 4px 0px 4px">The location address
            <br/>  
          </td> 
        </tr> 

        <tr> 
          <td class="hierarchy" colspan="5">
            <br/>  
            <a href="formats.html#table" title="Legend for this format">
              <img alt="doco" src="help16.png" style="background-color: inherit"/>  Documentation for this format
            </a> 
          </td> 
        </tr> 
      </table> 
    </div> 
  </text> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-category">
    <valueString value="Specialized.Public Health &amp;amp; Research"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    

    <valueInteger value="0"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category">
    <valueCode value="business"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/> 
  </extension> 
  <url value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> 
  

  <version value="5.0.0-ballot"/> 
  <name value="ResearchStudy"/> 
  <status value="draft"/> 
  
  

  <experimental value="true"/> 
  <date value="2022-09-10T04:52:37+10:00"/> 
  <publisher value="Health Level Seven International (Biomedical Research and Regulation)"/> 
  <contact> 
    <telecom> 
      <system value="url"/> 
      <value value="http://hl7.org/fhir"/> 
    </telecom> 
  </contact> 
  <contact> 
    <telecom> 
      <system value="url"/> 
      <value value="http://www.hl7.org/Special/committees/rcrim/index.cfm"/> 
    </telecom> 
  </contact> 
  A process where a researcher or organization plans and then executes a series of steps
   intended to increase the field of healthcare-related knowledge.  This includes studies
   of safety, efficacy, comparative effectiveness and other information about medications,
   devices, therapies and other interventional and investigative techniques.  A ResearchStudy
   involves the gathering of information about human or animal subjects.
  

  <description value="A scientific study of nature that sometimes includes processes involved in health
   and disease. For example, clinical trials are research studies that involve people.
   These studies may be related to new ways to screen, prevent, diagnose, and treat
   disease. They may also study certain outcomes and certain groups of people by looking
   at data collected in the past or future."/> 
  <fhirVersion value="5.0.0-ballot"/> 
  <mapping> 
    <identity value="BRIDG5.1"/> 
    <uri value="https://bridgmodel.nci.nih.gov"/> 
    <name value="BRIDG 5.1 Mapping"/> 
  </mapping> 
  <mapping> 
    <identity value="v2"/> 
    <uri value="http://hl7.org/v2"/> 
    <name value="HL7 v2 Mapping"/> 
  </mapping> 
  <mapping> 
    <identity value="rim"/> 
    <uri value="http://hl7.org/v3"/> 
    <name value="RIM Mapping"/> 
  </mapping> 
  <mapping> 
    <identity value="w5"/> 
    <uri value="http://hl7.org/fhir/fivews"/> 
    <name value="FiveWs Pattern Mapping"/> 
  </mapping> 
  <mapping> 
    <identity value="clinicaltrials-gov"/> 
    <uri value="http://clinicaltrials.gov"/> 
    <name value="ClinicalTrials.gov Mapping"/> 
  </mapping> 
  <kind value="resource"/> 
  <abstract value="false"/> 
  <type value="ResearchStudy"/> 
  <baseDefinition value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> 
  <derivation value="specialization"/> 
  <snapshot> 
    <element id="ResearchStudy">
      <path value="ResearchStudy"/> 
      <short value="Investigation to increase healthcare-related patient-independent knowledge"/> 
      A process where a researcher or organization plans and then executes a series of steps
       intended to increase the field of healthcare-related knowledge.  This includes studies
       of safety, efficacy, comparative effectiveness and other information about medications,
       devices, therapies and other interventional and investigative techniques.  A ResearchStudy
       involves the gathering of information about human or animal subjects.

      <definition value="A scientific study of nature that sometimes includes processes involved in health
       and disease. For example, clinical trials are research studies that involve people.
       These studies may be related to new ways to screen, prevent, diagnose, and treat
       disease. They may also study certain outcomes and certain groups of people by looking
       at data collected in the past or future."/> 

      <comment value="Need to make sure we encompass public health studies."/> 
      <alias value="Clinical Trial"/> 
      <alias value="Study"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <constraint> 
        <key value="dom-2"/> 
        <severity value="error"/> 
        <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/> 
        <expression value="contained.contained.empty()"/> 
        <xpath value="not(parent::f:contained and f:contained)"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> 
      </constraint> 
      <constraint> 
        <key value="dom-3"/> 
        <severity value="error"/> 
        If the resource is contained in another resource, it SHALL be referred to from elsewhere
         in the resource or SHALL refer to the containing resource
        contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descenda
        nts().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))))

        <human value="If the resource is contained in another resource, it SHALL be referred to from
         elsewhere in the resource or SHALL refer to the containing resource"/> 
        <expression value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofTy

        pe(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url)))

         or descendants().where(reference = '#').exists() or descendants().where(as(canonical)
         = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched',
         id).empty()
        not(exists(for $contained in f:contained return $contained[not(exists(parent::*/descendant::f:refere
        nce/@value=concat('#', $contained/*/f:id/@value)) or exists(descendant::f:reference[@value='#']))]))

         = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched
        ', id).empty()"/> 
        <xpath value="not(exists(for $contained in f:contained return $contained[not(exists(parent::*/descendant::f

        :reference/@value=concat('#', $contained/*/f:id/@value)) or exists(descendant::f:reference[@va
        lue='#']))]))"/> 

        <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> 
      </constraint> 
      <constraint> 
        <key value="dom-4"/> 
        <severity value="error"/> 
        If a resource is contained in another resource, it SHALL NOT have a meta.versionId or
         a meta.lastUpdated

        <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId
         or a meta.lastUpdated"/> 

        <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/> 
        

        <xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdat
        ed))"/> 

        <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> 
      </constraint> 
      <constraint> 
        <key value="dom-5"/> 
        <severity value="error"/> 
        <human value="If a resource is contained in another resource, it SHALL NOT have a security label"/> 
        <expression value="contained.meta.security.empty()"/> 
        <xpath value="not(exists(f:contained/*/f:meta/f:security))"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> 
      </constraint> 
      <constraint> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
          <valueBoolean value="true"/> 
        </extension> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
          When a resource has no narrative, only systems that fully understand the data can display
           the resource to a human safely. Including a human readable representation in the resource
           makes for a much more robust eco-system and cheaper handling of resources by intermediary
           systems. Some ecosystems restrict distribution of resources to only those systems that
           do fully understand the resources, and as a consequence implementers may believe that
           the narrative is superfluous. However experience shows that such eco-systems often open
           up to new participants over time.

          <valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can
           display the resource to a human safely. Including a human readable representation
           in the resource makes for a much more robust eco-system and cheaper handling of
           resources by intermediary systems. Some ecosystems restrict distribution of resources
           to only those systems that do fully understand the resources, and as a consequence
           implementers may believe that the narrative is superfluous. However experience
           shows that such eco-systems often open up to new participants over time."/> 

        </extension> 
        <key value="dom-6"/> 
        <severity value="warning"/> 
        <human value="A resource should have narrative for robust management"/> 
        <expression value="text.`div`.exists()"/> 
        <xpath value="exists(f:text/h:div)"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="Entity. Role, or Act"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion"/> 
      </mapping> 
      <mapping> 
        <identity value="v2"/> 
        <map value="OBX"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value="Observation[classCode=CLNTRL, moodCode=EVN]"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="clinical.diagnostics"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.id">
      <path value="ResearchStudy.id"/> 
      <short value="Logical id of this artifact"/> 
      The logical id of the resource, as used in the URL for the resource. Once assigned, this
       value never changes.
      The only time that a resource does not have an id is when it is being submitted to the
       server using a create operation.

      <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned,
       this value never changes."/> 
      <comment value="Within the context of the FHIR RESTful interactions, the resource has an id except

       for cases like the create and conditional update. Otherwise, the use of the resouce
       id depends on the given use case."/> 

      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Resource.id"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
    <!--  Note: special primitive values have a FHIRPath system type. e.g. this is compiler
       magic (j)  -->

      <type> 
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/> 
        </extension> 
        <code value="http://hl7.org/fhirpath/System.String"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
    </element> 
    <element id="ResearchStudy.meta">
      <path value="ResearchStudy.meta"/> 
      <short value="Metadata about the resource"/> 
      <definition value="The metadata about the resource. This is content that is maintained by the infrastructure.
       Changes to the content might not always be associated with version changes to the resource.

       Changes to the content might not always be associated with version changes to the
       resource."/> 

      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Resource.meta"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="Meta"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
    </element> 
    <element id="ResearchStudy.implicitRules">
      <path value="ResearchStudy.implicitRules"/> 
      <short value="A set of rules under which this content was created"/> 
      A reference to a set of rules that were followed when the resource was constructed, and
       which must be understood when processing the content. Often, this is a reference to an
       implementation guide that defines the special rules along with other profiles etc.
      Asserting this rule set restricts the content to be only understood by a limited set of
       trading partners. This inherently limits the usefulness of the data in the long term.
       However, the existing health eco-system is highly fractured, and not yet ready to define,
       collect, and exchange data in a generally computable sense. Wherever possible, implementers
       and/or specification writers should avoid using this element. Often, when used, the URL
       is a reference to an implementation guide that defines these special rules as part of
       it's narrative along with other profiles, value sets, etc.

      <definition value="A reference to a set of rules that were followed when the resource was constructed,
       and which must be understood when processing the content. Often, this is a reference
       to an implementation guide that defines the special rules along with other profiles
       etc."/> 
      <comment value="Asserting this rule set restricts the content to be only understood by a limited

       set of trading partners. This inherently limits the usefulness of the data in the
       long term. However, the existing health eco-system is highly fractured, and not
       yet ready to define, collect, and exchange data in a generally computable sense.
       Wherever possible, implementers and/or specification writers should avoid using
       this element. Often, when used, the URL is a reference to an implementation guide
       that defines these special rules as part of it's narrative along with other profiles,
       value sets, etc."/> 

      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Resource.implicitRules"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="uri"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="true"/> 
      <isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional
       knowledge about the resource that modifies it's meaning or interpretation"/> 
      <isSummary value="true"/> 
    </element> 
    <element id="ResearchStudy.language">
      <path value="ResearchStudy.language"/> 
      <short value="Language of the resource content"/> 
      <definition value="The base language in which the resource is written."/> 
      Language is provided to support indexing and accessibility (typically, services such as
       text to speech use the language tag). The html language tag in the narrative applies 
       to the narrative. The language tag on the resource may be used to specify the language
       of other presentations generated from the data in the resource. Not all the content has
       to be in the base language. The Resource.language should not be assumed to apply to the
       narrative automatically. If a language is specified, it should it also be specified on
       the div element in the html (see rules in HTML5 for information about the relationship
       between xml:lang and the html lang attribute).

      <comment value="Language is provided to support indexing and accessibility (typically, services
       such as text to speech use the language tag). The html language tag in the narrative
       applies  to the narrative. The language tag on the resource may be used to specify
       the language of other presentations generated from the data in the resource. Not
       all the content has to be in the base language. The Resource.language should not
       be assumed to apply to the narrative automatically. If a language is specified,
       it should it also be specified on the div element in the html (see rules in HTML5
       for information about the relationship between xml:lang and the html lang attribute)."/> 

      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Resource.language"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="code"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
          <valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/> 
        </extension> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="Language"/> 
        </extension> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
          <valueBoolean value="true"/> 
        </extension> 
        <strength value="preferred"/> 
        <description value="IETF language tag"/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/languages"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.text">
      <path value="ResearchStudy.text"/> 
      <short value="Text summary of the resource, for human interpretation"/> 
      A human-readable narrative that contains a summary of the resource and can be used to
       represent the content of the resource to a human. The narrative need not encode all the
       structured data, but is required to contain sufficient detail to make it &quot;clinically
       safe&quot; for a human to just read the narrative. Resource definitions may define what
       content should be represented in the narrative to ensure clinical safety.
      Contained resources do not have narrative. Resources that are not contained SHOULD have
       a narrative. In some cases, a resource may only have text with little or no additional
       discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary
       for data from legacy systems where information is captured as a &quot;text blob&quot;
       or where text is additionally entered raw or narrated and encoded information is added
       later.

      <definition value="A human-readable narrative that contains a summary of the resource and can be used
       to represent the content of the resource to a human. The narrative need not encode
       all the structured data, but is required to contain sufficient detail to make it
       &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions
       may define what content should be represented in the narrative to ensure clinical
       safety."/> 
      <comment value="Contained resources do not have a narrative. Resources that are not contained SHOULD

       have a narrative. In some cases, a resource may only have text with little or no
       additional discrete data (as long as all minOccurs=1 elements are satisfied). 
       This may be necessary for data from legacy systems where information is captured
       as a &quot;text blob&quot; or where text is additionally entered raw or narrated
       and encoded information is added later."/> 

      <alias value="narrative"/> 
      <alias value="html"/> 
      <alias value="xhtml"/> 
      <alias value="display"/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="DomainResource.text"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="Narrative"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="Act.text?"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.contained">
      <path value="ResearchStudy.contained"/> 
      <short value="Contained, inline Resources"/> 
      These resources do not have an independent existence apart from the resource that contains
       them - they cannot be identified independently, and nor can they have their own independent
       transaction scope.
      This should never be done when the content can be identified properly, as once identification
       is lost, it is extremely difficult (and context dependent) to restore it again. Contained
       resources may have profiles and tags In their meta elements, but SHALL NOT have security
       labels.

      <definition value="These resources do not have an independent existence apart from the resource that
       contains them - they cannot be identified independently, nor can they have their
       own independent transaction scope. This is allowed to be a Parameters resource
       if and only if it is referenced by a resource that provides context/meaning."/> 
      <comment value="This should never be done when the content can be identified properly, as once

       identification is lost, it is extremely difficult (and context dependent) to restore
       it again. Contained resources may have profiles and tags in their meta elements,
       but SHALL NOT have security labels."/> 

      <alias value="inline resources"/> 
      <alias value="anonymous resources"/> 
      <alias value="contained resources"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="DomainResource.contained"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Resource"/> 
      </type> 
      
        
        
        Containing new R4B resources within R4 resources may cause interoperability issues if
         instances are shared with R4 systems
        ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable
         or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this
         is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition
         or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus
         or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence
         or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefi
        nition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition
         or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorizat
        ion or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource
         is SubscriptionTopic)
        not(f:Citation|f:Evidence|f:EvidenceReport|f:EvidenceVariable|f:MedicinalProductDefinition|f:Package
        dProductDefinition|f:AdministrableProductDefinition|f:Ingredient|f:ClinicalUseDefinition|f:RegulatedA
        uthorization|f:SubstanceDefinition|f:SubscriptionStatus|f:SubscriptionTopic) or not(parent::f:Citatio
        n|parent::f:Evidence|parent::f:EvidenceReport|parent::f:EvidenceVariable|parent::f:MedicinalProductDe
        finition|parent::f:PackagedProductDefinition|parent::f:AdministrableProductDefinition|parent::f:Ingre
        dient|parent::f:ClinicalUseDefinition|parent::f:RegulatedAuthorization|parent::f:SubstanceDefinition|
        f:SubscriptionStatus|f:SubscriptionTopic)
        
      

      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.extension">
      <path value="ResearchStudy.extension"/> 
      <short value="Additional content defined by implementations"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition
       of the resource. To make the use of extensions safe and manageable, there is a strict
       set of governance  applied to the definition and use of extensions. Though any implementer
       can define an extension, there is a set of requirements that SHALL be met as part of the
       definition of the extension.
      There can be no stigma associated with the use of extensions by any application, project,
       or standard - regardless of the institution or jurisdiction that uses or defines the extensions.
        The use of extensions is what allows the FHIR specification to retain a core level of
       simplicity for everyone.

       of the resource. To make the use of extensions safe and manageable, there is a
       strict set of governance  applied to the definition and use of extensions. Though
       any implementer can define an extension, there is a set of requirements that SHALL
       be met as part of the definition of the extension."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 

      <alias value="extensions"/> 
      <alias value="user content"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="DomainResource.extension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.modifierExtension">
      <path value="ResearchStudy.modifierExtension"/> 
      <short value="Extensions that cannot be ignored"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition
       of the resource and that modifies the understanding of the element that contains it and/or
       the understanding of the containing element's descendants. Usually modifier elements provide
       negation or qualification. To make the use of extensions safe and manageable, there is
       a strict set of governance applied to the definition and use of extensions. Though any
       implementer is allowed to define an extension, there is a set of requirements that SHALL
       be met as part of the definition of the extension. Applications processing a resource
       are required to check for modifier extensions.

       of the resource and that modifies the understanding of the element that contains
       it and/or the understanding of the containing element's descendants. Usually modifier
       elements provide negation or qualification. To make the use of extensions safe
       and manageable, there is a strict set of governance applied to the definition and
       use of extensions. Though any implementer is allowed to define an extension, there
       is a set of requirements that SHALL be met as part of the definition of the extension.
       Applications processing a resource are required to check for modifier extensions.


Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource
       (including cannot change the meaning of modifierExtension itself).
      There can be no stigma associated with the use of extensions by any application, project,
       or standard - regardless of the institution or jurisdiction that uses or defines the extensions.
        The use of extensions is what allows the FHIR specification to retain a core level of
       simplicity for everyone.
      Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly
       distinguished from the vast majority of extensions which can be safely ignored.  This
       promotes interoperability by eliminating the need for implementers to prohibit the presence
       of extensions. For further information, see the [definition of modifier extensions](extensibility.ht
      ml#modifierExtension).

Modifier extensions SHALL NOT change the meaning of any elements on Resource or
       DomainResource (including cannot change the meaning of modifierExtension itself)."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be

       clearly distinguished from the vast majority of extensions which can be safely
       ignored.  This promotes interoperability by eliminating the need for implementers
       to prohibit the presence of extensions. For further information, see the [definition
       of modifier extensions](extensibility.html#modifierExtension)."/> 

      <alias value="extensions"/> 
      <alias value="user content"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="DomainResource.modifierExtension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="true"/> 
      Modifier extensions are expected to modify the meaning or interpretation of the resource
       that contains them
      

      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the
       resource that contains them"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.url">
      <path value="ResearchStudy.url"/> 
      <short value="Canonical identifier for this study resource"/> 
      <definition value="Canonical identifier for this study resource, represented as a globally unique
       URI."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.url"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="uri"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.identifier">
      <path value="ResearchStudy.identifier"/> 
      <short value="Business Identifier for study"/> 
      <definition value="Identifiers assigned to this research study by the sponsor or other systems."/> 
      Allows identification of the research study as it is known by various participating systems
       and in a way that remains consistent across servers.

      <requirements value="Allows identification of the research study as it is known by various participating
       systems and in a way that remains consistent across servers."/> 

      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.identifier"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Identifier"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Organization's Unique Protocol ID; Secondary IDs"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.identifier"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        No BRIDG mapping (although there is  DocumentVersion.identifier &gt; StudyProtocolDocumentVersion,
         this is arguably a different semantic)

        <map value="No BRIDG mapping (although there is  DocumentVersion.identifier &gt; StudyProtocolDocumentVer
        sion, this is arguably a different semantic)"/> 

      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value=".identifier"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.version">
      <path value="ResearchStudy.version"/> 
      <short value="The business version for the study record"/> 
      <definition value="The business version for the study record."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.version"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="string"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.name">
      <path value="ResearchStudy.name"/> 
      <short value="Name for this study (computer friendly)"/> 
      <definition value="Name for this study (computer friendly)."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.name"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="string"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.title">
      <path value="ResearchStudy.title"/> 
      
      

      <short value="Human readable name of the study"/> 
      <definition value="The human readable name of the research study."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.title"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="string"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Brief Title"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        No BRIDG mapping (although there is  StudyProtocolDocumentVersionPublicTitle this is arguably
         a different semantic: title of a document vs title of a research study)

        <map value="No BRIDG mapping (although there is  StudyProtocolDocumentVersionPublicTitle this
         is arguably a different semantic: title of a document vs title of a research study)"/> 

      </mapping> 
    </element> 
    <element id="ResearchStudy.label">
      <path value="ResearchStudy.label"/> 
      <short value="Additional names for the study"/> 
      <definition value="Additional names for the study."/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.label"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.label.id">
      <path value="ResearchStudy.label.id"/> 
      <representation value="xmlAttr"/> 
      <short value="Unique id for inter-element referencing"/> 
      <definition value="Unique id for the element within a resource (for internal references). This may
       be any string value that does not contain spaces."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Element.id"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
    <!--  Note: special primitive values have a FHIRPath system type. e.g. this is compiler

       magic (j)  -->
      <type> 
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/> 
        </extension> 
        <code value="http://hl7.org/fhirpath/System.String"/> 
      </type> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.label.extension">
      <path value="ResearchStudy.label.extension"/> 
      <short value="Additional content defined by implementations"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition

       of the element. To make the use of extensions safe and manageable, there is a strict
       set of governance  applied to the definition and use of extensions. Though any
       implementer can define an extension, there is a set of requirements that SHALL
       be met as part of the definition of the extension."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="Element.extension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.label.modifierExtension">
      <path value="ResearchStudy.label.modifierExtension"/> 
      <short value="Extensions that cannot be ignored even if unrecognized"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition

       of the element and that modifies the understanding of the element in which it is
       contained and/or the understanding of the containing element's descendants. Usually
       modifier elements provide negation or qualification. To make the use of extensions
       safe and manageable, there is a strict set of governance applied to the definition
       and use of extensions. Though any implementer can define an extension, there is
       a set of requirements that SHALL be met as part of the definition of the extension.
       Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or
       DomainResource (including cannot change the meaning of modifierExtension itself)."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be

       clearly distinguished from the vast majority of extensions which can be safely
       ignored.  This promotes interoperability by eliminating the need for implementers
       to prohibit the presence of extensions. For further information, see the [definition
       of modifier extensions](extensibility.html#modifierExtension)."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <alias value="modifiers"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="BackboneElement.modifierExtension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="true"/> 
      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the

       element that contains them"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.label.type">
      <path value="ResearchStudy.label.type"/> 
      <short value="primary | official | scientific | plain-language | subtitle | short-title | acronym

       | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid"/> 
      <definition value="Kind of name."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.label.type"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="TitleType"/> 
        </extension> 
        <strength value="extensible"/> 
        <description value="desc."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/title-type"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.label.value">
      <path value="ResearchStudy.label.value"/> 
      <short value="The name"/> 
      <definition value="The name."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.label.value"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="string"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.protocol">
      <path value="ResearchStudy.protocol"/> 
      <short value="Steps followed in executing study"/> 
      <definition value="The set of steps expected to be performed as part of the execution of the study."/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.protocol"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Interventions; Arm/Intervention Cross-Reference"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyProtocolDocumentVersionPublicTitle.name"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value=".outboundRelationship[typeCode=DEFN].target"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.partOf">
      <path value="ResearchStudy.partOf"/> 
      <short value="Part of larger study"/> 
      <definition value="A larger research study of which this particular study is a component or step."/> 
      Allows breaking a study into components (e.g. by study site) each with their own PI, status,
       enrollment, etc.

      <requirements value="Allows breaking a study into components (e.g. by study site) each with their own
       PI, status, enrollment, etc."/> 

      <alias value="container"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.partOf"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="CompanionStudyRelationship"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value=".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.relatedArtifact">
      <path value="ResearchStudy.relatedArtifact"/> 
      <short value="References and dependencies"/> 
      <definition value="Citations, references and other related documents."/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.relatedArtifact"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="RelatedArtifact"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Citations, Links, Available Study Data/Documents"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyProtocolDocument, StudyProtocolDocumentVersion"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.date">
      <path value="ResearchStudy.date"/> 
      <short value="Date the resource last changed"/> 
      <definition value="The date (and optionally time) when the ResearchStudy Resource was published. The
       date must change when the business version changes and it must change if the status
       code changes. In addition, it should change when the substantive content of the
       ResearchStudy Resource changes."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.date"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="dateTime"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.status">
      <path value="ResearchStudy.status"/> 
      active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervent
      ion | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-acc
      rual-and-intervention | withdrawn
      

      <short value="draft | active | retired | unknown"/> 
      <definition value="The publication state of the resource (not of the study)."/> 
      <min value="1"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.status"/> 
        <min value="1"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="code"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="true"/> 
      This element is labeled as a modifier because it is a status element that contains status
       entered-in-error which means that the resource should not be treated as valid

      <isModifierReason value="This element is labeled as a modifier because it is a status element that contains
       status entered-in-error which means that the resource should not be treated as
       valid"/> 

      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          

          <valueString value="PublicationStatus"/> 
        </extension> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
          <valueBoolean value="true"/> 
        </extension> 
        <strength value="required"/> 
        
        

        <description value="Codes that convey the current publication status of the research study resource."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/publication-status|5.0.0-ballot"/> 
      </binding> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.status"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyOverallStatus.code"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value=".status"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.primaryPurposeType">
      <path value="ResearchStudy.primaryPurposeType"/> 
      <short value="treatment | prevention | diagnostic | supportive-care | screening | health-services-research
       | basic-science | device-feasibility"/> 
      The type of study based upon the intent of the study's activities. A classification of
       the intent of the study.

      <definition value="The type of study based upon the intent of the study activities. A classification
       of the intent of the study."/> 

      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.primaryPurposeType"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyPrimaryPurposeType"/> 
        </extension> 
        <strength value="extensible"/> 
        <description value="Codes for the main intent of the study."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"/> 
      </binding> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyProtocolVersion.primaryPurposeTypeCode"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.phase">
      <path value="ResearchStudy.phase"/> 
      <short value="n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3
       | phase-4"/> 
      The stage in the progression of a therapy from initial experimental use in humans in clinical
       trials to post-market evaluation.

      <definition value="The stage in the progression of a therapy from initial experimental use in humans
       in clinical trials to post-market evaluation."/> 

      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.phase"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyPhase"/> 
        </extension> 
        <strength value="example"/> 
        Codes for the stage in the progression of a therapy from initial experimental use in humans
         in clinical trials to post-market evaluation.

        <description value="Codes for the stage in the progression of a therapy from initial experimental use
         in humans in clinical trials to post-market evaluation."/> 

        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-phase"/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Study Phase"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyProtocolVersion.phaseCode"/> 
      </mapping> 
    </element> 
    
      
      
      Codes categorizing the type of study such as investigational vs. observational, type of
       blinding, type of randomization, safety vs. efficacy, etc.

    <element id="ResearchStudy.studyDesign">
      <path value="ResearchStudy.studyDesign"/> 
      <short value="Classifications of the study design characteristics"/> 
      <definition value="Codes categorizing the type of study such as investigational vs. observational,
       type of blinding, type of randomization, safety vs. efficacy, etc."/> 

      <min value="0"/> 
      <max value="*"/> 
      <base> 
        

        <path value="ResearchStudy.studyDesign"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          

          <valueString value="StudyDesign"/> 
        </extension> 
        
        Codes that describe the type of research study.  E.g. Study phase, Interventional/Observational,
         blinding type, etc.

        <strength value="preferred"/> 
        <description value="This is a set of terms for study design characteristics."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/study-design"/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification;
         Observational Study Model; Time Perspective; Biospecimen Retention"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyP
        rotocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.
        controlTypeCode

        <map value="InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode;
         InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode;
         InterventionalStudyProtocol.controlTypeCode"/> 

      </mapping> 
    </element> 
    <element id="ResearchStudy.focus">
      <path value="ResearchStudy.focus"/> 
      <short value="Drugs, devices, etc. under study"/> 
      <definition value="The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions
       that the study is seeking to gain more information about."/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.focus"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.focus.id">
      <path value="ResearchStudy.focus.id"/> 
      <representation value="xmlAttr"/> 
      <short value="Unique id for inter-element referencing"/> 
      <definition value="Unique id for the element within a resource (for internal references). This may
       be any string value that does not contain spaces."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Element.id"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
    <!--  Note: special primitive values have a FHIRPath system type. e.g. this is compiler

       magic (j)  -->
      <type> 
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/> 
        </extension> 
        <code value="http://hl7.org/fhirpath/System.String"/> 
      </type> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.focus.extension">
      <path value="ResearchStudy.focus.extension"/> 
      <short value="Additional content defined by implementations"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition

       of the element. To make the use of extensions safe and manageable, there is a strict
       set of governance  applied to the definition and use of extensions. Though any
       implementer can define an extension, there is a set of requirements that SHALL
       be met as part of the definition of the extension."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="Element.extension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.focus.modifierExtension">
      <path value="ResearchStudy.focus.modifierExtension"/> 
      <short value="Extensions that cannot be ignored even if unrecognized"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition

       of the element and that modifies the understanding of the element in which it is
       contained and/or the understanding of the containing element's descendants. Usually
       modifier elements provide negation or qualification. To make the use of extensions
       safe and manageable, there is a strict set of governance applied to the definition
       and use of extensions. Though any implementer can define an extension, there is
       a set of requirements that SHALL be met as part of the definition of the extension.
       Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or
       DomainResource (including cannot change the meaning of modifierExtension itself)."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be

       clearly distinguished from the vast majority of extensions which can be safely
       ignored.  This promotes interoperability by eliminating the need for implementers
       to prohibit the presence of extensions. For further information, see the [definition
       of modifier extensions](extensibility.html#modifierExtension)."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <alias value="modifiers"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="BackboneElement.modifierExtension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="true"/> 
      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the

       element that contains them"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.focus.productCode">
      <path value="ResearchStudy.focus.productCode"/> 
      <short value="Identification of product under study"/> 
      <definition value="Identification of product under study.  This may be any combination of code and/or

       name."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.focus.productCode"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyFocus"/> 
        </extension> 
        <strength value="example"/> 
        <description value="Codes for medications, devices and other interventions."/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Focus of Study"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.what[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="InterventionalStudyProtocol.interventionTypeCode"/> 
      </mapping> 
    </element> 
    
      
      
      The condition that is the focus of the study.  For example, In a study to examine risk
       factors for Lupus, might have as an inclusion criterion &quot;healthy volunteer&quot;,
       but the target condition code would be a Lupus SNOMED code.

    <element id="ResearchStudy.focus.focusType">
      <path value="ResearchStudy.focus.focusType"/> 
      <short value="medication | device | intervention | factor"/> 
      <definition value="Indicates whether the focus is a medication, a device, a procedure, a specific
       factor or some other intervention or characteristic."/> 

      <min value="0"/> 
      <max value="*"/> 
      <base> 
        

        <path value="ResearchStudy.focus.focusType"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      

      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          

          <valueString value="ResearchStudyFocusType"/> 
        </extension> 
        
        
        

        <strength value="extensible"/> 
        <description value="defn."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-focus-type"/> 
      </binding> 
      
        
        
      
      
        
        
      
      
        
        
      

    </element> 
    
      
      
      

    <element id="ResearchStudy.focus.factor">
      <path value="ResearchStudy.focus.factor"/> 
      <short value="An independent variable manipulated by the experimentalist"/> 
      <definition value="A factor corresponds to an independent variable manipulated by the experimentalist
       with the intention to affect biological systems in a way that can be measured by
       an assay."/> 

      <min value="0"/> 
      

      <max value="1"/> 
      <base> 
        

        <path value="ResearchStudy.focus.factor"/> 
        <min value="0"/> 
        

        <max value="1"/> 
      </base> 
      <type> 
        

        <code value="markdown"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      
      
        
        Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact &amp;
         Backup (if Study tied to only one location); Investigators
      
      
        
        PointOfContact &gt; Project &gt; Research Project &gt; Study &gt; StudyProtocol &gt; StudyProtocolVe
        rsion
      

      <isSummary value="false"/> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.condition">
      <path value="ResearchStudy.condition"/> 
      <short value="Condition being studied"/> 
      <definition value="The condition that is the focus of the study.  For example, In a study to examine
       risk factors for Lupus, might have as an inclusion criterion &quot;healthy volunteer&quot;,
       but the target condition code would be a Lupus SNOMED code."/> 

      <min value="0"/> 
      <max value="*"/> 
      <base> 
        

        <path value="ResearchStudy.condition"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        

        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      

      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ConditionCode"/> 
        </extension> 
        <strength value="example"/> 
        <description value="Identification of the condition or diagnosis."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/condition-code"/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        

        <map value="Conditions"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.what[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        

        <map value="StudyCondition.code"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.keyword">
      <path value="ResearchStudy.keyword"/> 
      <short value="Used to search for the study"/> 
      <definition value="Key terms to aid in searching for or filtering the study."/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.keyword"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyKeyword"/> 
        </extension> 
        <strength value="example"/> 
        <description value="Words associated with the study that may be useful in discovery."/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Keywords"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="DocumentVersion.keywordCode; DocumentVersion.keywordText"/> 
      </mapping> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.region">
      <path value="ResearchStudy.region"/> 
      <short value="Geographic area for the study"/> 
      <definition value="A country, state or other area where the study is taking place rather than its
       precise geographic location or address."/> 

      <min value="0"/> 
      <max value="*"/> 
      <base> 
        

        <path value="ResearchStudy.region"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="Jurisdiction"/> 
        </extension> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
          <valueBoolean value="true"/> 
        </extension> 
        <strength value="extensible"/> 
        <description value="Countries and regions within which this artifact is targeted for use."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/> 
      </binding> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyProtocolVersion.participatingLocationCode"/> 
      </mapping> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.descriptionSummary">
      <path value="ResearchStudy.descriptionSummary"/> 
      <short value="Brief text explaining the study"/> 
      <definition value="A brief text for explaining the study."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        

        <path value="ResearchStudy.descriptionSummary"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="markdown"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      
        
        
      
      
        
        
      

    </element> 
    
      
      
      Reference to a Group that defines the criteria for and quantity of subjects participating
       in the study.  E.g. &quot; 200 female Europeans between the ages of 20 and 45 with early
       onset diabetes&quot;.
      The Group referenced should not generally enumerate specific subjects.  Subjects will
       be linked to the study using the ResearchSubject resource.
      

    <element id="ResearchStudy.description">
      <path value="ResearchStudy.description"/> 
      <short value="Detailed narrative of the study"/> 
      <definition value="A detailed and human-readable narrative of the study. E.g., study abstract."/> 
      <min value="0"/> 
      

      <max value="1"/> 
      <base> 
        

        <path value="ResearchStudy.description"/> 
        <min value="0"/> 
        

        <max value="1"/> 
      </base> 
      <type> 
        
        

        <code value="markdown"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      

      <isSummary value="false"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        Enrollment; Number of Groups/Cohorts (= number of &quot;enrollment&quot; instances); Groups
         (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility
         (Group criteria)
      
      
        
        

        <map value="Detailed Description"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        
      
      
        
        
      
      
        
        

        <map value="StudyProtocolDocumentVersion.publicDescription"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.period">
      <path value="ResearchStudy.period"/> 
      <short value="When the study began and ended"/> 
      Identifies the start date and the expected (or actual, depending on status) end date for
       the study.

      <definition value="Identifies the start date and the expected (or actual, depending on status) end
       date for the study."/> 

      <alias value="timing"/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.period"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="Period"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Study Start Date (start); Study Completion Date (end)"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.done[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value=".effectiveTime"/> 
      </mapping> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.site">
      <path value="ResearchStudy.site"/> 
      <short value="Facility where study activities are conducted"/> 
      <definition value="A facility in which study activities are conducted."/> 
      <min value="0"/> 
      

      <max value="*"/> 
      <base> 
        

        <path value="ResearchStudy.site"/> 
        <min value="0"/> 
        

        <max value="*"/> 
      </base> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        

        <map value="Facility"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        

        <map value="FiveWs.where[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        

        <map value="PlannedStudySite; StudySite"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.note">
      <path value="ResearchStudy.note"/> 
      <short value="Comments made about the study"/> 
      <definition value="Comments made about the study by the performer, subject or other participants."/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.note"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Annotation"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="No BRIDG mapping"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        

        <map value=".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"/> 
      </mapping> 
    </element> 
    
      
      
      A researcher in a study who oversees multiple aspects of the study, such as concept development,
       protocol writing, protocol submission for IRB approval, participant recruitment, informed
       consent, data collection, analysis, interpretation and presentation.

    <element id="ResearchStudy.classifier">
      <path value="ResearchStudy.classifier"/> 
      <short value="Classification for the study"/> 
      <definition value="Additional grouping mechanism or categorization of a research study. Example: FDA
       regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement),
       IRB-exempt, etc. Implementation Note: do not use the classifier element to support
       existing semantics that are already supported thru explicit elements in the resource."/> 

      <min value="0"/> 
      

      <max value="*"/> 
      <base> 
        

        <path value="ResearchStudy.classifier"/> 
        <min value="0"/> 
        

        <max value="*"/> 
      </base> 
      <type> 
        
        
        

        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      

      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyClassifiers"/> 
        </extension> 
        <strength value="example"/> 
        <description value="desc."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-classifiers"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.associatedParty">
      <path value="ResearchStudy.associatedParty"/> 
      <short value="Sponsors, collaborators, and other parties"/> 
      <definition value="Sponsors, collaborators, and other parties."/> 
      <comment value="For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided."/> 
      <requirements value="While there are explicit attributes for a Sponsor and a PrincipalInvestigator many
       trial record a range of other organizations and individuals in key roles."/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.associatedParty"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.associatedParty.id">
      <path value="ResearchStudy.associatedParty.id"/> 
      <representation value="xmlAttr"/> 
      <short value="Unique id for inter-element referencing"/> 
      <definition value="Unique id for the element within a resource (for internal references). This may

       be any string value that does not contain spaces."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Element.id"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
    <!--  Note: special primitive values have a FHIRPath system type. e.g. this is compiler

       magic (j)  -->
      <type> 
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/> 
        </extension> 
        <code value="http://hl7.org/fhirpath/System.String"/> 
      </type> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        
        

        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.associatedParty.extension">
      <path value="ResearchStudy.associatedParty.extension"/> 
      <short value="Additional content defined by implementations"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition
       of the element. To make the use of extensions safe and manageable, there is a strict
       set of governance  applied to the definition and use of extensions. Though any
       implementer can define an extension, there is a set of requirements that SHALL
       be met as part of the definition of the extension."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="Element.extension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        
        

        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.associatedParty.modifierExtension">
      <path value="ResearchStudy.associatedParty.modifierExtension"/> 
      <short value="Extensions that cannot be ignored even if unrecognized"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition
       of the element and that modifies the understanding of the element in which it is
       contained and/or the understanding of the containing element's descendants. Usually
       modifier elements provide negation or qualification. To make the use of extensions
       safe and manageable, there is a strict set of governance applied to the definition
       and use of extensions. Though any implementer can define an extension, there is
       a set of requirements that SHALL be met as part of the definition of the extension.
       Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or
       DomainResource (including cannot change the meaning of modifierExtension itself)."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be

       clearly distinguished from the vast majority of extensions which can be safely
       ignored.  This promotes interoperability by eliminating the need for implementers
       to prohibit the presence of extensions. For further information, see the [definition
       of modifier extensions](extensibility.html#modifierExtension)."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <alias value="modifiers"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="BackboneElement.modifierExtension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="true"/> 
      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the

       element that contains them"/> 
      <isSummary value="true"/> 
      <mapping> 
        
        

        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.associatedParty.name">
      <path value="ResearchStudy.associatedParty.name"/> 
      <short value="Name of associated party"/> 
      <definition value="Name of associated party."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.associatedParty.name"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="string"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.associatedParty.role">
      <path value="ResearchStudy.associatedParty.role"/> 
      <short value="sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator
       | funding-source | general-contact | recruitment-contact | sub-investigator | study-director
       | study-chair"/> 
      <definition value="Type of association."/> 
      <min value="1"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.associatedParty.role"/> 
        <min value="1"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyPartyRole"/> 
        </extension> 
        <strength value="extensible"/> 
        <description value="desc."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-party-role"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.associatedParty.period">
      <path value="ResearchStudy.associatedParty.period"/> 
      <short value="When active in the role"/> 
      <definition value="Identifies the start date and the end date of the associated party in the role."/> 
      <comment value="The cardinality is 0..* due to the fact that an associated party may be intermittently

       active in a given role over multiple time periods."/> 

      <min value="0"/> 
      <max value="*"/> 
      <base> 
        

        <path value="ResearchStudy.associatedParty.period"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Period"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.associatedParty.classifier">
      <path value="ResearchStudy.associatedParty.classifier"/> 
      <short value="nih | fda | government | nonprofit | academic | industry"/> 
      <definition value="A categorization other than role for the associated party."/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.associatedParty.classifier"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyPartyOrganizationType"/> 
        </extension> 
        <strength value="example"/> 
        <description value="A characterization or type of the entity."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-party-org-type"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.associatedParty.party">
      <path value="ResearchStudy.associatedParty.party"/> 
      <short value="Individual or organization associated with study (use practitionerRole to specify
       their organisation)"/> 
      <definition value="Individual or organization associated with study (use practitionerRole to specify

       their organisation)."/> 
      <comment value="Suggestions of a better attribute name are appreciated"/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.associatedParty.party"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="Reference"/> 
        

        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      

      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.progressStatus">
      <path value="ResearchStudy.progressStatus"/> 
      <short value="Status of study with time for that status"/> 
      <definition value="Status of study with time for that status."/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.progressStatus"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.progressStatus.id">
      <path value="ResearchStudy.progressStatus.id"/> 
      <representation value="xmlAttr"/> 
      <short value="Unique id for inter-element referencing"/> 
      <definition value="Unique id for the element within a resource (for internal references). This may
       be any string value that does not contain spaces."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Element.id"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
    <!--  Note: special primitive values have a FHIRPath system type. e.g. this is compiler

       magic (j)  -->
      <type> 
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/> 
        </extension> 
        <code value="http://hl7.org/fhirpath/System.String"/> 
      </type> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        
        

        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.progressStatus.extension">
      <path value="ResearchStudy.progressStatus.extension"/> 
      <short value="Additional content defined by implementations"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition
       of the element. To make the use of extensions safe and manageable, there is a strict
       set of governance  applied to the definition and use of extensions. Though any
       implementer can define an extension, there is a set of requirements that SHALL
       be met as part of the definition of the extension."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="Element.extension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        
        

        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.progressStatus.modifierExtension">
      <path value="ResearchStudy.progressStatus.modifierExtension"/> 
      <short value="Extensions that cannot be ignored even if unrecognized"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition
       of the element and that modifies the understanding of the element in which it is
       contained and/or the understanding of the containing element's descendants. Usually
       modifier elements provide negation or qualification. To make the use of extensions
       safe and manageable, there is a strict set of governance applied to the definition
       and use of extensions. Though any implementer can define an extension, there is
       a set of requirements that SHALL be met as part of the definition of the extension.
       Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or
       DomainResource (including cannot change the meaning of modifierExtension itself)."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be

       clearly distinguished from the vast majority of extensions which can be safely
       ignored.  This promotes interoperability by eliminating the need for implementers
       to prohibit the presence of extensions. For further information, see the [definition
       of modifier extensions](extensibility.html#modifierExtension)."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <alias value="modifiers"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="BackboneElement.modifierExtension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="true"/> 
      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the

       element that contains them"/> 
      <isSummary value="true"/> 
      <mapping> 
        
        

        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
    
      
      accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-close
      d-per-study-design

    <element id="ResearchStudy.progressStatus.state">
      <path value="ResearchStudy.progressStatus.state"/> 
      <short value="Label for status or state (e.g. recruitment status)"/> 
      <definition value="Label for status or state (e.g. recruitment status)."/> 
      <min value="1"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.progressStatus.state"/> 
        <min value="1"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyStudyStatus"/> 
        </extension> 
        <strength value="extensible"/> 
        <description value="defn."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-status"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.progressStatus.actual">
      <path value="ResearchStudy.progressStatus.actual"/> 
      <short value="Actual if true else anticipated"/> 
      <definition value="An indication of whether or not the date is a known date when the state changed
       or will change. A value of true indicates a known date. A value of false indicates
       an estimated date."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.progressStatus.actual"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="boolean"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.progressStatus.period">
      <path value="ResearchStudy.progressStatus.period"/> 
      <short value="Date range"/> 
      <definition value="Date range."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.progressStatus.period"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="Period"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.whyStopped">
      <path value="ResearchStudy.whyStopped"/> 
      <short value="accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress

       | temporarily-closed-per-study-design"/> 

      <definition value="A description and/or code explaining the premature termination of the study."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        

        <path value="ResearchStudy.whyStopped"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyReasonStopped"/> 
        </extension> 
        <strength value="example"/> 
        <description value="Codes for why the study ended prematurely."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-reason-stopped"/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Why Study Stopped"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.why[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyOverallStatus.studyStoppedReasonCode"/> 
      </mapping> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.recruitment">
      <path value="ResearchStudy.recruitment"/> 
      <short value="Target or actual group of participants enrolled in study"/> 
      <definition value="Target or actual group of participants enrolled in study."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.recruitment"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Enrollment; Number of Groups/Cohorts (= number of &quot;enrollment&quot; instances);
         Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description);
         Eligibility (Group criteria)"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.subject[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="InterventionalStudyProtocol.interventionGroupQuantity"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value=".participation[typeCode=SBJ].role"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.subject"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.recruitment.id">
      <path value="ResearchStudy.recruitment.id"/> 
      <representation value="xmlAttr"/> 
      <short value="Unique id for inter-element referencing"/> 
      <definition value="Unique id for the element within a resource (for internal references). This may

       be any string value that does not contain spaces."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Element.id"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
    <!--  Note: special primitive values have a FHIRPath system type. e.g. this is compiler

       magic (j)  -->
      <type> 
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/> 
        </extension> 
        <code value="http://hl7.org/fhirpath/System.String"/> 
      </type> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.recruitment.extension">
      <path value="ResearchStudy.recruitment.extension"/> 
      <short value="Additional content defined by implementations"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition

       of the element. To make the use of extensions safe and manageable, there is a strict
       set of governance  applied to the definition and use of extensions. Though any
       implementer can define an extension, there is a set of requirements that SHALL
       be met as part of the definition of the extension."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        

        <path value="Element.extension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        

        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.recruitment.modifierExtension">
      <path value="ResearchStudy.recruitment.modifierExtension"/> 
      <short value="Extensions that cannot be ignored even if unrecognized"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition
       of the element and that modifies the understanding of the element in which it is
       contained and/or the understanding of the containing element's descendants. Usually
       modifier elements provide negation or qualification. To make the use of extensions
       safe and manageable, there is a strict set of governance applied to the definition
       and use of extensions. Though any implementer can define an extension, there is
       a set of requirements that SHALL be met as part of the definition of the extension.
       Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or
       DomainResource (including cannot change the meaning of modifierExtension itself)."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be

       clearly distinguished from the vast majority of extensions which can be safely
       ignored.  This promotes interoperability by eliminating the need for implementers
       to prohibit the presence of extensions. For further information, see the [definition
       of modifier extensions](extensibility.html#modifierExtension)."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <alias value="modifiers"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="BackboneElement.modifierExtension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="true"/> 
      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the

       element that contains them"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.recruitment.targetNumber">
      <path value="ResearchStudy.recruitment.targetNumber"/> 
      <short value="Estimated total number of participants to be enrolled"/> 
      <definition value="Estimated total number of participants to be enrolled."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.recruitment.targetNumber"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="unsignedInt"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.recruitment.actualNumber">
      <path value="ResearchStudy.recruitment.actualNumber"/> 
      <short value="Actual total number of participants enrolled in study"/> 
      <definition value="Actual total number of participants enrolled in study."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.recruitment.actualNumber"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="unsignedInt"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.recruitment.eligibility">
      <path value="ResearchStudy.recruitment.eligibility"/> 
      <short value="Inclusion and exclusion criteria"/> 
      <definition value="Inclusion and exclusion criteria."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.recruitment.eligibility"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/EvidenceVariable"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.recruitment.actualGroup">
      <path value="ResearchStudy.recruitment.actualGroup"/> 
      <short value="Group of participants who were enrolled in study"/> 
      <definition value="Group of participants who were enrolled in study."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.recruitment.actualGroup"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Enrollment; Number of Groups/Cohorts (= number of &quot;enrollment&quot; instances);
         Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description);
         Eligibility (Group criteria)"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.subject[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        

        <map value="InterventionalStudyProtocol.interventionGroupQuantity"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        

        <map value=".participation[typeCode=SBJ].role"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.subject"/> 
      </mapping> 
    </element> 
    
      

    <element id="ResearchStudy.comparisonGroup">
      <path value="ResearchStudy.comparisonGroup"/> 
      <short value="Defined path through the study for a subject"/> 
      Describes an expected sequence of events for one of the participants of a study.  E.g.
       Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.

      <definition value="Describes an expected sequence of events for one of the participants of a study.
        E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up."/> 
      <comment value="In many clinical trials this is refered to as the ARM of the study, but such a

       term is not used in other sorts of trials even when there is a comparison between
       two or more groups."/> 
      <alias value="arm"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        

        <path value="ResearchStudy.comparisonGroup"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        
        
        

        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Arms"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="Arm"/> 
      </mapping> 
    </element> 
    
      

    <element id="ResearchStudy.comparisonGroup.id">
      <path value="ResearchStudy.comparisonGroup.id"/> 
      <representation value="xmlAttr"/> 
      <short value="Unique id for inter-element referencing"/> 
      Unique id for the element within a resource (for internal references). This may be any
       string value that does not contain spaces.

      <definition value="Unique id for the element within a resource (for internal references). This may
       be any string value that does not contain spaces."/> 

      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Element.id"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
    <!--  Note: special primitive values have a FHIRPath system type. e.g. this is compiler
       magic (j)  -->

      <type> 
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/> 
        </extension> 
        <code value="http://hl7.org/fhirpath/System.String"/> 
      </type> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    
      

    <element id="ResearchStudy.comparisonGroup.extension">
      <path value="ResearchStudy.comparisonGroup.extension"/> 
      <short value="Additional content defined by implementations"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition
       of the element. To make the use of extensions safe and manageable, there is a strict set
       of governance  applied to the definition and use of extensions. Though any implementer
       can define an extension, there is a set of requirements that SHALL be met as part of the
       definition of the extension.
      There can be no stigma associated with the use of extensions by any application, project,
       or standard - regardless of the institution or jurisdiction that uses or defines the extensions.
        The use of extensions is what allows the FHIR specification to retain a core level of
       simplicity for everyone.

       of the element. To make the use of extensions safe and manageable, there is a strict
       set of governance  applied to the definition and use of extensions. Though any
       implementer can define an extension, there is a set of requirements that SHALL
       be met as part of the definition of the extension."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 

      <alias value="extensions"/> 
      <alias value="user content"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="Element.extension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    
      

    <element id="ResearchStudy.comparisonGroup.modifierExtension">
      <path value="ResearchStudy.comparisonGroup.modifierExtension"/> 
      <short value="Extensions that cannot be ignored even if unrecognized"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition
       of the element and that modifies the understanding of the element in which it is contained
       and/or the understanding of the containing element's descendants. Usually modifier elements
       provide negation or qualification. To make the use of extensions safe and manageable,
       there is a strict set of governance applied to the definition and use of extensions. Though
       any implementer can define an extension, there is a set of requirements that SHALL be
       met as part of the definition of the extension. Applications processing a resource are
       required to check for modifier extensions.

       of the element and that modifies the understanding of the element in which it is
       contained and/or the understanding of the containing element's descendants. Usually
       modifier elements provide negation or qualification. To make the use of extensions
       safe and manageable, there is a strict set of governance applied to the definition
       and use of extensions. Though any implementer can define an extension, there is
       a set of requirements that SHALL be met as part of the definition of the extension.
       Applications processing a resource are required to check for modifier extensions.


Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource
       (including cannot change the meaning of modifierExtension itself).
      There can be no stigma associated with the use of extensions by any application, project,
       or standard - regardless of the institution or jurisdiction that uses or defines the extensions.
        The use of extensions is what allows the FHIR specification to retain a core level of
       simplicity for everyone.
      Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly
       distinguished from the vast majority of extensions which can be safely ignored.  This
       promotes interoperability by eliminating the need for implementers to prohibit the presence
       of extensions. For further information, see the [definition of modifier extensions](extensibility.ht
      ml#modifierExtension).

Modifier extensions SHALL NOT change the meaning of any elements on Resource or
       DomainResource (including cannot change the meaning of modifierExtension itself)."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be

       clearly distinguished from the vast majority of extensions which can be safely
       ignored.  This promotes interoperability by eliminating the need for implementers
       to prohibit the presence of extensions. For further information, see the [definition
       of modifier extensions](extensibility.html#modifierExtension)."/> 

      <alias value="extensions"/> 
      <alias value="user content"/> 
      <alias value="modifiers"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="BackboneElement.modifierExtension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="true"/> 
      Modifier extensions are expected to modify the meaning or interpretation of the element
       that contains them

      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the
       element that contains them"/> 

      <isSummary value="true"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.comparisonGroup.identifier[x]">
      <path value="ResearchStudy.comparisonGroup.identifier[x]"/> 
      <short value="Allows the comparisonGroup for the study and the comparisonGroup for the subject
       to be linked easily"/> 
      <definition value="Allows the comparisonGroup for the study and the comparisonGroup for the subject

       to be linked easily."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.comparisonGroup.identifier[x]"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="uri"/> 
      </type> 
      <type> 
        <code value="Identifier"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.comparisonGroup.name">
      <path value="ResearchStudy.comparisonGroup.name"/> 
      <short value="Label for study comparisonGroup"/> 
      <definition value="Unique, human-readable label for this comparisonGroup of the study."/> 
      <min value="1"/> 
      <max value="1"/> 
      <base> 
        

        <path value="ResearchStudy.comparisonGroup.name"/> 
        <min value="1"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="string"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Arm Label"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="Arm.name"/> 
      </mapping> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.comparisonGroup.type">
      <path value="ResearchStudy.comparisonGroup.type"/> 
      <short value="Categorization of study comparisonGroup"/> 
      <definition value="Categorization of study comparisonGroup, e.g. experimental, active comparator,
       placebo comparater."/> 

      <min value="0"/> 
      <max value="1"/> 
      <base> 
        

        <path value="ResearchStudy.comparisonGroup.type"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyArmType"/> 
        </extension> 
        <strength value="extensible"/> 
        <description value="desc."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-arm-type"/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Arm Type"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="Arm.typeCode"/> 
      </mapping> 
    </element> 
    
      

    <element id="ResearchStudy.comparisonGroup.description">
      <path value="ResearchStudy.comparisonGroup.description"/> 
      <short value="Short explanation of study path"/> 
      A succinct description of the path through the study that would be followed by a subject
       adhering to this arm.

      <definition value="A succinct description of the path through the study that would be followed by
       a subject adhering to this comparisonGroup."/> 

      <min value="0"/> 
      <max value="1"/> 
      <base> 
        

        <path value="ResearchStudy.comparisonGroup.description"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        

        <code value="markdown"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Arm Description"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="Arm.description"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.comparisonGroup.intendedExposure">
      <path value="ResearchStudy.comparisonGroup.intendedExposure"/> 
      <short value="Interventions or exposures in this comparisonGroup or cohort"/> 
      <definition value="Interventions or exposures in this comparisonGroup or cohort."/> 
      <requirements value="this is necessary for ClinicalTrials.gov use which relates  1 to many interventions
       to comparisonGroups (aka arms)"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.comparisonGroup.intendedExposure"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/EvidenceVariable"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.comparisonGroup.observedGroup">
      <path value="ResearchStudy.comparisonGroup.observedGroup"/> 
      <short value="Group of participants who were enrolled in study comparisonGroup"/> 
      <definition value="Group of participants who were enrolled in study comparisonGroup."/> 
      <requirements value="This is necessary to relate comparisonGroups to actual groups"/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.comparisonGroup.observedGroup"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.objective">
      <path value="ResearchStudy.objective"/> 
      <short value="A goal for the study"/> 
      A goal that the study is aiming to achieve in terms of a scientific question to be answered
       by the analysis of data collected during the study.

      <definition value="A goal that the study is aiming to achieve in terms of a scientific question to
       be answered by the analysis of data collected during the study."/> 

      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.objective"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        
        
        

        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyObjective"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.objective.id">
      <path value="ResearchStudy.objective.id"/> 
      <representation value="xmlAttr"/> 
      <short value="Unique id for inter-element referencing"/> 
      Unique id for the element within a resource (for internal references). This may be any
       string value that does not contain spaces.

      <definition value="Unique id for the element within a resource (for internal references). This may
       be any string value that does not contain spaces."/> 

      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Element.id"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
    <!--  Note: special primitive values have a FHIRPath system type. e.g. this is compiler
       magic (j)  -->

      <type> 
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/> 
        </extension> 
        <code value="http://hl7.org/fhirpath/System.String"/> 
      </type> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.objective.extension">
      <path value="ResearchStudy.objective.extension"/> 
      <short value="Additional content defined by implementations"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition
       of the element. To make the use of extensions safe and manageable, there is a strict set
       of governance  applied to the definition and use of extensions. Though any implementer
       can define an extension, there is a set of requirements that SHALL be met as part of the
       definition of the extension.
      There can be no stigma associated with the use of extensions by any application, project,
       or standard - regardless of the institution or jurisdiction that uses or defines the extensions.
        The use of extensions is what allows the FHIR specification to retain a core level of
       simplicity for everyone.

       of the element. To make the use of extensions safe and manageable, there is a strict
       set of governance  applied to the definition and use of extensions. Though any
       implementer can define an extension, there is a set of requirements that SHALL
       be met as part of the definition of the extension."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 

      <alias value="extensions"/> 
      <alias value="user content"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="Element.extension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.objective.modifierExtension">
      <path value="ResearchStudy.objective.modifierExtension"/> 
      <short value="Extensions that cannot be ignored even if unrecognized"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition
       of the element and that modifies the understanding of the element in which it is contained
       and/or the understanding of the containing element's descendants. Usually modifier elements
       provide negation or qualification. To make the use of extensions safe and manageable,
       there is a strict set of governance applied to the definition and use of extensions. Though
       any implementer can define an extension, there is a set of requirements that SHALL be
       met as part of the definition of the extension. Applications processing a resource are
       required to check for modifier extensions.

       of the element and that modifies the understanding of the element in which it is
       contained and/or the understanding of the containing element's descendants. Usually
       modifier elements provide negation or qualification. To make the use of extensions
       safe and manageable, there is a strict set of governance applied to the definition
       and use of extensions. Though any implementer can define an extension, there is
       a set of requirements that SHALL be met as part of the definition of the extension.
       Applications processing a resource are required to check for modifier extensions.


Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource
       (including cannot change the meaning of modifierExtension itself).
      There can be no stigma associated with the use of extensions by any application, project,
       or standard - regardless of the institution or jurisdiction that uses or defines the extensions.
        The use of extensions is what allows the FHIR specification to retain a core level of
       simplicity for everyone.
      Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly
       distinguished from the vast majority of extensions which can be safely ignored.  This
       promotes interoperability by eliminating the need for implementers to prohibit the presence
       of extensions. For further information, see the [definition of modifier extensions](extensibility.ht
      ml#modifierExtension).

Modifier extensions SHALL NOT change the meaning of any elements on Resource or
       DomainResource (including cannot change the meaning of modifierExtension itself)."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be

       clearly distinguished from the vast majority of extensions which can be safely
       ignored.  This promotes interoperability by eliminating the need for implementers
       to prohibit the presence of extensions. For further information, see the [definition
       of modifier extensions](extensibility.html#modifierExtension)."/> 

      <alias value="extensions"/> 
      <alias value="user content"/> 
      <alias value="modifiers"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="BackboneElement.modifierExtension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="true"/> 
      Modifier extensions are expected to modify the meaning or interpretation of the element
       that contains them

      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the
       element that contains them"/> 

      <isSummary value="true"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.objective.name">
      <path value="ResearchStudy.objective.name"/> 
      <short value="Label for the objective"/> 
      <definition value="Unique, human-readable label for this objective of the study."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.objective.name"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="string"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="No BRIDG mapping (BRIDG has a description, but not a name)"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.objective.type">
      <path value="ResearchStudy.objective.type"/> 
      <short value="primary | secondary | exploratory"/> 
      <definition value="The kind of study objective."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.objective.type"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyObjectiveType"/> 
        </extension> 
        <strength value="preferred"/> 
        <description value="Codes for the kind of study objective."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-objective-type"/> 
      </binding> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyObjective.typeCode"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.objective.description">
      <path value="ResearchStudy.objective.description"/> 
      <short value="Description of the objective"/> 
      <definition value="Free text description of the objective of the study.  This is what the study is
       trying to achieve rather than how it is going to achieve it (see ResearchStudy.description)."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.objective.description"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="markdown"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.outcomeMeasure">
      <path value="ResearchStudy.outcomeMeasure"/> 
      <short value="An outcome or planned variable to measure during the study"/> 
      <definition value="An outcome or planned variable to measure during the study."/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.outcomeMeasure"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.outcomeMeasure.id">
      <path value="ResearchStudy.outcomeMeasure.id"/> 
      <representation value="xmlAttr"/> 
      <short value="Unique id for inter-element referencing"/> 
      <definition value="Unique id for the element within a resource (for internal references). This may

       be any string value that does not contain spaces."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Element.id"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
    <!--  Note: special primitive values have a FHIRPath system type. e.g. this is compiler

       magic (j)  -->
      <type> 
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/> 
        </extension> 
        <code value="http://hl7.org/fhirpath/System.String"/> 
      </type> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.outcomeMeasure.extension">
      <path value="ResearchStudy.outcomeMeasure.extension"/> 
      <short value="Additional content defined by implementations"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition

       of the element. To make the use of extensions safe and manageable, there is a strict
       set of governance  applied to the definition and use of extensions. Though any
       implementer can define an extension, there is a set of requirements that SHALL
       be met as part of the definition of the extension."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="Element.extension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.outcomeMeasure.modifierExtension">
      <path value="ResearchStudy.outcomeMeasure.modifierExtension"/> 
      <short value="Extensions that cannot be ignored even if unrecognized"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition

       of the element and that modifies the understanding of the element in which it is
       contained and/or the understanding of the containing element's descendants. Usually
       modifier elements provide negation or qualification. To make the use of extensions
       safe and manageable, there is a strict set of governance applied to the definition
       and use of extensions. Though any implementer can define an extension, there is
       a set of requirements that SHALL be met as part of the definition of the extension.
       Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or
       DomainResource (including cannot change the meaning of modifierExtension itself)."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be

       clearly distinguished from the vast majority of extensions which can be safely
       ignored.  This promotes interoperability by eliminating the need for implementers
       to prohibit the presence of extensions. For further information, see the [definition
       of modifier extensions](extensibility.html#modifierExtension)."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <alias value="modifiers"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="BackboneElement.modifierExtension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="true"/> 
      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the

       element that contains them"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.outcomeMeasure.name">
      <path value="ResearchStudy.outcomeMeasure.name"/> 
      <short value="Label for the outcome"/> 
      <definition value="Label for the outcome."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.outcomeMeasure.name"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="string"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.outcomeMeasure.type">
      <path value="ResearchStudy.outcomeMeasure.type"/> 
      <short value="primary | secondary | exploratory"/> 
      <definition value="The parameter or characteristic being assessed as one of the values by which the

       study is assessed."/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.outcomeMeasure.type"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyObjectiveType"/> 
        </extension> 
        <strength value="preferred"/> 
        <description value="defn."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-objective-type"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.outcomeMeasure.description">
      <path value="ResearchStudy.outcomeMeasure.description"/> 
      <short value="Description of the outcome"/> 
      <definition value="Description of the outcome."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.outcomeMeasure.description"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="markdown"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.outcomeMeasure.reference">
      <path value="ResearchStudy.outcomeMeasure.reference"/> 
      <short value="Structured outcome definition"/> 
      <definition value="Structured outcome definition."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.outcomeMeasure.reference"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/EvidenceVariable"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.result">
      <path value="ResearchStudy.result"/> 
      <short value="Link to results generated during the study"/> 
      <definition value="Link to one or more sets of results generated by the study.  Could also link to

       a research registry holding the results such as ClinicalTrials.gov."/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.result"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/EvidenceReport"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Citation"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/DiagnosticReport"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
    </element> 
    <element id="ResearchStudy.webLocation">
      <path value="ResearchStudy.webLocation"/> 
      <short value="Archive location for the study"/> 
      <definition value="A general storage or archive location for the study.  This may contain an assortment

       of content which is not specified in advance."/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="ResearchStudy.webLocation"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.webLocation.id">
      <path value="ResearchStudy.webLocation.id"/> 
      <representation value="xmlAttr"/> 
      <short value="Unique id for inter-element referencing"/> 
      <definition value="Unique id for the element within a resource (for internal references). This may

       be any string value that does not contain spaces."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="Element.id"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
    <!--  Note: special primitive values have a FHIRPath system type. e.g. this is compiler

       magic (j)  -->
      <type> 
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/> 
        </extension> 
        <code value="http://hl7.org/fhirpath/System.String"/> 
      </type> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.webLocation.extension">
      <path value="ResearchStudy.webLocation.extension"/> 
      <short value="Additional content defined by implementations"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition

       of the element. To make the use of extensions safe and manageable, there is a strict
       set of governance  applied to the definition and use of extensions. Though any
       implementer can define an extension, there is a set of requirements that SHALL
       be met as part of the definition of the extension."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="Element.extension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="n/a"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.webLocation.modifierExtension">
      <path value="ResearchStudy.webLocation.modifierExtension"/> 
      <short value="Extensions that cannot be ignored even if unrecognized"/> 
      <definition value="May be used to represent additional information that is not part of the basic definition

       of the element and that modifies the understanding of the element in which it is
       contained and/or the understanding of the containing element's descendants. Usually
       modifier elements provide negation or qualification. To make the use of extensions
       safe and manageable, there is a strict set of governance applied to the definition
       and use of extensions. Though any implementer can define an extension, there is
       a set of requirements that SHALL be met as part of the definition of the extension.
       Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or
       DomainResource (including cannot change the meaning of modifierExtension itself)."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,

       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be

       clearly distinguished from the vast majority of extensions which can be safely
       ignored.  This promotes interoperability by eliminating the need for implementers
       to prohibit the presence of extensions. For further information, see the [definition
       of modifier extensions](extensibility.html#modifierExtension)."/> 
      <alias value="extensions"/> 
      <alias value="user content"/> 
      <alias value="modifiers"/> 
      <min value="0"/> 
      <max value="*"/> 
      <base> 
        <path value="BackboneElement.modifierExtension"/> 
        <min value="0"/> 
        <max value="*"/> 
      </base> 
      <type> 
        <code value="Extension"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <constraint> 
        <key value="ext-1"/> 
        <severity value="error"/> 
        <human value="Must have either extensions or value[x], not both"/> 
        <expression value="extension.exists() != value.exists()"/> 
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> 
      </constraint> 
      <isModifier value="true"/> 
      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the

       element that contains them"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="rim"/> 
        <map value="N/A"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.webLocation.classifier">
      <path value="ResearchStudy.webLocation.classifier"/> 
      <short value="registry-page|recruitment-page|contact-page"/> 
      <definition value="Describes the nature of the location being specified."/> 
      <min value="0"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.webLocation.classifier"/> 
        <min value="0"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value=" ArtifactUrlClassifier"/> 
        </extension> 
        <strength value="example"/> 
        <description value="defn."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/artifact-url-classifier"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.webLocation.url">
      <path value="ResearchStudy.webLocation.url"/> 
      <short value="The location address"/> 
      <definition value="The location address."/> 
      <min value="1"/> 
      <max value="1"/> 
      <base> 
        <path value="ResearchStudy.webLocation.url"/> 
        <min value="1"/> 
        <max value="1"/> 
      </base> 
      <type> 
        <code value="uri"/> 
      </type> 
      <constraint> 
        <key value="ele-1"/> 
        <severity value="error"/> 
        <human value="All FHIR elements must have a @value or children"/> 
        <expression value="hasValue() or (children().count() &gt; id.count())"/> 
        <xpath value="@value|f:*|h:div"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/> 
      </constraint> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
  </snapshot> 
  <differential> 
    <element id="ResearchStudy">
      <path value="ResearchStudy"/> 
      <short value="Investigation to increase healthcare-related patient-independent knowledge"/> 
      A process where a researcher or organization plans and then executes a series of steps
       intended to increase the field of healthcare-related knowledge.  This includes studies
       of safety, efficacy, comparative effectiveness and other information about medications,
       devices, therapies and other interventional and investigative techniques.  A ResearchStudy
       involves the gathering of information about human or animal subjects.

      <definition value="A scientific study of nature that sometimes includes processes involved in health
       and disease. For example, clinical trials are research studies that involve people.
       These studies may be related to new ways to screen, prevent, diagnose, and treat
       disease. They may also study certain outcomes and certain groups of people by looking
       at data collected in the past or future."/> 

      <comment value="Need to make sure we encompass public health studies."/> 
      <alias value="Clinical Trial"/> 
      <alias value="Study"/> 
      <min value="0"/> 
      <max value="*"/> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion"/> 
      </mapping> 
      <mapping> 
        <identity value="v2"/> 
        <map value="OBX"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value="Observation[classCode=CLNTRL, moodCode=EVN]"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="clinical.diagnostics"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.url">
      <path value="ResearchStudy.url"/> 
      <short value="Canonical identifier for this study resource"/> 
      <definition value="Canonical identifier for this study resource, represented as a globally unique
       URI."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="uri"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.identifier">
      <path value="ResearchStudy.identifier"/> 
      <short value="Business Identifier for study"/> 
      <definition value="Identifiers assigned to this research study by the sponsor or other systems."/> 
      Allows identification of the research study as it is known by various participating systems
       and in a way that remains consistent across servers.

      <requirements value="Allows identification of the research study as it is known by various participating
       systems and in a way that remains consistent across servers."/> 

      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="Identifier"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Organization's Unique Protocol ID; Secondary IDs"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.identifier"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        No BRIDG mapping (although there is  DocumentVersion.identifier &gt; StudyProtocolDocumentVersion,
         this is arguably a different semantic)

        <map value="No BRIDG mapping (although there is  DocumentVersion.identifier &gt; StudyProtocolDocumentVer
        sion, this is arguably a different semantic)"/> 

      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value=".identifier"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.version">
      <path value="ResearchStudy.version"/> 
      <short value="The business version for the study record"/> 
      <definition value="The business version for the study record."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="string"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.name">
      <path value="ResearchStudy.name"/> 
      <short value="Name for this study (computer friendly)"/> 
      <definition value="Name for this study (computer friendly)."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="string"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.title">
      <path value="ResearchStudy.title"/> 
      
      

      <short value="Human readable name of the study"/> 
      <definition value="The human readable name of the research study."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="string"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Brief Title"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        No BRIDG mapping (although there is  StudyProtocolDocumentVersionPublicTitle this is arguably
         a different semantic: title of a document vs title of a research study)

        <map value="No BRIDG mapping (although there is  StudyProtocolDocumentVersionPublicTitle this
         is arguably a different semantic: title of a document vs title of a research study)"/> 

      </mapping> 
    </element> 
    <element id="ResearchStudy.label">
      <path value="ResearchStudy.label"/> 
      <short value="Additional names for the study"/> 
      <definition value="Additional names for the study."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.label.type">
      <path value="ResearchStudy.label.type"/> 
      <short value="primary | official | scientific | plain-language | subtitle | short-title | acronym
       | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid"/> 
      <definition value="Kind of name."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="TitleType"/> 
        </extension> 
        <strength value="extensible"/> 
        <description value="desc."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/title-type"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.label.value">
      <path value="ResearchStudy.label.value"/> 
      <short value="The name"/> 
      <definition value="The name."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="string"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.protocol">
      <path value="ResearchStudy.protocol"/> 
      <short value="Steps followed in executing study"/> 
      <definition value="The set of steps expected to be performed as part of the execution of the study."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Interventions; Arm/Intervention Cross-Reference"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyProtocolDocumentVersionPublicTitle.name"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value=".outboundRelationship[typeCode=DEFN].target"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.partOf">
      <path value="ResearchStudy.partOf"/> 
      <short value="Part of larger study"/> 
      <definition value="A larger research study of which this particular study is a component or step."/> 
      Allows breaking a study into components (e.g. by study site) each with their own PI, status,
       enrollment, etc.

      <requirements value="Allows breaking a study into components (e.g. by study site) each with their own
       PI, status, enrollment, etc."/> 

      <alias value="container"/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="CompanionStudyRelationship"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value=".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.relatedArtifact">
      <path value="ResearchStudy.relatedArtifact"/> 
      <short value="References and dependencies"/> 
      <definition value="Citations, references and other related documents."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="RelatedArtifact"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Citations, Links, Available Study Data/Documents"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyProtocolDocument, StudyProtocolDocumentVersion"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.date">
      <path value="ResearchStudy.date"/> 
      <short value="Date the resource last changed"/> 
      <definition value="The date (and optionally time) when the ResearchStudy Resource was published. The
       date must change when the business version changes and it must change if the status
       code changes. In addition, it should change when the substantive content of the
       ResearchStudy Resource changes."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="dateTime"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.status">
      <path value="ResearchStudy.status"/> 
      active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervent
      ion | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-acc
      rual-and-intervention | withdrawn
      

      <short value="draft | active | retired | unknown"/> 
      <definition value="The publication state of the resource (not of the study)."/> 
      <min value="1"/> 
      <max value="1"/> 
      <type> 
        <code value="code"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="true"/> 
      This element is labeled as a modifier because it is a status element that contains status
       entered-in-error which means that the resource should not be treated as valid

      <isModifierReason value="This element is labeled as a modifier because it is a status element that contains
       status entered-in-error which means that the resource should not be treated as
       valid"/> 

      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          

          <valueString value="PublicationStatus"/> 
        </extension> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
          <valueBoolean value="true"/> 
        </extension> 
        <strength value="required"/> 
        
        

        <description value="Codes that convey the current publication status of the research study resource."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/publication-status|5.0.0-ballot"/> 
      </binding> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.status"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyOverallStatus.code"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value=".status"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.primaryPurposeType">
      <path value="ResearchStudy.primaryPurposeType"/> 
      <short value="treatment | prevention | diagnostic | supportive-care | screening | health-services-research
       | basic-science | device-feasibility"/> 
      The type of study based upon the intent of the study's activities. A classification of
       the intent of the study.

      <definition value="The type of study based upon the intent of the study activities. A classification
       of the intent of the study."/> 

      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyPrimaryPurposeType"/> 
        </extension> 
        <strength value="extensible"/> 
        <description value="Codes for the main intent of the study."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"/> 
      </binding> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyProtocolVersion.primaryPurposeTypeCode"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.phase">
      <path value="ResearchStudy.phase"/> 
      <short value="n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3
       | phase-4"/> 
      The stage in the progression of a therapy from initial experimental use in humans in clinical
       trials to post-market evaluation.

      <definition value="The stage in the progression of a therapy from initial experimental use in humans
       in clinical trials to post-market evaluation."/> 

      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyPhase"/> 
        </extension> 
        <strength value="example"/> 
        Codes for the stage in the progression of a therapy from initial experimental use in humans
         in clinical trials to post-market evaluation.

        <description value="Codes for the stage in the progression of a therapy from initial experimental use
         in humans in clinical trials to post-market evaluation."/> 

        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-phase"/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Study Phase"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyProtocolVersion.phaseCode"/> 
      </mapping> 
    </element> 
    
      
      
      Codes categorizing the type of study such as investigational vs. observational, type of
       blinding, type of randomization, safety vs. efficacy, etc.

    <element id="ResearchStudy.studyDesign">
      <path value="ResearchStudy.studyDesign"/> 
      <short value="Classifications of the study design characteristics"/> 
      <definition value="Codes categorizing the type of study such as investigational vs. observational,
       type of blinding, type of randomization, safety vs. efficacy, etc."/> 

      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          

          <valueString value="StudyDesign"/> 
        </extension> 
        
        Codes that describe the type of research study.  E.g. Study phase, Interventional/Observational,
         blinding type, etc.

        <strength value="preferred"/> 
        <description value="This is a set of terms for study design characteristics."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/study-design"/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification;
         Observational Study Model; Time Perspective; Biospecimen Retention"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyP
        rotocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.
        controlTypeCode

        <map value="InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode;
         InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode;
         InterventionalStudyProtocol.controlTypeCode"/> 

      </mapping> 
    </element> 
    <element id="ResearchStudy.focus">
      <path value="ResearchStudy.focus"/> 
      <short value="Drugs, devices, etc. under study"/> 
      <definition value="The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions
       that the study is seeking to gain more information about."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.focus.productCode">
      <path value="ResearchStudy.focus.productCode"/> 
      <short value="Identification of product under study"/> 
      <definition value="Identification of product under study.  This may be any combination of code and/or
       name."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyFocus"/> 
        </extension> 
        <strength value="example"/> 
        <description value="Codes for medications, devices and other interventions."/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Focus of Study"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.what[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="InterventionalStudyProtocol.interventionTypeCode"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.focus.focusType">
      <path value="ResearchStudy.focus.focusType"/> 
      <short value="medication | device | intervention | factor"/> 
      <definition value="Indicates whether the focus is a medication, a device, a procedure, a specific
       factor or some other intervention or characteristic."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyFocusType"/> 
        </extension> 
        <strength value="extensible"/> 
        <description value="defn."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-focus-type"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.focus.factor">
      <path value="ResearchStudy.focus.factor"/> 
      <short value="An independent variable manipulated by the experimentalist"/> 
      <definition value="A factor corresponds to an independent variable manipulated by the experimentalist

       with the intention to affect biological systems in a way that can be measured by
       an assay."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="markdown"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.condition">
      <path value="ResearchStudy.condition"/> 
      <short value="Condition being studied"/> 
      The condition that is the focus of the study.  For example, In a study to examine risk
       factors for Lupus, might have as an inclusion criterion &quot;healthy volunteer&quot;,

      <definition value="The condition that is the focus of the study.  For example, In a study to examine
       risk factors for Lupus, might have as an inclusion criterion &quot;healthy volunteer&quot;,

       but the target condition code would be a Lupus SNOMED code."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ConditionCode"/> 
        </extension> 
        <strength value="example"/> 
        <description value="Identification of the condition or diagnosis."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/condition-code"/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Conditions"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.what[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyCondition.code"/> 
      </mapping> 
    </element> 
    
      
      
      
      
      
      
        
      
      
      
      
      
        
        Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact &amp;
         Backup (if Study tied to only one location); Investigators
      
      
        
        PointOfContact &gt; Project &gt; Research Project &gt; Study &gt; StudyProtocol &gt; StudyProtocolVe
        rsion
      
    
    
      
      
      
      
      
      
        
      
      
      
      
      
        
        
      
      
        
        
      
    

    <element id="ResearchStudy.keyword">
      <path value="ResearchStudy.keyword"/> 
      <short value="Used to search for the study"/> 
      <definition value="Key terms to aid in searching for or filtering the study."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyKeyword"/> 
        </extension> 
        <strength value="example"/> 
        <description value="Words associated with the study that may be useful in discovery."/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Keywords"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="DocumentVersion.keywordCode; DocumentVersion.keywordText"/> 
      </mapping> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.region">
      <path value="ResearchStudy.region"/> 
      <short value="Geographic area for the study"/> 
      <definition value="A country, state or other area where the study is taking place rather than its
       precise geographic location or address."/> 

      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="Jurisdiction"/> 
        </extension> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
          <valueBoolean value="true"/> 
        </extension> 
        <strength value="extensible"/> 
        <description value="Countries and regions within which this artifact is targeted for use."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/> 
      </binding> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyProtocolVersion.participatingLocationCode"/> 
      </mapping> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.descriptionSummary">
      <path value="ResearchStudy.descriptionSummary"/> 
      <short value="Brief text explaining the study"/> 
      <definition value="A brief text for explaining the study."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="markdown"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      
        
        
      
      
        
        
      

    </element> 
    
      
      
      Reference to a Group that defines the criteria for and quantity of subjects participating
       in the study.  E.g. &quot; 200 female Europeans between the ages of 20 and 45 with early
       onset diabetes&quot;.
      The Group referenced should not generally enumerate specific subjects.  Subjects will
       be linked to the study using the ResearchSubject resource.
      

    <element id="ResearchStudy.description">
      <path value="ResearchStudy.description"/> 
      <short value="Detailed narrative of the study"/> 
      <definition value="A detailed and human-readable narrative of the study. E.g., study abstract."/> 
      <min value="0"/> 
      

      <max value="1"/> 
      <type> 
        
        

        <code value="markdown"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      

      <isSummary value="false"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        Enrollment; Number of Groups/Cohorts (= number of &quot;enrollment&quot; instances); Groups
         (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility
         (Group criteria)
      
      
        
        

        <map value="Detailed Description"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        
      
      
        
        
      
      
        
        

        <map value="StudyProtocolDocumentVersion.publicDescription"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.period">
      <path value="ResearchStudy.period"/> 
      <short value="When the study began and ended"/> 
      Identifies the start date and the expected (or actual, depending on status) end date for
       the study.

      <definition value="Identifies the start date and the expected (or actual, depending on status) end
       date for the study."/> 

      <alias value="timing"/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="Period"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Study Start Date (start); Study Completion Date (end)"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.done[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value=".effectiveTime"/> 
      </mapping> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.site">
      <path value="ResearchStudy.site"/> 
      <short value="Facility where study activities are conducted"/> 
      <definition value="A facility in which study activities are conducted."/> 
      <min value="0"/> 
      

      <max value="*"/> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        

        <map value="Facility"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        

        <map value="FiveWs.where[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        

        <map value="PlannedStudySite; StudySite"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.note">
      <path value="ResearchStudy.note"/> 
      <short value="Comments made about the study"/> 
      <definition value="Comments made about the study by the performer, subject or other participants."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="Annotation"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="No BRIDG mapping"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        

        <map value=".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"/> 
      </mapping> 
    </element> 
    
      
      
      A researcher in a study who oversees multiple aspects of the study, such as concept development,
       protocol writing, protocol submission for IRB approval, participant recruitment, informed
       consent, data collection, analysis, interpretation and presentation.

    <element id="ResearchStudy.classifier">
      <path value="ResearchStudy.classifier"/> 
      <short value="Classification for the study"/> 
      <definition value="Additional grouping mechanism or categorization of a research study. Example: FDA
       regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement),
       IRB-exempt, etc. Implementation Note: do not use the classifier element to support
       existing semantics that are already supported thru explicit elements in the resource."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyClassifiers"/> 
        </extension> 
        <strength value="example"/> 
        <description value="desc."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-classifiers"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.associatedParty">
      <path value="ResearchStudy.associatedParty"/> 
      <short value="Sponsors, collaborators, and other parties"/> 
      <definition value="Sponsors, collaborators, and other parties."/> 
      <comment value="For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided."/> 
      <requirements value="While there are explicit attributes for a Sponsor and a PrincipalInvestigator many

       trial record a range of other organizations and individuals in key roles."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.associatedParty.name">
      <path value="ResearchStudy.associatedParty.name"/> 
      <short value="Name of associated party"/> 
      <definition value="Name of associated party."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="string"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.associatedParty.role">
      <path value="ResearchStudy.associatedParty.role"/> 
      <short value="sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator

       | funding-source | general-contact | recruitment-contact | sub-investigator | study-director
       | study-chair"/> 
      <definition value="Type of association."/> 
      <min value="1"/> 
      <max value="1"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyPartyRole"/> 
        </extension> 
        <strength value="extensible"/> 
        <description value="desc."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-party-role"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.associatedParty.period">
      <path value="ResearchStudy.associatedParty.period"/> 
      <short value="When active in the role"/> 
      <definition value="Identifies the start date and the end date of the associated party in the role."/> 
      <comment value="The cardinality is 0..* due to the fact that an associated party may be intermittently

       active in a given role over multiple time periods."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="Period"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.associatedParty.classifier">
      <path value="ResearchStudy.associatedParty.classifier"/> 
      <short value="nih | fda | government | nonprofit | academic | industry"/> 
      <definition value="A categorization other than role for the associated party."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyPartyOrganizationType"/> 
        </extension> 
        <strength value="example"/> 
        <description value="A characterization or type of the entity."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-party-org-type"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.associatedParty.party">
      <path value="ResearchStudy.associatedParty.party"/> 
      <short value="Individual or organization associated with study (use practitionerRole to specify

       their organisation)"/> 
      <definition value="Individual or organization associated with study (use practitionerRole to specify

       their organisation)."/> 
      <comment value="Suggestions of a better attribute name are appreciated"/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      
      
        
        
      
      
        
        
      
      
        
        
      

      <isSummary value="false"/> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.progressStatus">
      <path value="ResearchStudy.progressStatus"/> 
      <short value="Status of study with time for that status"/> 
      <definition value="Status of study with time for that status."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        
        

        <code value="BackboneElement"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      
      
        
        
      
      
        
        
      
      
        
        
      

      <isSummary value="false"/> 
    </element> 
    
      
      accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-close
      d-per-study-design

    <element id="ResearchStudy.progressStatus.state">
      <path value="ResearchStudy.progressStatus.state"/> 
      <short value="Label for status or state (e.g. recruitment status)"/> 
      <definition value="Label for status or state (e.g. recruitment status)."/> 
      <min value="1"/> 
      <max value="1"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyStudyStatus"/> 
        </extension> 
        <strength value="extensible"/> 
        <description value="defn."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-status"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.progressStatus.actual">
      <path value="ResearchStudy.progressStatus.actual"/> 
      <short value="Actual if true else anticipated"/> 
      <definition value="An indication of whether or not the date is a known date when the state changed
       or will change. A value of true indicates a known date. A value of false indicates
       an estimated date."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="boolean"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.progressStatus.period">
      <path value="ResearchStudy.progressStatus.period"/> 
      <short value="Date range"/> 
      <definition value="Date range."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="Period"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.whyStopped">
      <path value="ResearchStudy.whyStopped"/> 
      <short value="accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress

       | temporarily-closed-per-study-design"/> 

      <definition value="A description and/or code explaining the premature termination of the study."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyReasonStopped"/> 
        </extension> 
        <strength value="example"/> 
        <description value="Codes for why the study ended prematurely."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-reason-stopped"/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Why Study Stopped"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.why[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyOverallStatus.studyStoppedReasonCode"/> 
      </mapping> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.recruitment">
      <path value="ResearchStudy.recruitment"/> 
      <short value="Target or actual group of participants enrolled in study"/> 
      <definition value="Target or actual group of participants enrolled in study."/> 
      <min value="0"/> 
      

      <max value="1"/> 
      <type> 
        

        <code value="BackboneElement"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Enrollment; Number of Groups/Cohorts (= number of &quot;enrollment&quot; instances);
         Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description);
         Eligibility (Group criteria)"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.subject[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="InterventionalStudyProtocol.interventionGroupQuantity"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        <map value=".participation[typeCode=SBJ].role"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.subject"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.recruitment.targetNumber">
      <path value="ResearchStudy.recruitment.targetNumber"/> 
      <short value="Estimated total number of participants to be enrolled"/> 
      <definition value="Estimated total number of participants to be enrolled."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="unsignedInt"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.recruitment.actualNumber">
      <path value="ResearchStudy.recruitment.actualNumber"/> 
      <short value="Actual total number of participants enrolled in study"/> 
      <definition value="Actual total number of participants enrolled in study."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="unsignedInt"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.recruitment.eligibility">
      <path value="ResearchStudy.recruitment.eligibility"/> 
      <short value="Inclusion and exclusion criteria"/> 
      <definition value="Inclusion and exclusion criteria."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/EvidenceVariable"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.recruitment.actualGroup">
      <path value="ResearchStudy.recruitment.actualGroup"/> 
      <short value="Group of participants who were enrolled in study"/> 
      <definition value="Group of participants who were enrolled in study."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Enrollment; Number of Groups/Cohorts (= number of &quot;enrollment&quot; instances);
         Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description);
         Eligibility (Group criteria)"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.subject[x]"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        

        <map value="InterventionalStudyProtocol.interventionGroupQuantity"/> 
      </mapping> 
      <mapping> 
        <identity value="rim"/> 
        

        <map value=".participation[typeCode=SBJ].role"/> 
      </mapping> 
      <mapping> 
        <identity value="w5"/> 
        <map value="FiveWs.subject"/> 
      </mapping> 
    </element> 
    
      

    <element id="ResearchStudy.comparisonGroup">
      <path value="ResearchStudy.comparisonGroup"/> 
      <short value="Defined path through the study for a subject"/> 
      Describes an expected sequence of events for one of the participants of a study.  E.g.
       Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.

      <definition value="Describes an expected sequence of events for one of the participants of a study.
        E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up."/> 
      <comment value="In many clinical trials this is refered to as the ARM of the study, but such a

       term is not used in other sorts of trials even when there is a comparison between
       two or more groups."/> 
      <alias value="arm"/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Arms"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="Arm"/> 
      </mapping> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.comparisonGroup.identifier[x]">
      <path value="ResearchStudy.comparisonGroup.identifier[x]"/> 
      <short value="Allows the comparisonGroup for the study and the comparisonGroup for the subject
       to be linked easily"/> 
      <definition value="Allows the comparisonGroup for the study and the comparisonGroup for the subject

       to be linked easily."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="uri"/> 
      </type> 
      <type> 
        <code value="Identifier"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.comparisonGroup.name">
      <path value="ResearchStudy.comparisonGroup.name"/> 
      <short value="Label for study comparisonGroup"/> 
      <definition value="Unique, human-readable label for this comparisonGroup of the study."/> 
      <min value="1"/> 
      <max value="1"/> 
      <type> 
        <code value="string"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Arm Label"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="Arm.name"/> 
      </mapping> 
    </element> 
    
      
      
      

    <element id="ResearchStudy.comparisonGroup.type">
      <path value="ResearchStudy.comparisonGroup.type"/> 
      <short value="Categorization of study comparisonGroup"/> 
      <definition value="Categorization of study comparisonGroup, e.g. experimental, active comparator,
       placebo comparater."/> 

      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyArmType"/> 
        </extension> 
        <strength value="extensible"/> 
        <description value="desc."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-arm-type"/> 
      </binding> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Arm Type"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="Arm.typeCode"/> 
      </mapping> 
    </element> 
    
      

    <element id="ResearchStudy.comparisonGroup.description">
      <path value="ResearchStudy.comparisonGroup.description"/> 
      <short value="Short explanation of study path"/> 
      A succinct description of the path through the study that would be followed by a subject
       adhering to this arm.

      <definition value="A succinct description of the path through the study that would be followed by
       a subject adhering to this comparisonGroup."/> 

      <min value="0"/> 
      <max value="1"/> 
      <type> 
        

        <code value="markdown"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="clinicaltrials-gov"/> 
        <map value="Arm Description"/> 
      </mapping> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="Arm.description"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.comparisonGroup.intendedExposure">
      <path value="ResearchStudy.comparisonGroup.intendedExposure"/> 
      <short value="Interventions or exposures in this comparisonGroup or cohort"/> 
      <definition value="Interventions or exposures in this comparisonGroup or cohort."/> 
      <requirements value="this is necessary for ClinicalTrials.gov use which relates  1 to many interventions
       to comparisonGroups (aka arms)"/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/EvidenceVariable"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.comparisonGroup.observedGroup">
      <path value="ResearchStudy.comparisonGroup.observedGroup"/> 
      <short value="Group of participants who were enrolled in study comparisonGroup"/> 
      <definition value="Group of participants who were enrolled in study comparisonGroup."/> 
      <requirements value="This is necessary to relate comparisonGroups to actual groups"/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.objective">
      <path value="ResearchStudy.objective"/> 
      <short value="A goal for the study"/> 
      A goal that the study is aiming to achieve in terms of a scientific question to be answered
       by the analysis of data collected during the study.

      <definition value="A goal that the study is aiming to achieve in terms of a scientific question to
       be answered by the analysis of data collected during the study."/> 

      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyObjective"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.objective.name">
      <path value="ResearchStudy.objective.name"/> 
      <short value="Label for the objective"/> 
      <definition value="Unique, human-readable label for this objective of the study."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="string"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="No BRIDG mapping (BRIDG has a description, but not a name)"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.objective.type">
      <path value="ResearchStudy.objective.type"/> 
      <short value="primary | secondary | exploratory"/> 
      <definition value="The kind of study objective."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyObjectiveType"/> 
        </extension> 
        <strength value="preferred"/> 
        <description value="Codes for the kind of study objective."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-objective-type"/> 
      </binding> 
      <mapping> 
        <identity value="BRIDG5.1"/> 
        <map value="StudyObjective.typeCode"/> 
      </mapping> 
    </element> 
    <element id="ResearchStudy.objective.description">
      <path value="ResearchStudy.objective.description"/> 
      <short value="Description of the objective"/> 
      <definition value="Free text description of the objective of the study.  This is what the study is
       trying to achieve rather than how it is going to achieve it (see ResearchStudy.description)."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="markdown"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.outcomeMeasure">
      <path value="ResearchStudy.outcomeMeasure"/> 
      <short value="An outcome or planned variable to measure during the study"/> 
      <definition value="An outcome or planned variable to measure during the study."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.outcomeMeasure.name">
      <path value="ResearchStudy.outcomeMeasure.name"/> 
      <short value="Label for the outcome"/> 
      <definition value="Label for the outcome."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="string"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.outcomeMeasure.type">
      <path value="ResearchStudy.outcomeMeasure.type"/> 
      <short value="primary | secondary | exploratory"/> 
      <definition value="The parameter or characteristic being assessed as one of the values by which the

       study is assessed."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyObjectiveType"/> 
        </extension> 
        <strength value="preferred"/> 
        <description value="defn."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/research-study-objective-type"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.outcomeMeasure.description">
      <path value="ResearchStudy.outcomeMeasure.description"/> 
      <short value="Description of the outcome"/> 
      <definition value="Description of the outcome."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="markdown"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.outcomeMeasure.reference">
      <path value="ResearchStudy.outcomeMeasure.reference"/> 
      <short value="Structured outcome definition"/> 
      <definition value="Structured outcome definition."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/EvidenceVariable"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.result">
      <path value="ResearchStudy.result"/> 
      <short value="Link to results generated during the study"/> 
      <definition value="Link to one or more sets of results generated by the study.  Could also link to

       a research registry holding the results such as ClinicalTrials.gov."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="Reference"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/EvidenceReport"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Citation"/> 
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/DiagnosticReport"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="true"/> 
    </element> 
    <element id="ResearchStudy.webLocation">
      <path value="ResearchStudy.webLocation"/> 
      <short value="Archive location for the study"/> 
      <definition value="A general storage or archive location for the study.  This may contain an assortment

       of content which is not specified in advance."/> 
      <min value="0"/> 
      <max value="*"/> 
      <type> 
        <code value="BackboneElement"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
    <element id="ResearchStudy.webLocation.classifier">
      <path value="ResearchStudy.webLocation.classifier"/> 
      <short value="registry-page|recruitment-page|contact-page"/> 
      <definition value="Describes the nature of the location being specified."/> 
      <min value="0"/> 
      <max value="1"/> 
      <type> 
        <code value="CodeableConcept"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
      <binding> 
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value=" ArtifactUrlClassifier"/> 
        </extension> 
        <strength value="example"/> 
        <description value="defn."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/artifact-url-classifier"/> 
      </binding> 
    </element> 
    <element id="ResearchStudy.webLocation.url">
      <path value="ResearchStudy.webLocation.url"/> 
      <short value="The location address"/> 
      <definition value="The location address."/> 
      <min value="1"/> 
      <max value="1"/> 
      <type> 
        <code value="uri"/> 
      </type> 
      <mustSupport value="false"/> 
      <isModifier value="false"/> 
      <isSummary value="false"/> 
    </element> 
  </differential> 


</

StructureDefinition

>



Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.