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8.22 Resource ResearchStudy - Content

Biomedical Research and Regulation Work Group Maturity Level : 1 0   Trial Use Security Category : Business Compartments : Practitioner

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. subjects or stability data about drug products or drug substances.

8.22.1 Scope and Usage

Trial-Use Note: In terms of scope and usage, the BR and RR workgroup wish to draw the attention of reviewers and implementers to the following issue:

  1. This is a major restructuring of the resource. We are seeking input from the implementation community on the appropriateness of these changes

This resource is an definition resource from a FHIR workflow perspective - see Workflow .

A research study is a scientific way to improve or develop new methods of health care. Studies are designed to answer specific questions on how to prevent, diagnose, or treat diseases and disorders. The ResearchStudy resource describes essential information about the study, including the purpose, objective, sponsor, investigator, therapy, condition being studied, schedule of activities, and other key items.

Uses for the ResearchStudy resource include:

  • Registering a clinical trial in trial registry such as clinicaltrials.gov
  • Communicating study protocol information between study stakeholders
  • Supporting study set up of sites, forms
  • Grouping Observation resources by study
  • Setting up a Schedule of Activities for the study and its subjects

8.22.1.1 Extensions

ResearchStudy is aimed at all forms of studies. For some study types specific extensions have been defined

Extension: RelatesTo

Many clinical studies have a component sub-study and the partOf attribute should be used for this. There may also be documents such as a PDF of the protocol or consent forms and these should be linked using relatedAretfact. However there may be more complex relations to other studies people organizations or artefacts and the RelatesTo extension is provided to record these.

Extension: SiteRecruitment

Some studies need to find sites according to specific criteria - for example site has a freezer capable of very low temperatures and a centrifuge.

8.22.2 References

This resource is referenced by UsageContext , AdverseEvent , MedicinalProduct MedicinalProductDefinition , RegulatedAuthorization , itself and ResearchSubject .

This resource does not implement any patterns.

8.22.2 8.22.3 Resource Content

Structure

Name Flags Card. Type Description & Constraints doco
. . ResearchStudy TU DomainResource Investigation to increase healthcare-related patient-independent knowledge
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . url 0..1 uri Canonical identifier for this study resource
... identifier Σ 0..* Identifier Business Identifier for study
. . . version 0..1 string Business identifier for the study record
. . . name 0..1 string Name for this study (computer friendly)
... title Σ 0..1 string Name for this study (for computers)
. . . label 0..* BackboneElement Additional names for the study
.... type 0..1 CodeableConcept short | public | scientific
ResearchStudyTitleType ( Extensible )
.... value 0..1 string The name
. . . protocol Σ 0..* Reference ( PlanDefinition ) Steps followed in executing study
. . . partOf Σ 0..* Reference ( ResearchStudy ) Part of larger study
. . . relatedArtifact 0..* RelatedArtifact References and dependencies
... date 0..1 dateTime Date the resource last changed
. . . status ?! Σ 1..1 code active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review draft | temporarily-closed-to-accrual active | temporarily-closed-to-accrual-and-intervention retired | withdrawn unknown
ResearchStudyStatus PublicationStatus ( Required )
. . . primaryPurposeType Σ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
ResearchStudyPrimaryPurposeType ( Extensible )
. . . phase Σ 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
ResearchStudyPhase ( Example )
. . . category Σ 0..* CodeableConcept Classifications for the study
ResearchStudyCategory ( Example )
. . . focus Σ 0..* CodeableConcept BackboneElement Drugs, devices, etc. under study
. . . . condition productCode Σ 0..* 0..1 CodeableConcept Condition being studied Identification of product under study
Condition/Problem/Diagnosis Codes ResearchStudyFocus ( Example )
. . . . contact focusType Σ 0..* ContactDetail CodeableConcept Contact details for the study medication | device | intervention | factor
ResearchStudyFocusType ( Extensible )
. . relatedArtifact . . factor 0..* 0..1 RelatedArtifact markdown References and dependencies An independent variable manipulated by the experimentalist
. . . keyword condition Σ 0..* CodeableConcept Condition being studied
Condition/Problem/Diagnosis Codes ( Example )
... keyword Σ 0..* CodeableConcept Used to search for the study
ResearchStudyKeyword ( Example )
. . . location Σ 0..* CodeableConcept Geographic region(s) for study
Jurisdiction ( Extensible )
. . . descriptionSummary 0..1 markdown A brief summary of the study description
. . . description 0..1 markdown What this is study doing
. . enrollment . period Σ 0..* 0..1 Reference ( Group Period ) Inclusion & exclusion criteria When the study began and ended
. . . period contact Σ 0..1 0..* Period ContactDetail When Contact details for the study began and ended
. . . sponsor Σ 0..1 Reference ( Organization ) Organization that initiates and is legally responsible for the study
. . . principalInvestigator Σ 0..1 Reference ( Practitioner | PractitionerRole ) Researcher who oversees multiple aspects of the study
. . . site Σ 0..* Reference ( Location | ResearchStudy | Organization ) Facility where study activities are conducted
. . . reasonStopped note 0..* Annotation Comments made about the study
... classification 0..* BackboneElement Classification for the study
.... type 0..1 CodeableConcept phase | category | keyword
ResearchStudyCLassificationType ( Extensible )
.... classifier 0..* CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
ResearchStudyClassificationClassifier ( Extensible )
... associatedParty 0..* BackboneElement Sponsors, collaborators, and other parties
.... name 0..1 string Name of associated party
.... role 1..1 CodeableConcept sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair
ResearchStudyPartyType ( Extensible )
.... classifier 0..* CodeableConcept nih | fda
ResearchStudyPartyOrganizationType ( Extensible )
.... party 0..1 Reference ( Practitioner | PractitionerRole | Organization ) Individual or organization associated with study (use practitionerRole to specify their organisation)
... currentState 0..* CodeableConcept active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
ResearchStudyStatus ( Extensible )
... statusDate 0..* BackboneElement Status of study with time for that status
.... activity 1..1 CodeableConcept Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting
ResearchStudyStatusActivity ( Extensible )
.... actual 0..1 boolean Actual if true else anticipated
.... period 1..1 Period Date range
... whyStopped Σ 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
ResearchStudyReasonStopped ( Example )
. . . recruitment Σ 0..1 BackboneElement Target or actual group of participants enrolled in study
. . . note . targetNumber 0..1 unsignedInt Estimated total number of participants to be enrolled
.... actualNumber 0..* 0..1 Annotation unsignedInt Comments made about the Actual total number of participants enrolled in study
. . . . eligibility 0..1 Reference ( Group ) Inclusion and exclusion criteria
. . . . actualGroup Σ 0..1 Reference ( Group ) Group of participants who were enrolled in study
. . . arm comparisonGroup 0..* BackboneElement Defined path through the study for a subject
. . . name . identifier[x] 1..1 0..1 Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
..... identifierUri uri
..... identifierIdentifier Identifier
. . . . name 1..1 string Label for study arm comparisonGroup
. . . . type 0..1 CodeableConcept Categorization of study arm comparisonGroup
ResearchStudyArmType ( Extensible )
. . . . description 0..1 string markdown Short explanation of study path
. . . . intendedExposure 0..* Reference ( EvidenceVariable ) Interventions or exposures in this comparisonGroup or cohort
. . . . observedGroup 0..1 Reference ( Group ) Group of participants who were enrolled in study comparisonGroup
... objective 0..* BackboneElement A goal for the study
. . . . name 0..1 string Label for the objective
. . . . type 0..1 CodeableConcept primary | secondary | exploratory
ResearchStudyObjectiveType ( Preferred )
.... description 0..1 markdown Description of the objective
... outcomeMeasure 0..* BackboneElement An outcome or planned variable to measure during the study
.... name 0..1 string Label for the outcome
.... type 0..* CodeableConcept primary | secondary | exploratory
ResearchStudyObjectiveType ( Preferred )
. . . . description 0..1 markdown Description of the outcome
.... reference 0..1 Reference ( EvidenceVariable ) Structured outcome definition
... result Σ 0..* Reference ( EvidenceReport | Citation | DiagnosticReport ) Link to results generated during the study
... webLocation 0..* BackboneElement Archive location for the study
.... type 0..1 CodeableConcept registry-page|recruitment-page|contact-page
ResearchStudyUrlType ( Extensible )
.... url 1..1 uri The location address

doco Documentation for this format

UML Diagram ( Legend )

ResearchStudy ( DomainResource ) Canonical identifier for this study resource, represented as a globally unique URI url : uri [0..1] Identifiers assigned to this research study by the sponsor or other systems identifier : Identifier [0..*] Business identifier for the study record version : string [0..1] Name for this study (computer friendly) name : string [0..1] A short, descriptive user-friendly label for the study particularly for compouter use title : string [0..1] The set of steps expected to be performed as part of the execution of the study protocol : Reference [0..*] « PlanDefinition » A larger research study of which this particular study is a component or step partOf : Reference [0..*] « ResearchStudy » Citations, references and other related documents relatedArtifact : RelatedArtifact [0..*] Date the resource last changed date : dateTime [0..1] The current publication state of the study resource (not of the study) (this element modifies the meaning of other elements) status : code [1..1] « Codes that convey the current status of the research study. null (Strength=Required) ResearchStudyStatus PublicationStatus ! » The type of study based upon the intent of the study's study activities. A classification of the intent of the study primaryPurposeType : CodeableConcept [0..1] « Codes for the main intent of the study. null (Strength=Extensible) ResearchStudyPrimaryPurposeTy... + » The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation phase : CodeableConcept [0..1] « Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. null (Strength=Example) ResearchStudyPhase ?? » Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc category : CodeableConcept [0..*] « The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about null (Strength=Example) focus : CodeableConcept [0..*] ResearchStudyCategory?? » 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 "healthy volunteer", but the target condition code would be a Lupus SNOMED code condition : CodeableConcept [0..*] « Identification of the condition or diagnosis. null (Strength=Example) Condition/Problem/DiagnosisCo... ?? » Contact details to assist a user in learning more about or engaging with the study contact : ContactDetail [0..*] Citations, references and other related documents relatedArtifact : RelatedArtifact [0..*] Key terms to aid in searching for or filtering the study keyword : CodeableConcept [0..*] « null (Strength=Example) ResearchStudyKeyword?? » Indicates a country, state or other region where the study is taking place location : CodeableConcept [0..*] « Countries and regions within which this artifact is targeted for use. null (Strength=Extensible) Jurisdiction ValueSet + » A full description brief summary of how the study is being conducted description descriptionSummary : markdown [0..1] Reference to a Group that defines the criteria for and quantity A full description of subjects participating in the study. E.g. " 200 female Europeans between how the ages study is being conducted. For a description of 20 and 45 with early onset diabetes" what the study objectives are see ResearchStudy.objective.description enrollment description : Reference [0..*] « Group markdown » [0..1] Identifies the start date and the expected (or actual, depending on status) end date for the study period : Period [0..1] Contact details to assist a user in learning more about or engaging with the study contact : ContactDetail [0..*] An organization that initiates the investigation and is legally responsible for the study sponsor : Reference [0..1] « Organization » 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 principalInvestigator : Reference [0..1] « Practitioner | PractitionerRole » A facility in which study activities are conducted site : Reference [0..*] « Location | ResearchStudy | Organization » Comments made about the study by the performer, subject or other participants note : Annotation [0..*] Current status of the study currentState : CodeableConcept [0..*] « null (Strength=Extensible) ResearchStudyStatus + » A description and/or code explaining the premature termination of the study reasonStopped whyStopped : CodeableConcept [0..1] « Codes for why the study ended prematurely. null (Strength=Example) ResearchStudyReasonStopped ?? » Comments made about the study Link to one or more sets of results generated by the performer, subject study. Could also link to a research registry holding the results such as ClinicalTrials.gov result : Reference [0..*] « EvidenceReport | Citation | DiagnosticReport » Label Kind of name type : CodeableConcept [0..1] « null (Strength=Extensible) ResearchStudyTitleType + » The name value : string [0..1] Focus Identification of product under study. This may be any combination of code and/or name productCode : CodeableConcept [0..1] « null (Strength=Example) ResearchStudyFocus?? » Indicates whether the focus is a medication, a device, a procedure, a specific factor or some other participants intervention or characteristic note focusType : Annotation CodeableConcept [0..*] « null (Strength=Extensible) ResearchStudyFocusType + » 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 : markdown [0..1] Arm Classification Type of classifier type : CodeableConcept [0..1] « null (Strength=Extensible) ResearchStudyCLassificationTy... + » Value of classifier classifier : CodeableConcept [0..*] « null (Strength=Extensible) ResearchStudyClassificationCl... + » AssociatedParty Name of associated party name : string [0..1] Type of association role : CodeableConcept [1..1] « null (Strength=Extensible) ResearchStudyPartyType + » Organisational type of association classifier : CodeableConcept [0..*] « null (Strength=Extensible) ResearchStudyPartyOrganizatio... + » Individual or organization associated with study (use practitionerRole to specify their organisation) party : Reference [0..1] « Practitioner | PractitionerRole | Organization » StatusDate Label for status or state activity : CodeableConcept [1..1] « null (Strength=Extensible) ResearchStudyStatusActivity + » Actual if true else anticipated actual : boolean [0..1] Date range period : Period [1..1] Recruitment Estimated total number of participants to be enrolled targetNumber : unsignedInt [0..1] Actual total number of participants enrolled in study actualNumber : unsignedInt [0..1] Inclusion and exclusion criteria eligibility : Reference [0..1] « Group » Group of participants who were enrolled in study actualGroup : Reference [0..1] « Group » ComparisonGroup Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily identifier[x] : DataType [0..1] « uri | Identifier » Unique, human-readable label for this arm comparisonGroup of the study name : string [1..1] Categorization of study arm, comparisonGroup, e.g. experimental, active comparator, placebo comparater type : CodeableConcept [0..1] « null (Strength=Extensible) ResearchStudyArmType + » A succinct description of the path through the study that would be followed by a subject adhering to this arm comparisonGroup description : string markdown [0..1] Interventions or exposures in this comparisonGroup or cohort intendedExposure : Reference [0..*] « EvidenceVariable » Group of participants who were enrolled in study comparisonGroup observedGroup : Reference [0..1] « Group » Objective Unique, human-readable label for this objective of the study name : string [0..1] The kind of study objective type : CodeableConcept [0..1] « Codes null (Strength=Preferred) ResearchStudyObjectiveType ? » 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) description : markdown [0..1] OutcomeMeasure Label for the kind outcome name : string [0..1] The parameter or characteristic being assessed as one of the values by which the study objective. is assessed type : CodeableConcept [0..*] « null (Strength=Preferred) ResearchStudyObjectiveType ? » Description of the outcome description : markdown [0..1] Structured outcome definition reference : Reference [0..1] « EvidenceVariable » WebLocation Describes the nature of the location being specified type : CodeableConcept [0..1] « null (Strength=Extensible) ResearchStudyUrlType + » The location address url : uri [1..1] Additional names for the study label [0..*] The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about focus [0..*] Classification for the study classification [0..*] Sponsors, collaborators, and other parties associatedParty [0..*] Status of study with time for that status statusDate [0..*] Target or actual group of participants enrolled in study recruitment [0..1] 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 arm comparisonGroup [0..*] 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 objective [0..*] An outcome or planned variable to measure during the study outcomeMeasure [0..*] A general storage or archive location for the study. This may contain an assortment of content which is not specified in advance webLocation [0..*]

XML Template 

<

<ResearchStudy xmlns="http://hl7.org/fhir"> doco

 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <url value="[uri]"/><!-- 0..1 Canonical identifier for this study resource -->

 <identifier><!-- 0..* Identifier Business Identifier for study --></identifier>
 <

 <version value="[string]"/><!-- 0..1 Business identifier for the study record -->
 <name value="[string]"/><!-- 0..1 Name for this study (computer friendly) -->
 <title value="[string]"/><!-- 0..1 Name for this study (for computers) -->
 <label>  <!-- 0..* Additional names for the study -->
  <type><!-- 0..1 CodeableConcept short | public | scientific  --></type>
  <value value="[string]"/><!-- 0..1 The name -->
 </label>

 <protocol><!-- 0..* Reference(PlanDefinition) Steps followed in executing study --></protocol>
 <partOf><!-- 0..* Reference(ResearchStudy) Part of larger study --></partOf>
 <
 <</primaryPurposeType>

 <relatedArtifact><!-- 0..* RelatedArtifact References and dependencies --></relatedArtifact>
 <date value="[dateTime]"/><!-- 0..1 Date the resource last changed -->
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <primaryPurposeType><!-- 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility --></primaryPurposeType>

 <phase><!-- 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 --></phase>
 <category><!-- 0..* CodeableConcept Classifications for the study --></category>
 <</focus>

 <focus>  <!-- 0..* Drugs, devices, etc. under study -->
  <productCode><!-- 0..1 CodeableConcept Identification of product under study --></productCode>
  <focusType><!-- 0..* CodeableConcept medication | device | intervention | factor  --></focusType>
  <factor value="[markdown]"/><!-- 0..1 An independent variable manipulated by the experimentalist -->
 </focus>

 <condition><!-- 0..* CodeableConcept Condition being studied --></condition>
 <</contact>
 <</relatedArtifact>

 <keyword><!-- 0..* CodeableConcept Used to search for the study --></keyword>
 <location><!-- 0..* CodeableConcept Geographic region(s) for study --></location>
 <
 <</enrollment>

 <descriptionSummary value="[markdown]"/><!-- 0..1 A brief summary of the study description -->
 <description value="[markdown]"/><!-- 0..1 What this is study doing -->

 <period><!-- 0..1 Period When the study began and ended --></period>
 <contact><!-- 0..* ContactDetail Contact details for the study --></contact>

 <sponsor><!-- 0..1 Reference(Organization) Organization that initiates and is legally responsible for the study --></sponsor>
 <principalInvestigator><!-- 0..1 Reference(Practitioner|PractitionerRole) Researcher who oversees multiple aspects of the study --></principalInvestigator>
 <</site>
 <</reasonStopped>

 <site><!-- 0..* Reference(Location|Organization|ResearchStudy) Facility where study activities are conducted --></site>

 <note><!-- 0..* Annotation Comments made about the study --></note>
 <
  <
  <</type>
  <
 </arm>

 <classification>  <!-- 0..* Classification for the study -->
  <type><!-- 0..1 CodeableConcept phase | category | keyword   --></type>
  <classifier><!-- 0..* CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4  --></classifier>
 </classification>
 <associatedParty>  <!-- 0..* Sponsors, collaborators, and other parties -->
  <name value="[string]"/><!-- 0..1 Name of associated party -->
  <role><!-- 1..1 CodeableConcept sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair  --></role>
  <classifier><!-- 0..* CodeableConcept nih | fda  --></classifier>
  <party><!-- 0..1 Reference(Organization|Practitioner|PractitionerRole) Individual or organization associated with study (use practitionerRole to specify their organisation) --></party>
 </associatedParty>
 <currentState><!-- 0..* CodeableConcept active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn --></currentState>
 <statusDate>  <!-- 0..* Status of study with time for that status -->
  <activity><!-- 1..1 CodeableConcept Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting  --></activity>
  <actual value="[boolean]"/><!-- 0..1 Actual if true else anticipated -->
  <period><!-- 1..1 Period Date range --></period>
 </statusDate>
 <whyStopped><!-- 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design --></whyStopped>
 <recruitment>  <!-- 0..1 Target or actual group of participants enrolled in study -->
  <targetNumber value="[unsignedInt]"/><!-- 0..1 Estimated total number of participants to be enrolled -->
  <actualNumber value="[unsignedInt]"/><!-- 0..1 Actual total number of participants enrolled in study -->
  <eligibility><!-- 0..1 Reference(Group) Inclusion and exclusion criteria --></eligibility>
  <actualGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study --></actualGroup>
 </recruitment>
 <comparisonGroup>  <!-- 0..* Defined path through the study for a subject -->
  <identifier[x]><!-- 0..1 uri|Identifier Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily --></identifier[x]>
  <name value="[string]"/><!-- 1..1 Label for study comparisonGroup -->
  <type><!-- 0..1 CodeableConcept Categorization of study comparisonGroup  --></type>
  <description value="[markdown]"/><!-- 0..1 Short explanation of study path -->
  <intendedExposure><!-- 0..* Reference(EvidenceVariable) Interventions or exposures in this comparisonGroup or cohort --></intendedExposure>
  <observedGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study comparisonGroup --></observedGroup>
 </comparisonGroup>

 <objective>  <!-- 0..* A goal for the study -->
  <name value="[string]"/><!-- 0..1 Label for the objective -->
  <type><!-- 0..1 CodeableConcept primary | secondary | exploratory --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the objective -->

 </objective>
 <outcomeMeasure>  <!-- 0..* An outcome or planned variable to measure during the study -->
  <name value="[string]"/><!-- 0..1 Label for the outcome -->
  <type><!-- 0..* CodeableConcept primary | secondary | exploratory --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the outcome -->
  <reference><!-- 0..1 Reference(EvidenceVariable) Structured outcome definition --></reference>
 </outcomeMeasure>
 <result><!-- 0..* Reference(Citation|DiagnosticReport|EvidenceReport) Link to results generated during the study --></result>
 <webLocation>  <!-- 0..* Archive location for the study -->
  <type><!-- 0..1 CodeableConcept registry-page|recruitment-page|contact-page  --></type>
  <url value="[uri]"/><!-- 1..1 The location address -->
 </webLocation>

</ResearchStudy>

JSON Template 

{doco
  "resourceType" : "",

  "resourceType" : "ResearchStudy",

  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "url" : "<uri>", // Canonical identifier for this study resource

  "identifier" : [{ Identifier }], // Business Identifier for study
  "

  "version" : "<string>", // Business identifier for the study record
  "name" : "<string>", // Name for this study (computer friendly)
  "title" : "<string>", // Name for this study (for computers)
  "label" : [{ // Additional names for the study
    "type" : { CodeableConcept }, // short | public | scientific 
    "value" : "<string>" // The name
  }],

  "protocol" : [{ Reference(PlanDefinition) }], // Steps followed in executing study
  "partOf" : [{ Reference(ResearchStudy) }], // Part of larger study
  "
  "

  "relatedArtifact" : [{ RelatedArtifact }], // References and dependencies
  "date" : "<dateTime>", // Date the resource last changed
  "status" : "<code>", // R!  draft | active | retired | unknown
  "primaryPurposeType" : { CodeableConcept }, // treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility

  "phase" : { CodeableConcept }, // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  "category" : [{ CodeableConcept }], // Classifications for the study
  "

  "focus" : [{ // Drugs, devices, etc. under study
    "productCode" : { CodeableConcept }, // Identification of product under study
    "focusType" : [{ CodeableConcept }], // medication | device | intervention | factor 
    "factor" : "<markdown>" // An independent variable manipulated by the experimentalist
  }],

  "condition" : [{ CodeableConcept }], // Condition being studied
  "
  "

  "keyword" : [{ CodeableConcept }], // Used to search for the study
  "location" : [{ CodeableConcept }], // Geographic region(s) for study
  "
  "

  "descriptionSummary" : "<markdown>", // A brief summary of the study description
  "description" : "<markdown>", // What this is study doing

  "period" : { Period }, // When the study began and ended
  "contact" : [{ ContactDetail }], // Contact details for the study

  "sponsor" : { Reference(Organization) }, // Organization that initiates and is legally responsible for the study
  "principalInvestigator" : { Reference(Practitioner|PractitionerRole) }, // Researcher who oversees multiple aspects of the study
  "
  "

  "site" : [{ Reference(Location|Organization|ResearchStudy) }], // Facility where study activities are conducted

  "note" : [{ Annotation }], // Comments made about the study
  "
    "
    "
    "

  "classification" : [{ // Classification for the study
    "type" : { CodeableConcept }, // phase | category | keyword  
    "classifier" : [{ CodeableConcept }] // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 
  }],
  "associatedParty" : [{ // Sponsors, collaborators, and other parties
    "name" : "<string>", // Name of associated party
    "role" : { CodeableConcept }, // R!  sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair 
    "classifier" : [{ CodeableConcept }], // nih | fda 
    "party" : { Reference(Organization|Practitioner|PractitionerRole) } // Individual or organization associated with study (use practitionerRole to specify their organisation)
  }],
  "currentState" : [{ CodeableConcept }], // active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  "statusDate" : [{ // Status of study with time for that status
    "activity" : { CodeableConcept }, // R!  Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting 
    "actual" : <boolean>, // Actual if true else anticipated
    "period" : { Period } // R!  Date range
  }],
  "whyStopped" : { CodeableConcept }, // accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  "recruitment" : { // Target or actual group of participants enrolled in study
    "targetNumber" : "<unsignedInt>", // Estimated total number of participants to be enrolled
    "actualNumber" : "<unsignedInt>", // Actual total number of participants enrolled in study
    "eligibility" : { Reference(Group) }, // Inclusion and exclusion criteria
    "actualGroup" : { Reference(Group) } // Group of participants who were enrolled in study
  },
  "comparisonGroup" : [{ // Defined path through the study for a subject
    // identifier[x]: 

      Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily. One of these 2:
    "identifierUri" : "<uri>",
    "identifierIdentifier" : { Identifier },
    "name" : "<string>", // R!  Label for study comparisonGroup
    "type" : { CodeableConcept }, // Categorization of study comparisonGroup 
    "description" : "<markdown>", // Short explanation of study path
    "intendedExposure" : [{ Reference(EvidenceVariable) }], // Interventions or exposures in this comparisonGroup or cohort
    "observedGroup" : { Reference(Group) } // Group of participants who were enrolled in study comparisonGroup

  }],
  "objective" : [{ // A goal for the study
    "name" : "<string>", // Label for the objective
    "

    "type" : { CodeableConcept }, // primary | secondary | exploratory
    "description" : "<markdown>" // Description of the objective
  }],
  "outcomeMeasure" : [{ // An outcome or planned variable to measure during the study
    "name" : "<string>", // Label for the outcome
    "type" : [{ CodeableConcept }], // primary | secondary | exploratory
    "description" : "<markdown>", // Description of the outcome
    "reference" : { Reference(EvidenceVariable) } // Structured outcome definition
  }],
  "result" : [{ Reference(Citation|DiagnosticReport|EvidenceReport) }], // Link to results generated during the study
  "webLocation" : [{ // Archive location for the study
    "type" : { CodeableConcept }, // registry-page|recruitment-page|contact-page 
    "url" : "<uri>" // R!  The location address

  }]
}

Turtle Template 

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:;

[ a fhir:ResearchStudy;

  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:ResearchStudy.url [ uri ]; # 0..1 Canonical identifier for this study resource

  fhir:ResearchStudy.identifier [ Identifier ], ... ; # 0..* Business Identifier for study
  fhir:

  fhir:ResearchStudy.version [ string ]; # 0..1 Business identifier for the study record
  fhir:ResearchStudy.name [ string ]; # 0..1 Name for this study (computer friendly)
  fhir:ResearchStudy.title [ string ]; # 0..1 Name for this study (for computers)
  fhir:ResearchStudy.label [ # 0..* Additional names for the study
    fhir:ResearchStudy.label.type [ CodeableConcept ]; # 0..1 short | public | scientific
    fhir:ResearchStudy.label.value [ string ]; # 0..1 The name
  ], ...;

  fhir:ResearchStudy.protocol [ Reference(PlanDefinition) ], ... ; # 0..* Steps followed in executing study
  fhir:ResearchStudy.partOf [ Reference(ResearchStudy) ], ... ; # 0..* Part of larger study
  fhir:
  fhir:

  fhir:ResearchStudy.relatedArtifact [ RelatedArtifact ], ... ; # 0..* References and dependencies
  fhir:ResearchStudy.date [ dateTime ]; # 0..1 Date the resource last changed
  fhir:ResearchStudy.status [ code ]; # 1..1 draft | active | retired | unknown
  fhir:ResearchStudy.primaryPurposeType [ CodeableConcept ]; # 0..1 treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility

  fhir:ResearchStudy.phase [ CodeableConcept ]; # 0..1 n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  fhir:ResearchStudy.category [ CodeableConcept ], ... ; # 0..* Classifications for the study
  fhir:

  fhir:ResearchStudy.focus [ # 0..* Drugs, devices, etc. under study
    fhir:ResearchStudy.focus.productCode [ CodeableConcept ]; # 0..1 Identification of product under study
    fhir:ResearchStudy.focus.focusType [ CodeableConcept ], ... ; # 0..* medication | device | intervention | factor
    fhir:ResearchStudy.focus.factor [ markdown ]; # 0..1 An independent variable manipulated by the experimentalist
  ], ...;

  fhir:ResearchStudy.condition [ CodeableConcept ], ... ; # 0..* Condition being studied
  fhir:
  fhir:

  fhir:ResearchStudy.keyword [ CodeableConcept ], ... ; # 0..* Used to search for the study
  fhir:ResearchStudy.location [ CodeableConcept ], ... ; # 0..* Geographic region(s) for study
  fhir:
  fhir:

  fhir:ResearchStudy.descriptionSummary [ markdown ]; # 0..1 A brief summary of the study description
  fhir:ResearchStudy.description [ markdown ]; # 0..1 What this is study doing

  fhir:ResearchStudy.period [ Period ]; # 0..1 When the study began and ended
  fhir:ResearchStudy.contact [ ContactDetail ], ... ; # 0..* Contact details for the study

  fhir:ResearchStudy.sponsor [ Reference(Organization) ]; # 0..1 Organization that initiates and is legally responsible for the study
  fhir:ResearchStudy.principalInvestigator [ Reference(Practitioner|PractitionerRole) ]; # 0..1 Researcher who oversees multiple aspects of the study
  fhir:
  fhir:

  fhir:ResearchStudy.site [ Reference(Location|Organization|ResearchStudy) ], ... ; # 0..* Facility where study activities are conducted

  fhir:ResearchStudy.note [ Annotation ], ... ; # 0..* Comments made about the study
  fhir:
    fhir:
    fhir:
    fhir:

  fhir:ResearchStudy.classification [ # 0..* Classification for the study
    fhir:ResearchStudy.classification.type [ CodeableConcept ]; # 0..1 phase | category | keyword 
    fhir:ResearchStudy.classification.classifier [ CodeableConcept ], ... ; # 0..* n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  ], ...;
  fhir:ResearchStudy.associatedParty [ # 0..* Sponsors, collaborators, and other parties
    fhir:ResearchStudy.associatedParty.name [ string ]; # 0..1 Name of associated party
    fhir:ResearchStudy.associatedParty.role [ CodeableConcept ]; # 1..1 sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair
    fhir:ResearchStudy.associatedParty.classifier [ CodeableConcept ], ... ; # 0..* nih | fda
    fhir:ResearchStudy.associatedParty.party [ Reference(Organization|Practitioner|PractitionerRole) ]; # 0..1 Individual or organization associated with study (use practitionerRole to specify their organisation)
  ], ...;
  fhir:ResearchStudy.currentState [ CodeableConcept ], ... ; # 0..* active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  fhir:ResearchStudy.statusDate [ # 0..* Status of study with time for that status
    fhir:ResearchStudy.statusDate.activity [ CodeableConcept ]; # 1..1 Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting
    fhir:ResearchStudy.statusDate.actual [ boolean ]; # 0..1 Actual if true else anticipated
    fhir:ResearchStudy.statusDate.period [ Period ]; # 1..1 Date range
  ], ...;
  fhir:ResearchStudy.whyStopped [ CodeableConcept ]; # 0..1 accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  fhir:ResearchStudy.recruitment [ # 0..1 Target or actual group of participants enrolled in study
    fhir:ResearchStudy.recruitment.targetNumber [ unsignedInt ]; # 0..1 Estimated total number of participants to be enrolled
    fhir:ResearchStudy.recruitment.actualNumber [ unsignedInt ]; # 0..1 Actual total number of participants enrolled in study
    fhir:ResearchStudy.recruitment.eligibility [ Reference(Group) ]; # 0..1 Inclusion and exclusion criteria
    fhir:ResearchStudy.recruitment.actualGroup [ Reference(Group) ]; # 0..1 Group of participants who were enrolled in study
  ];
  fhir:ResearchStudy.comparisonGroup [ # 0..* Defined path through the study for a subject
    # ResearchStudy.comparisonGroup.identifier[x] : 0..1 Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily. One of these 2
      fhir:ResearchStudy.comparisonGroup.identifierUri [ uri ]
      fhir:ResearchStudy.comparisonGroup.identifierIdentifier [ Identifier ]
    fhir:ResearchStudy.comparisonGroup.name [ string ]; # 1..1 Label for study comparisonGroup
    fhir:ResearchStudy.comparisonGroup.type [ CodeableConcept ]; # 0..1 Categorization of study comparisonGroup
    fhir:ResearchStudy.comparisonGroup.description [ markdown ]; # 0..1 Short explanation of study path
    fhir:ResearchStudy.comparisonGroup.intendedExposure [ Reference(EvidenceVariable) ], ... ; # 0..* Interventions or exposures in this comparisonGroup or cohort
    fhir:ResearchStudy.comparisonGroup.observedGroup [ Reference(Group) ]; # 0..1 Group of participants who were enrolled in study comparisonGroup

  ], ...;
  fhir:ResearchStudy.objective [ # 0..* A goal for the study
    fhir:ResearchStudy.objective.name [ string ]; # 0..1 Label for the objective
    fhir:ResearchStudy.objective.type [ CodeableConcept ]; # 0..1 primary | secondary | exploratory
    fhir:ResearchStudy.objective.description [ markdown ]; # 0..1 Description of the objective
  ], ...;
  fhir:ResearchStudy.outcomeMeasure [ # 0..* An outcome or planned variable to measure during the study
    fhir:ResearchStudy.outcomeMeasure.name [ string ]; # 0..1 Label for the outcome
    fhir:ResearchStudy.outcomeMeasure.type [ CodeableConcept ], ... ; # 0..* primary | secondary | exploratory
    fhir:ResearchStudy.outcomeMeasure.description [ markdown ]; # 0..1 Description of the outcome
    fhir:ResearchStudy.outcomeMeasure.reference [ Reference(EvidenceVariable) ]; # 0..1 Structured outcome definition
  ], ...;
  fhir:ResearchStudy.result [ Reference(Citation|DiagnosticReport|EvidenceReport) ], ... ; # 0..* Link to results generated during the study
  fhir:ResearchStudy.webLocation [ # 0..* Archive location for the study
    fhir:ResearchStudy.webLocation.type [ CodeableConcept ]; # 0..1 registry-page|recruitment-page|contact-page
    fhir:ResearchStudy.webLocation.url [ uri ]; # 1..1 The location address

  ], ...;
]

Changes since R3

ResearchStudy
ResearchStudy.url
  • Added Element
ResearchStudy.version
  • Added Element
ResearchStudy.name
  • Added Element
ResearchStudy.label
  • Added Element
ResearchStudy.label.type
  • Added Element
ResearchStudy.label.value
  • Added Element
ResearchStudy.date
  • Added Element
ResearchStudy.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-study-status http://hl7.org/fhir/ValueSet/research-study-status|4.0.0 to http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 http://hl7.org/fhir/ValueSet/publication-status|5.0.0-snapshot1
ResearchStudy.focus
  • Type changed from CodeableConcept to BackboneElement
ResearchStudy.primaryPurposeType ResearchStudy.focus.productCode
  • Added Element
ResearchStudy.phase ResearchStudy.focus.focusType
  • Added Element
ResearchStudy.condition ResearchStudy.focus.factor
  • Added Element
ResearchStudy.location ResearchStudy.descriptionSummary
  • Added Element
ResearchStudy.principalInvestigator ResearchStudy.site
  • Type Reference: Added Target Type PractitionerRole Types ResearchStudy, Organization
ResearchStudy.arm.type ResearchStudy.classification
  • Added Element
ResearchStudy.objective ResearchStudy.classification.type
  • Added Element
ResearchStudy.objective.name ResearchStudy.classification.classifier
  • Added Element
ResearchStudy.objective.type ResearchStudy.associatedParty
  • Added Element
ResearchStudy.associatedParty.name
  • Added Element
ResearchStudy.associatedParty.role
  • Added Mandatory Element
ResearchStudy.associatedParty.classifier
  • Added Element
ResearchStudy.associatedParty.party
  • Added Element
ResearchStudy.currentState
  • Added Element
ResearchStudy.statusDate
  • Added Element
ResearchStudy.statusDate.activity
  • Added Mandatory Element
ResearchStudy.statusDate.actual
  • Added Element
ResearchStudy.statusDate.period
  • Added Mandatory Element
ResearchStudy.whyStopped
  • Added Element
ResearchStudy.recruitment
  • Added Element
ResearchStudy.recruitment.targetNumber
  • Added Element
ResearchStudy.recruitment.actualNumber
  • Added Element
ResearchStudy.recruitment.eligibility
  • Added Element
ResearchStudy.recruitment.actualGroup
  • Added Element
ResearchStudy.comparisonGroup
  • Added Element
ResearchStudy.comparisonGroup.identifier[x]
  • Added Element
ResearchStudy.comparisonGroup.name
  • Added Mandatory Element
ResearchStudy.comparisonGroup.type
  • Added Element
ResearchStudy.comparisonGroup.description
  • Added Element
ResearchStudy.comparisonGroup.intendedExposure
  • Added Element
ResearchStudy.comparisonGroup.observedGroup
  • Added Element
ResearchStudy.objective.description
  • Added Element
ResearchStudy.outcomeMeasure
  • Added Element
ResearchStudy.outcomeMeasure.name
  • Added Element
ResearchStudy.outcomeMeasure.type
  • Added Element
ResearchStudy.outcomeMeasure.description
  • Added Element
ResearchStudy.outcomeMeasure.reference
  • Added Element
ResearchStudy.result
  • Added Element
ResearchStudy.webLocation
  • Added Element
ResearchStudy.webLocation.type
  • Added Element
ResearchStudy.webLocation.url
  • Added Mandatory Element
ResearchStudy.jurisdiction ResearchStudy.enrollment
  • deleted
ResearchStudy.arm.code ResearchStudy.reasonStopped
  • deleted
ResearchStudy.arm
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON .

See R3 <--> R4 Conversion Maps (status = 1 test that all execute ok. All tests pass round-trip testing and all r3 resources are valid.)

Structure

Name Flags Card. Type Description & Constraints doco
. . ResearchStudy TU DomainResource Investigation to increase healthcare-related patient-independent knowledge
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . url 0..1 uri Canonical identifier for this study resource
... identifier Σ 0..* Identifier Business Identifier for study
. . . version 0..1 string Business identifier for the study record
. . . name 0..1 string Name for this study (computer friendly)
... title Σ 0..1 string Name for this study (for computers)
. . . label 0..* BackboneElement Additional names for the study
.... type 0..1 CodeableConcept short | public | scientific
ResearchStudyTitleType ( Extensible )
.... value 0..1 string The name
. . . protocol Σ 0..* Reference ( PlanDefinition ) Steps followed in executing study
. . . partOf Σ 0..* Reference ( ResearchStudy ) Part of larger study
. . . relatedArtifact 0..* RelatedArtifact References and dependencies
... date 0..1 dateTime Date the resource last changed
. . . status ?! Σ 1..1 code active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review draft | temporarily-closed-to-accrual active | temporarily-closed-to-accrual-and-intervention retired | withdrawn unknown
ResearchStudyStatus PublicationStatus ( Required )
. . . primaryPurposeType Σ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
ResearchStudyPrimaryPurposeType ( Extensible )
. . . phase Σ 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
ResearchStudyPhase ( Example )
. . . category Σ 0..* CodeableConcept Classifications for the study
ResearchStudyCategory ( Example )
. . . focus Σ 0..* CodeableConcept BackboneElement Drugs, devices, etc. under study
. . . . condition productCode Σ 0..* 0..1 CodeableConcept Condition being studied Identification of product under study
Condition/Problem/Diagnosis Codes ResearchStudyFocus ( Example )
. . . . contact focusType Σ 0..* ContactDetail CodeableConcept Contact details for the study medication | device | intervention | factor
ResearchStudyFocusType ( Extensible )
. . relatedArtifact . . factor 0..* 0..1 RelatedArtifact markdown References and dependencies An independent variable manipulated by the experimentalist
. . . keyword condition Σ 0..* CodeableConcept Condition being studied
Condition/Problem/Diagnosis Codes ( Example )
... keyword Σ 0..* CodeableConcept Used to search for the study
ResearchStudyKeyword ( Example )
. . . location Σ 0..* CodeableConcept Geographic region(s) for study
Jurisdiction ( Extensible )
. . . descriptionSummary 0..1 markdown A brief summary of the study description
. . . description 0..1 markdown What this is study doing
. . enrollment . period Σ 0..* 0..1 Reference ( Group Period ) Inclusion & exclusion criteria When the study began and ended
. . . period contact Σ 0..1 0..* Period ContactDetail When Contact details for the study began and ended
. . . sponsor Σ 0..1 Reference ( Organization ) Organization that initiates and is legally responsible for the study
. . . principalInvestigator Σ 0..1 Reference ( Practitioner | PractitionerRole ) Researcher who oversees multiple aspects of the study
. . . site Σ 0..* Reference ( Location | ResearchStudy | Organization ) Facility where study activities are conducted
. . . reasonStopped note 0..* Annotation Comments made about the study
... classification 0..* BackboneElement Classification for the study
.... type 0..1 CodeableConcept phase | category | keyword
ResearchStudyCLassificationType ( Extensible )
.... classifier 0..* CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
ResearchStudyClassificationClassifier ( Extensible )
... associatedParty 0..* BackboneElement Sponsors, collaborators, and other parties
.... name 0..1 string Name of associated party
.... role 1..1 CodeableConcept sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair
ResearchStudyPartyType ( Extensible )
.... classifier 0..* CodeableConcept nih | fda
ResearchStudyPartyOrganizationType ( Extensible )
.... party 0..1 Reference ( Practitioner | PractitionerRole | Organization ) Individual or organization associated with study (use practitionerRole to specify their organisation)
... currentState 0..* CodeableConcept active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
ResearchStudyStatus ( Extensible )
... statusDate 0..* BackboneElement Status of study with time for that status
.... activity 1..1 CodeableConcept Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting
ResearchStudyStatusActivity ( Extensible )
.... actual 0..1 boolean Actual if true else anticipated
.... period 1..1 Period Date range
... whyStopped Σ 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
ResearchStudyReasonStopped ( Example )
. . . recruitment Σ 0..1 BackboneElement Target or actual group of participants enrolled in study
.. . note . targetNumber 0..1 unsignedInt Estimated total number of participants to be enrolled
.... actualNumber 0..* 0..1 Annotation unsignedInt Comments made about the Actual total number of participants enrolled in study
. . . . eligibility 0..1 Reference ( Group ) Inclusion and exclusion criteria
.... actualGroup Σ 0..1 Reference ( Group ) Group of participants who were enrolled in study
. . . arm comparisonGroup 0..* BackboneElement Defined path through the study for a subject
. . . name . identifier[x] 1..1 0..1 Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
..... identifierUri uri
..... identifierIdentifier Identifier
.... name 1..1 string Label for study arm comparisonGroup
. . . . type 0..1 CodeableConcept Categorization of study arm comparisonGroup
ResearchStudyArmType ( Extensible )
. . . . description 0..1 string markdown Short explanation of study path
. . . . intendedExposure 0..* Reference ( EvidenceVariable ) Interventions or exposures in this comparisonGroup or cohort
. . . . observedGroup 0..1 Reference ( Group ) Group of participants who were enrolled in study comparisonGroup
... objective 0..* BackboneElement A goal for the study
. . . . name 0..1 string Label for the objective
. . . . type 0..1 CodeableConcept primary | secondary | exploratory
ResearchStudyObjectiveType ( Preferred )
.... description 0..1 markdown Description of the objective
... outcomeMeasure 0..* BackboneElement An outcome or planned variable to measure during the study
.... name 0..1 string Label for the outcome
.... type 0..* CodeableConcept primary | secondary | exploratory
ResearchStudyObjectiveType ( Preferred )
. . . . description 0..1 markdown Description of the outcome
.... reference 0..1 Reference ( EvidenceVariable ) Structured outcome definition
... result Σ 0..* Reference ( EvidenceReport | Citation | DiagnosticReport ) Link to results generated during the study
... webLocation 0..* BackboneElement Archive location for the study
.... type 0..1 CodeableConcept registry-page|recruitment-page|contact-page
ResearchStudyUrlType ( Extensible )
.... url 1..1 uri The location address

doco Documentation for this format

UML Diagram ( Legend )

ResearchStudy ( DomainResource ) Canonical identifier for this study resource, represented as a globally unique URI url : uri [0..1] Identifiers assigned to this research study by the sponsor or other systems identifier : Identifier [0..*] Business identifier for the study record version : string [0..1] Name for this study (computer friendly) name : string [0..1] A short, descriptive user-friendly label for the study particularly for compouter use title : string [0..1] The set of steps expected to be performed as part of the execution of the study protocol : Reference [0..*] « PlanDefinition » A larger research study of which this particular study is a component or step partOf : Reference [0..*] « ResearchStudy » Citations, references and other related documents relatedArtifact : RelatedArtifact [0..*] Date the resource last changed date : dateTime [0..1] The current publication state of the study resource (not of the study) (this element modifies the meaning of other elements) status : code [1..1] « Codes that convey the current status of the research study. null (Strength=Required) ResearchStudyStatus PublicationStatus ! » The type of study based upon the intent of the study's study activities. A classification of the intent of the study primaryPurposeType : CodeableConcept [0..1] « Codes for the main intent of the study. null (Strength=Extensible) ResearchStudyPrimaryPurposeTy... + » The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation phase : CodeableConcept [0..1] « Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. null (Strength=Example) ResearchStudyPhase ?? » Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc category : CodeableConcept [0..*] « The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about null (Strength=Example) focus : CodeableConcept [0..*] ResearchStudyCategory?? » 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 "healthy volunteer", but the target condition code would be a Lupus SNOMED code condition : CodeableConcept [0..*] « Identification of the condition or diagnosis. null (Strength=Example) Condition/Problem/DiagnosisCo... ?? » Contact details to assist a user in learning more about or engaging with the study contact : ContactDetail [0..*] Citations, references and other related documents relatedArtifact : RelatedArtifact [0..*] Key terms to aid in searching for or filtering the study keyword : CodeableConcept [0..*] « null (Strength=Example) ResearchStudyKeyword?? » Indicates a country, state or other region where the study is taking place location : CodeableConcept [0..*] « Countries and regions within which this artifact is targeted for use. null (Strength=Extensible) Jurisdiction ValueSet + » A full description brief summary of how the study is being conducted description descriptionSummary : markdown [0..1] Reference to a Group that defines the criteria for and quantity A full description of subjects participating in the study. E.g. " 200 female Europeans between how the ages study is being conducted. For a description of 20 and 45 with early onset diabetes" what the study objectives are see ResearchStudy.objective.description enrollment description : Reference [0..*] « Group markdown » [0..1] Identifies the start date and the expected (or actual, depending on status) end date for the study period : Period [0..1] Contact details to assist a user in learning more about or engaging with the study contact : ContactDetail [0..*] An organization that initiates the investigation and is legally responsible for the study sponsor : Reference [0..1] « Organization » 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 principalInvestigator : Reference [0..1] « Practitioner | PractitionerRole » A facility in which study activities are conducted site : Reference [0..*] « Location | ResearchStudy | Organization » Comments made about the study by the performer, subject or other participants note : Annotation [0..*] Current status of the study currentState : CodeableConcept [0..*] « null (Strength=Extensible) ResearchStudyStatus + » A description and/or code explaining the premature termination of the study reasonStopped whyStopped : CodeableConcept [0..1] « Codes for why the study ended prematurely. null (Strength=Example) ResearchStudyReasonStopped ?? » Comments made about the study Link to one or more sets of results generated by the performer, subject study. Could also link to a research registry holding the results such as ClinicalTrials.gov result : Reference [0..*] « EvidenceReport | Citation | DiagnosticReport » Label Kind of name type : CodeableConcept [0..1] « null (Strength=Extensible) ResearchStudyTitleType + » The name value : string [0..1] Focus Identification of product under study. This may be any combination of code and/or name productCode : CodeableConcept [0..1] « null (Strength=Example) ResearchStudyFocus?? » Indicates whether the focus is a medication, a device, a procedure, a specific factor or some other participants intervention or characteristic note focusType : Annotation CodeableConcept [0..*] « null (Strength=Extensible) ResearchStudyFocusType + » 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 : markdown [0..1] Classification Type of classifier type : CodeableConcept [0..1] « null (Strength=Extensible) ResearchStudyCLassificationTy... + » Value of classifier classifier : CodeableConcept [0..*] « null (Strength=Extensible) ResearchStudyClassificationCl... + » Arm AssociatedParty Name of associated party name : string [0..1] Type of association role : CodeableConcept [1..1] « null (Strength=Extensible) ResearchStudyPartyType + » Organisational type of association classifier : CodeableConcept [0..*] « null (Strength=Extensible) ResearchStudyPartyOrganizatio... + » Individual or organization associated with study (use practitionerRole to specify their organisation) party : Reference [0..1] « Practitioner | PractitionerRole | Organization » StatusDate Label for status or state activity : CodeableConcept [1..1] « null (Strength=Extensible) ResearchStudyStatusActivity + » Actual if true else anticipated actual : boolean [0..1] Date range period : Period [1..1] Recruitment Estimated total number of participants to be enrolled targetNumber : unsignedInt [0..1] Actual total number of participants enrolled in study actualNumber : unsignedInt [0..1] Inclusion and exclusion criteria eligibility : Reference [0..1] « Group » Group of participants who were enrolled in study actualGroup : Reference [0..1] « Group » ComparisonGroup Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily identifier[x] : DataType [0..1] « uri | Identifier » Unique, human-readable label for this arm comparisonGroup of the study name : string [1..1] Categorization of study arm, comparisonGroup, e.g. experimental, active comparator, placebo comparater type : CodeableConcept [0..1] « null (Strength=Extensible) ResearchStudyArmType + » A succinct description of the path through the study that would be followed by a subject adhering to this arm comparisonGroup description : string markdown [0..1] Interventions or exposures in this comparisonGroup or cohort intendedExposure : Reference [0..*] « EvidenceVariable » Group of participants who were enrolled in study comparisonGroup observedGroup : Reference [0..1] « Group » Objective Unique, human-readable label for this objective of the study name : string [0..1] The kind of study objective type : CodeableConcept [0..1] « Codes null (Strength=Preferred) ResearchStudyObjectiveType ? » 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) description : markdown [0..1] OutcomeMeasure Label for the kind outcome name : string [0..1] The parameter or characteristic being assessed as one of the values by which the study objective. is assessed type : CodeableConcept [0..*] « null (Strength=Preferred) ResearchStudyObjectiveType ? » Description of the outcome description : markdown [0..1] Structured outcome definition reference : Reference [0..1] « EvidenceVariable » WebLocation Describes the nature of the location being specified type : CodeableConcept [0..1] « null (Strength=Extensible) ResearchStudyUrlType + » The location address url : uri [1..1] Additional names for the study label [0..*] The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about focus [0..*] Classification for the study classification [0..*] Sponsors, collaborators, and other parties associatedParty [0..*] Status of study with time for that status statusDate [0..*] Target or actual group of participants enrolled in study recruitment [0..1] 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 arm comparisonGroup [0..*] 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 objective [0..*] An outcome or planned variable to measure during the study outcomeMeasure [0..*] A general storage or archive location for the study. This may contain an assortment of content which is not specified in advance webLocation [0..*]

XML Template 

<

<ResearchStudy xmlns="http://hl7.org/fhir"> doco

 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <url value="[uri]"/><!-- 0..1 Canonical identifier for this study resource -->

 <identifier><!-- 0..* Identifier Business Identifier for study --></identifier>
 <

 <version value="[string]"/><!-- 0..1 Business identifier for the study record -->
 <name value="[string]"/><!-- 0..1 Name for this study (computer friendly) -->
 <title value="[string]"/><!-- 0..1 Name for this study (for computers) -->
 <label>  <!-- 0..* Additional names for the study -->
  <type><!-- 0..1 CodeableConcept short | public | scientific  --></type>
  <value value="[string]"/><!-- 0..1 The name -->
 </label>

 <protocol><!-- 0..* Reference(PlanDefinition) Steps followed in executing study --></protocol>
 <partOf><!-- 0..* Reference(ResearchStudy) Part of larger study --></partOf>
 <
 <</primaryPurposeType>

 <relatedArtifact><!-- 0..* RelatedArtifact References and dependencies --></relatedArtifact>
 <date value="[dateTime]"/><!-- 0..1 Date the resource last changed -->
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <primaryPurposeType><!-- 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility --></primaryPurposeType>

 <phase><!-- 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 --></phase>
 <category><!-- 0..* CodeableConcept Classifications for the study --></category>
 <</focus>

 <focus>  <!-- 0..* Drugs, devices, etc. under study -->
  <productCode><!-- 0..1 CodeableConcept Identification of product under study --></productCode>
  <focusType><!-- 0..* CodeableConcept medication | device | intervention | factor  --></focusType>
  <factor value="[markdown]"/><!-- 0..1 An independent variable manipulated by the experimentalist -->
 </focus>

 <condition><!-- 0..* CodeableConcept Condition being studied --></condition>
 <</contact>
 <</relatedArtifact>

 <keyword><!-- 0..* CodeableConcept Used to search for the study --></keyword>
 <location><!-- 0..* CodeableConcept Geographic region(s) for study --></location>
 <
 <</enrollment>

 <descriptionSummary value="[markdown]"/><!-- 0..1 A brief summary of the study description -->
 <description value="[markdown]"/><!-- 0..1 What this is study doing -->

 <period><!-- 0..1 Period When the study began and ended --></period>
 <contact><!-- 0..* ContactDetail Contact details for the study --></contact>

 <sponsor><!-- 0..1 Reference(Organization) Organization that initiates and is legally responsible for the study --></sponsor>
 <principalInvestigator><!-- 0..1 Reference(Practitioner|PractitionerRole) Researcher who oversees multiple aspects of the study --></principalInvestigator>
 <</site>
 <</reasonStopped>

 <site><!-- 0..* Reference(Location|Organization|ResearchStudy) Facility where study activities are conducted --></site>

 <note><!-- 0..* Annotation Comments made about the study --></note>
 <
  <
  <</type>
  <
 </arm>

 <classification>  <!-- 0..* Classification for the study -->
  <type><!-- 0..1 CodeableConcept phase | category | keyword   --></type>
  <classifier><!-- 0..* CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4  --></classifier>
 </classification>
 <associatedParty>  <!-- 0..* Sponsors, collaborators, and other parties -->
  <name value="[string]"/><!-- 0..1 Name of associated party -->
  <role><!-- 1..1 CodeableConcept sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair  --></role>
  <classifier><!-- 0..* CodeableConcept nih | fda  --></classifier>
  <party><!-- 0..1 Reference(Organization|Practitioner|PractitionerRole) Individual or organization associated with study (use practitionerRole to specify their organisation) --></party>
 </associatedParty>
 <currentState><!-- 0..* CodeableConcept active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn --></currentState>
 <statusDate>  <!-- 0..* Status of study with time for that status -->
  <activity><!-- 1..1 CodeableConcept Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting  --></activity>
  <actual value="[boolean]"/><!-- 0..1 Actual if true else anticipated -->
  <period><!-- 1..1 Period Date range --></period>
 </statusDate>
 <whyStopped><!-- 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design --></whyStopped>
 <recruitment>  <!-- 0..1 Target or actual group of participants enrolled in study -->
  <targetNumber value="[unsignedInt]"/><!-- 0..1 Estimated total number of participants to be enrolled -->
  <actualNumber value="[unsignedInt]"/><!-- 0..1 Actual total number of participants enrolled in study -->
  <eligibility><!-- 0..1 Reference(Group) Inclusion and exclusion criteria --></eligibility>
  <actualGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study --></actualGroup>
 </recruitment>
 <comparisonGroup>  <!-- 0..* Defined path through the study for a subject -->
  <identifier[x]><!-- 0..1 uri|Identifier Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily --></identifier[x]>
  <name value="[string]"/><!-- 1..1 Label for study comparisonGroup -->
  <type><!-- 0..1 CodeableConcept Categorization of study comparisonGroup  --></type>
  <description value="[markdown]"/><!-- 0..1 Short explanation of study path -->
  <intendedExposure><!-- 0..* Reference(EvidenceVariable) Interventions or exposures in this comparisonGroup or cohort --></intendedExposure>
  <observedGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study comparisonGroup --></observedGroup>
 </comparisonGroup>

 <objective>  <!-- 0..* A goal for the study -->
  <name value="[string]"/><!-- 0..1 Label for the objective -->
  <type><!-- 0..1 CodeableConcept primary | secondary | exploratory --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the objective -->

 </objective>
 <outcomeMeasure>  <!-- 0..* An outcome or planned variable to measure during the study -->
  <name value="[string]"/><!-- 0..1 Label for the outcome -->
  <type><!-- 0..* CodeableConcept primary | secondary | exploratory --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the outcome -->
  <reference><!-- 0..1 Reference(EvidenceVariable) Structured outcome definition --></reference>
 </outcomeMeasure>
 <result><!-- 0..* Reference(Citation|DiagnosticReport|EvidenceReport) Link to results generated during the study --></result>
 <webLocation>  <!-- 0..* Archive location for the study -->
  <type><!-- 0..1 CodeableConcept registry-page|recruitment-page|contact-page  --></type>
  <url value="[uri]"/><!-- 1..1 The location address -->
 </webLocation>

</ResearchStudy>

JSON Template 

{doco
  "resourceType" : "",

  "resourceType" : "ResearchStudy",

  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "url" : "<uri>", // Canonical identifier for this study resource

  "identifier" : [{ Identifier }], // Business Identifier for study
  "

  "version" : "<string>", // Business identifier for the study record
  "name" : "<string>", // Name for this study (computer friendly)
  "title" : "<string>", // Name for this study (for computers)
  "label" : [{ // Additional names for the study
    "type" : { CodeableConcept }, // short | public | scientific 
    "value" : "<string>" // The name
  }],

  "protocol" : [{ Reference(PlanDefinition) }], // Steps followed in executing study
  "partOf" : [{ Reference(ResearchStudy) }], // Part of larger study
  "
  "

  "relatedArtifact" : [{ RelatedArtifact }], // References and dependencies
  "date" : "<dateTime>", // Date the resource last changed
  "status" : "<code>", // R!  draft | active | retired | unknown
  "primaryPurposeType" : { CodeableConcept }, // treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility

  "phase" : { CodeableConcept }, // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  "category" : [{ CodeableConcept }], // Classifications for the study
  "

  "focus" : [{ // Drugs, devices, etc. under study
    "productCode" : { CodeableConcept }, // Identification of product under study
    "focusType" : [{ CodeableConcept }], // medication | device | intervention | factor 
    "factor" : "<markdown>" // An independent variable manipulated by the experimentalist
  }],

  "condition" : [{ CodeableConcept }], // Condition being studied
  "
  "

  "keyword" : [{ CodeableConcept }], // Used to search for the study
  "location" : [{ CodeableConcept }], // Geographic region(s) for study
  "
  "

  "descriptionSummary" : "<markdown>", // A brief summary of the study description
  "description" : "<markdown>", // What this is study doing

  "period" : { Period }, // When the study began and ended
  "contact" : [{ ContactDetail }], // Contact details for the study

  "sponsor" : { Reference(Organization) }, // Organization that initiates and is legally responsible for the study
  "principalInvestigator" : { Reference(Practitioner|PractitionerRole) }, // Researcher who oversees multiple aspects of the study
  "
  "

  "site" : [{ Reference(Location|Organization|ResearchStudy) }], // Facility where study activities are conducted

  "note" : [{ Annotation }], // Comments made about the study
  "
    "
    "
    "

  "classification" : [{ // Classification for the study
    "type" : { CodeableConcept }, // phase | category | keyword  
    "classifier" : [{ CodeableConcept }] // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 
  }],
  "associatedParty" : [{ // Sponsors, collaborators, and other parties
    "name" : "<string>", // Name of associated party
    "role" : { CodeableConcept }, // R!  sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair 
    "classifier" : [{ CodeableConcept }], // nih | fda 
    "party" : { Reference(Organization|Practitioner|PractitionerRole) } // Individual or organization associated with study (use practitionerRole to specify their organisation)
  }],
  "currentState" : [{ CodeableConcept }], // active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  "statusDate" : [{ // Status of study with time for that status
    "activity" : { CodeableConcept }, // R!  Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting 
    "actual" : <boolean>, // Actual if true else anticipated
    "period" : { Period } // R!  Date range
  }],
  "whyStopped" : { CodeableConcept }, // accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  "recruitment" : { // Target or actual group of participants enrolled in study
    "targetNumber" : "<unsignedInt>", // Estimated total number of participants to be enrolled
    "actualNumber" : "<unsignedInt>", // Actual total number of participants enrolled in study
    "eligibility" : { Reference(Group) }, // Inclusion and exclusion criteria
    "actualGroup" : { Reference(Group) } // Group of participants who were enrolled in study
  },
  "comparisonGroup" : [{ // Defined path through the study for a subject
    // identifier[x]: 

      Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily. One of these 2:
    "identifierUri" : "<uri>",
    "identifierIdentifier" : { Identifier },
    "name" : "<string>", // R!  Label for study comparisonGroup
    "type" : { CodeableConcept }, // Categorization of study comparisonGroup 
    "description" : "<markdown>", // Short explanation of study path
    "intendedExposure" : [{ Reference(EvidenceVariable) }], // Interventions or exposures in this comparisonGroup or cohort
    "observedGroup" : { Reference(Group) } // Group of participants who were enrolled in study comparisonGroup

  }],
  "objective" : [{ // A goal for the study
    "name" : "<string>", // Label for the objective
    "

    "type" : { CodeableConcept }, // primary | secondary | exploratory
    "description" : "<markdown>" // Description of the objective
  }],
  "outcomeMeasure" : [{ // An outcome or planned variable to measure during the study
    "name" : "<string>", // Label for the outcome
    "type" : [{ CodeableConcept }], // primary | secondary | exploratory
    "description" : "<markdown>", // Description of the outcome
    "reference" : { Reference(EvidenceVariable) } // Structured outcome definition
  }],
  "result" : [{ Reference(Citation|DiagnosticReport|EvidenceReport) }], // Link to results generated during the study
  "webLocation" : [{ // Archive location for the study
    "type" : { CodeableConcept }, // registry-page|recruitment-page|contact-page 
    "url" : "<uri>" // R!  The location address

  }]
}

Turtle Template 

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:;

[ a fhir:ResearchStudy;

  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:ResearchStudy.url [ uri ]; # 0..1 Canonical identifier for this study resource

  fhir:ResearchStudy.identifier [ Identifier ], ... ; # 0..* Business Identifier for study
  fhir:

  fhir:ResearchStudy.version [ string ]; # 0..1 Business identifier for the study record
  fhir:ResearchStudy.name [ string ]; # 0..1 Name for this study (computer friendly)
  fhir:ResearchStudy.title [ string ]; # 0..1 Name for this study (for computers)
  fhir:ResearchStudy.label [ # 0..* Additional names for the study
    fhir:ResearchStudy.label.type [ CodeableConcept ]; # 0..1 short | public | scientific
    fhir:ResearchStudy.label.value [ string ]; # 0..1 The name
  ], ...;

  fhir:ResearchStudy.protocol [ Reference(PlanDefinition) ], ... ; # 0..* Steps followed in executing study
  fhir:ResearchStudy.partOf [ Reference(ResearchStudy) ], ... ; # 0..* Part of larger study
  fhir:
  fhir:

  fhir:ResearchStudy.relatedArtifact [ RelatedArtifact ], ... ; # 0..* References and dependencies
  fhir:ResearchStudy.date [ dateTime ]; # 0..1 Date the resource last changed
  fhir:ResearchStudy.status [ code ]; # 1..1 draft | active | retired | unknown
  fhir:ResearchStudy.primaryPurposeType [ CodeableConcept ]; # 0..1 treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility

  fhir:ResearchStudy.phase [ CodeableConcept ]; # 0..1 n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  fhir:ResearchStudy.category [ CodeableConcept ], ... ; # 0..* Classifications for the study
  fhir:

  fhir:ResearchStudy.focus [ # 0..* Drugs, devices, etc. under study
    fhir:ResearchStudy.focus.productCode [ CodeableConcept ]; # 0..1 Identification of product under study
    fhir:ResearchStudy.focus.focusType [ CodeableConcept ], ... ; # 0..* medication | device | intervention | factor
    fhir:ResearchStudy.focus.factor [ markdown ]; # 0..1 An independent variable manipulated by the experimentalist
  ], ...;

  fhir:ResearchStudy.condition [ CodeableConcept ], ... ; # 0..* Condition being studied
  fhir:
  fhir:

  fhir:ResearchStudy.keyword [ CodeableConcept ], ... ; # 0..* Used to search for the study
  fhir:ResearchStudy.location [ CodeableConcept ], ... ; # 0..* Geographic region(s) for study
  fhir:
  fhir:

  fhir:ResearchStudy.descriptionSummary [ markdown ]; # 0..1 A brief summary of the study description
  fhir:ResearchStudy.description [ markdown ]; # 0..1 What this is study doing

  fhir:ResearchStudy.period [ Period ]; # 0..1 When the study began and ended
  fhir:ResearchStudy.contact [ ContactDetail ], ... ; # 0..* Contact details for the study

  fhir:ResearchStudy.sponsor [ Reference(Organization) ]; # 0..1 Organization that initiates and is legally responsible for the study
  fhir:ResearchStudy.principalInvestigator [ Reference(Practitioner|PractitionerRole) ]; # 0..1 Researcher who oversees multiple aspects of the study
  fhir:
  fhir:

  fhir:ResearchStudy.site [ Reference(Location|Organization|ResearchStudy) ], ... ; # 0..* Facility where study activities are conducted

  fhir:ResearchStudy.note [ Annotation ], ... ; # 0..* Comments made about the study
  fhir:
    fhir:
    fhir:
    fhir:

  fhir:ResearchStudy.classification [ # 0..* Classification for the study
    fhir:ResearchStudy.classification.type [ CodeableConcept ]; # 0..1 phase | category | keyword 
    fhir:ResearchStudy.classification.classifier [ CodeableConcept ], ... ; # 0..* n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  ], ...;
  fhir:ResearchStudy.associatedParty [ # 0..* Sponsors, collaborators, and other parties
    fhir:ResearchStudy.associatedParty.name [ string ]; # 0..1 Name of associated party
    fhir:ResearchStudy.associatedParty.role [ CodeableConcept ]; # 1..1 sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair
    fhir:ResearchStudy.associatedParty.classifier [ CodeableConcept ], ... ; # 0..* nih | fda
    fhir:ResearchStudy.associatedParty.party [ Reference(Organization|Practitioner|PractitionerRole) ]; # 0..1 Individual or organization associated with study (use practitionerRole to specify their organisation)
  ], ...;
  fhir:ResearchStudy.currentState [ CodeableConcept ], ... ; # 0..* active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  fhir:ResearchStudy.statusDate [ # 0..* Status of study with time for that status
    fhir:ResearchStudy.statusDate.activity [ CodeableConcept ]; # 1..1 Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting
    fhir:ResearchStudy.statusDate.actual [ boolean ]; # 0..1 Actual if true else anticipated
    fhir:ResearchStudy.statusDate.period [ Period ]; # 1..1 Date range
  ], ...;
  fhir:ResearchStudy.whyStopped [ CodeableConcept ]; # 0..1 accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  fhir:ResearchStudy.recruitment [ # 0..1 Target or actual group of participants enrolled in study
    fhir:ResearchStudy.recruitment.targetNumber [ unsignedInt ]; # 0..1 Estimated total number of participants to be enrolled
    fhir:ResearchStudy.recruitment.actualNumber [ unsignedInt ]; # 0..1 Actual total number of participants enrolled in study
    fhir:ResearchStudy.recruitment.eligibility [ Reference(Group) ]; # 0..1 Inclusion and exclusion criteria
    fhir:ResearchStudy.recruitment.actualGroup [ Reference(Group) ]; # 0..1 Group of participants who were enrolled in study
  ];
  fhir:ResearchStudy.comparisonGroup [ # 0..* Defined path through the study for a subject
    # ResearchStudy.comparisonGroup.identifier[x] : 0..1 Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily. One of these 2
      fhir:ResearchStudy.comparisonGroup.identifierUri [ uri ]
      fhir:ResearchStudy.comparisonGroup.identifierIdentifier [ Identifier ]
    fhir:ResearchStudy.comparisonGroup.name [ string ]; # 1..1 Label for study comparisonGroup
    fhir:ResearchStudy.comparisonGroup.type [ CodeableConcept ]; # 0..1 Categorization of study comparisonGroup
    fhir:ResearchStudy.comparisonGroup.description [ markdown ]; # 0..1 Short explanation of study path
    fhir:ResearchStudy.comparisonGroup.intendedExposure [ Reference(EvidenceVariable) ], ... ; # 0..* Interventions or exposures in this comparisonGroup or cohort
    fhir:ResearchStudy.comparisonGroup.observedGroup [ Reference(Group) ]; # 0..1 Group of participants who were enrolled in study comparisonGroup

  ], ...;
  fhir:ResearchStudy.objective [ # 0..* A goal for the study
    fhir:ResearchStudy.objective.name [ string ]; # 0..1 Label for the objective
    fhir:ResearchStudy.objective.type [ CodeableConcept ]; # 0..1 primary | secondary | exploratory
    fhir:ResearchStudy.objective.description [ markdown ]; # 0..1 Description of the objective
  ], ...;
  fhir:ResearchStudy.outcomeMeasure [ # 0..* An outcome or planned variable to measure during the study
    fhir:ResearchStudy.outcomeMeasure.name [ string ]; # 0..1 Label for the outcome
    fhir:ResearchStudy.outcomeMeasure.type [ CodeableConcept ], ... ; # 0..* primary | secondary | exploratory
    fhir:ResearchStudy.outcomeMeasure.description [ markdown ]; # 0..1 Description of the outcome
    fhir:ResearchStudy.outcomeMeasure.reference [ Reference(EvidenceVariable) ]; # 0..1 Structured outcome definition
  ], ...;
  fhir:ResearchStudy.result [ Reference(Citation|DiagnosticReport|EvidenceReport) ], ... ; # 0..* Link to results generated during the study
  fhir:ResearchStudy.webLocation [ # 0..* Archive location for the study
    fhir:ResearchStudy.webLocation.type [ CodeableConcept ]; # 0..1 registry-page|recruitment-page|contact-page
    fhir:ResearchStudy.webLocation.url [ uri ]; # 1..1 The location address

  ], ...;
]

Changes since Release 3

ResearchStudy
ResearchStudy.url
  • Added Element
ResearchStudy.version
  • Added Element
ResearchStudy.name
  • Added Element
ResearchStudy.label
  • Added Element
ResearchStudy.label.type
  • Added Element
ResearchStudy.label.value
  • Added Element
ResearchStudy.date
  • Added Element
ResearchStudy.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-study-status http://hl7.org/fhir/ValueSet/research-study-status|4.0.0 to http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 http://hl7.org/fhir/ValueSet/publication-status|5.0.0-snapshot1
ResearchStudy.focus
  • Type changed from CodeableConcept to BackboneElement
ResearchStudy.primaryPurposeType ResearchStudy.focus.productCode
  • Added Element
ResearchStudy.phase ResearchStudy.focus.focusType
  • Added Element
ResearchStudy.condition ResearchStudy.focus.factor
  • Added Element
ResearchStudy.location ResearchStudy.descriptionSummary
  • Added Element
ResearchStudy.principalInvestigator ResearchStudy.site
  • Type Reference: Added Target Type PractitionerRole Types ResearchStudy, Organization
ResearchStudy.arm.type ResearchStudy.classification
  • Added Element
ResearchStudy.objective ResearchStudy.classification.type
  • Added Element
ResearchStudy.objective.name ResearchStudy.classification.classifier
  • Added Element
ResearchStudy.objective.type ResearchStudy.associatedParty
  • Added Element
ResearchStudy.associatedParty.name
  • Added Element
ResearchStudy.associatedParty.role
  • Added Mandatory Element
ResearchStudy.associatedParty.classifier
  • Added Element
ResearchStudy.associatedParty.party
  • Added Element
ResearchStudy.currentState
  • Added Element
ResearchStudy.statusDate
  • Added Element
ResearchStudy.statusDate.activity
  • Added Mandatory Element
ResearchStudy.statusDate.actual
  • Added Element
ResearchStudy.statusDate.period
  • Added Mandatory Element
ResearchStudy.whyStopped
  • Added Element
ResearchStudy.recruitment
  • Added Element
ResearchStudy.recruitment.targetNumber
  • Added Element
ResearchStudy.recruitment.actualNumber
  • Added Element
ResearchStudy.recruitment.eligibility
  • Added Element
ResearchStudy.recruitment.actualGroup
  • Added Element
ResearchStudy.comparisonGroup
  • Added Element
ResearchStudy.comparisonGroup.identifier[x]
  • Added Element
ResearchStudy.comparisonGroup.name
  • Added Mandatory Element
ResearchStudy.comparisonGroup.type
  • Added Element
ResearchStudy.comparisonGroup.description
  • Added Element
ResearchStudy.comparisonGroup.intendedExposure
  • Added Element
ResearchStudy.comparisonGroup.observedGroup
  • Added Element
ResearchStudy.objective.description
  • Added Element
ResearchStudy.outcomeMeasure
  • Added Element
ResearchStudy.outcomeMeasure.name
  • Added Element
ResearchStudy.outcomeMeasure.type
  • Added Element
ResearchStudy.outcomeMeasure.description
  • Added Element
ResearchStudy.outcomeMeasure.reference
  • Added Element
ResearchStudy.result
  • Added Element
ResearchStudy.webLocation
  • Added Element
ResearchStudy.webLocation.type
  • Added Element
ResearchStudy.webLocation.url
  • Added Mandatory Element
ResearchStudy.jurisdiction ResearchStudy.enrollment
  • deleted
ResearchStudy.arm.code ResearchStudy.reasonStopped
  • deleted
ResearchStudy.arm
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON .

See R3 <--> R4 Conversion Maps (status = 1 test that all execute ok. All tests pass round-trip testing and all r3 resources are valid.)

 

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON , XML Schema / Schematron + JSON Schema , ShEx (for Turtle ) + see the extensions , the spreadsheet version & the dependency analysis a

8.22.2.1 8.22.3.1 Terminology Bindings

Path Definition Type Reference
ResearchStudy.label.type Extensible http://hl7.org/fhir/ValueSet/research-study-title-type
ResearchStudy.status Codes that convey the current status of the research study. Required ResearchStudyStatus PublicationStatus
ResearchStudy.primaryPurposeType Codes for the main intent of the study. Extensible ResearchStudyPrimaryPurposeType
ResearchStudy.phase Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. Example ResearchStudyPhase
ResearchStudy.category Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. Unknown Example No details provided yet ??
ResearchStudy.focus ResearchStudy.focus.productCode Codes for medications, devices and other interventions. Unknown Example No details provided yet ??
ResearchStudy.focus.focusType Extensible http://hl7.org/fhir/ValueSet/research-study-focus-type
ResearchStudy.condition Identification of the condition or diagnosis. Example Condition/Problem/DiagnosisCodes
ResearchStudy.keyword Words associated with the study that may be useful in discovery. Unknown Example No details provided yet ??
ResearchStudy.location Countries and regions within which this artifact is targeted for use. Extensible Jurisdiction ValueSet
ResearchStudy.classification.type Extensible http://hl7.org/fhir/ValueSet/research-study-classification-type
ResearchStudy.classification.classifier Extensible http://hl7.org/fhir/ValueSet/research-study-classification-classifier
ResearchStudy.associatedParty.role Extensible http://hl7.org/fhir/ValueSet/research-study-party-type
ResearchStudy.associatedParty.classifier Extensible http://hl7.org/fhir/ValueSet/research-study-party-org-type
ResearchStudy.currentState Extensible ResearchStudyStatus
ResearchStudy.statusDate.activity Extensible http://hl7.org/fhir/ValueSet/research-study-statusDate-activity
ResearchStudy.reasonStopped ResearchStudy.whyStopped Codes for why the study ended prematurely. Example ResearchStudyReasonStopped
ResearchStudy.comparisonGroup.type Extensible http://hl7.org/fhir/ValueSet/research-study-arm-type
ResearchStudy.objective.type Codes for the kind of study objective. Preferred ResearchStudyObjectiveType
ResearchStudy.outcomeMeasure.type Preferred ResearchStudyObjectiveType
ResearchStudy.webLocation.type Extensible http://hl7.org/fhir/ValueSet/research-study-url-type

8.22.3 8.22.4 ResearchStudy State Machine

The following diagram reflects the "typical" state machine for ResearchStudy.

Diagram showing typical state machine for the ResearchStudy resource

8.22.4 8.22.5 Search Parameters

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
category token Classifications for the study ResearchStudy.category
condition token Condition being studied ResearchStudy.condition
date date When the study began and ended ResearchStudy.period
focus token Drugs, devices, etc. under study ResearchStudy.focus
identifier token Business Identifier for study ResearchStudy.identifier
keyword token Used to search for the study ResearchStudy.keyword
location token Geographic region(s) for study ResearchStudy.location
partof reference Part of larger study ResearchStudy.partOf
( ResearchStudy )
principalinvestigator reference Researcher who oversees multiple aspects of the study ResearchStudy.principalInvestigator
( Practitioner , PractitionerRole )
protocol reference Steps followed in executing study ResearchStudy.protocol
( PlanDefinition )
recruitment_actual number Actual number of participants enrolled in study across all groups ResearchStudy.recruitment.actualNumber
recruitment_target number Target number of participants enrolled in study across all groups ResearchStudy.recruitment.targetNumber
site reference Facility where study activities are conducted ResearchStudy.site
( Organization , Location , ResearchStudy )
sponsor reference Organization that initiates and is legally responsible for the study ResearchStudy.sponsor
( Organization )
status N token active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn ResearchStudy.status
title N string Name for this study ResearchStudy.title