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8.22 8.24 Resource ResearchStudy - Content

Responsible Owner: Regulated Clinical Biomedical Research Information Management and Regulation icon Work Group   Trial Use Maturity Level : 0   Draft Security Category : Business Compartments : Practitioner Group

A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations.

8.24.1 Scope and Usage

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

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.

For clinical trials -- 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
  • Specifying Study information in support of Genomic, Proteomic and Stability studies

8.22.1 8.24.1.1 Scope and Usage Extensions

This resource supports the HL7 mission ResearchStudy is aimed at all forms of studies. For some study types specific extensions have been defined

Extension: SiteRecruitment

Some studies need to create and promote HL7 standards by developing RCRIM standards find sites according to improve or enhance information management during clinical research and regulatory evaluation of the safety, efficacy and quality specific criteria - for example site has a freezer capable of therapeutic products very low temperatures and procedures worldwide. a centrifuge.

This resource is referenced by Extension: StudyRegistration

Used to separate study registration activities from study progress status.

8.24.2 References to this Resource

8.22.2 8.24.3 Resource Content

Structure

0..* Contact details RelatedArtifact Used to search Organization responsible Location involved in Annotation BackboneElement Defined path through the study string
Name Flags Card. Type Description & Constraints      Filter: Filters 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

. . title . version 0..1 Σ string The business version for the study record
0..1
. . . name 0..1 string Name for this study (computer friendly)
. . protocol . title Σ 0..1 string Human readable name of the study
... label 0..* BackboneElement Additional names for the study

.... type 0..1 CodeableConcept primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
Binding: Title Type icon ( Preferred )
.... value 0..1 string The name
.... language 0..1 code Used to express the specific language
Binding: All Languages ( Required )
Additional Bindings Purpose
Common Languages Starter

... protocol Σ 0..* Reference ( PlanDefinition ) Steps followed in executing study

. . . partOf Σ 0..* Reference ( ResearchStudy ) Part of larger study

. . . status citeAs 0..1 ?! markdown How to cite this ResearchStudy
... relatesTo 0..* BackboneElement Relationships to other Resources

.... type 1..1 CodeableConcept documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes
Binding: Artifact Relationship Type icon ( Extensible )
.... target[x] 1..1 The artifact that is related to this ResearchStudy
..... targetUri Σ uri
..... targetAttachment 1..1 Attachment
..... targetCanonical canonical ( Any )
..... targetReference Reference ( Any )
..... targetMarkdown markdown
... date 0..1 dateTime Date the resource last changed
... status ?! Σ 1..1 code draft | in-progress active | suspended retired | stopped unknown
Binding: PublicationStatus ( Required )
... primaryPurposeType Σ 0..1 CodeableConcept treatment | completed prevention | entered-in-error diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType icon ResearchStudyStatus ( Required Preferred )
. . . category phase Σ 0..1 CodeableConcept 0..* Classifier used for clinical trials
Binding: ResearchStudyPhase icon ( Preferred )
... studyDesign Σ 0..* CodeableConcept Classifications for of the study design characteristics
Binding: Study Design ( Preferred )

. . . focus 0..* Σ CodeableReference ( Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition ) Drugs, devices, etc. under study
Binding: Research Study Focus Type ( Example )

. . . condition Σ 0..* CodeableConcept Condition being studied
Binding: Condition/Problem/Diagnosis Codes ( Example )
Drugs, devices, conditions, etc. under study
. . . contact keyword Σ 0..* CodeableConcept ContactDetail Used to search for the study
Binding: Research Study Focus Type ( Example )

. . . region Σ 0..* CodeableConcept Geographic area for the study
Binding: Jurisdiction ValueSet icon ( Preferred )

. . relatedArtifact . descriptionSummary 0..1 markdown 0..* Brief text explaining the study
. . . description References and dependencies 0..1 markdown Detailed narrative of the study
. . . keyword period Σ 0..1 Period When the study began and ended
... site Σ 0..* Reference ( Location | ResearchStudy | Organization ) Facility where study activities are conducted

... note 0..* Annotation Comments made about the study

... classifier 0..* CodeableConcept Classification for the study
Binding: Research Study Classifiers ( Example )

. . . associatedParty 0..* BackboneElement Sponsors, collaborators, and other parties

.... name 0..1 string Name of associated party
. . . . jurisdiction role 1..1 Σ CodeableConcept sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb | data-monitoring
Binding: Research Study Party Role ( Example )
. . . . period 0..* Period When active in the role

.... classifier 0..* CodeableConcept nih | fda | government | nonprofit | academic | industry
Binding: Research Study Party Organization Type ( Example )
Geographic region(s) for
. . . . party 0..1 Reference ( Practitioner | PractitionerRole | Organization ) Individual or organization associated with study (use practitionerRole to specify their organisation)
Jurisdiction ValueSet
. . . progressStatus 0..* BackboneElement Status of study with time for that status

.... state 1..1 CodeableConcept Label for status or state (e.g. recruitment status)
Binding: Research Study Status ( Extensible Example )
. . . . description actual 0..1 boolean Actual if true else anticipated
.... period 0..1 Period markdown Date range
... whyStopped What this is Σ 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Binding: ResearchStudyReasonStopped icon ( Example )
... recruitment Σ 0..1 BackboneElement Target or actual group of participants enrolled in study doing
. . . enrollment . targetNumber 0..1 Σ unsignedInt Estimated total number of participants to be enrolled
0..*
. . . . actualNumber 0..1 unsignedInt Actual total number of participants enrolled in study
.... eligibility 0..1 Reference ( Group ) Inclusion & and exclusion criteria
. . . period . actualGroup Σ 0..1 Reference ( Group ) Group of participants who were enrolled in study
.... description 0..1 markdown Period Description of the recruitment
... comparisonGroup When 0..* BackboneElement Defined path through the study began and ended for a subject

. . . sponsor . targetNumber 0..1 Σ unsignedInt Estimated total number of participants to be enrolled in the comparison group
. . . . actualNumber 0..1 unsignedInt Actual total number of participants enrolled in the comparison group
.... eligibility 0..1 Reference ( Organization Group ) Inclusion and exclusion criteria for the study comparison group
. . . principalInvestigator . observedGroup 0..1 Σ Reference ( Group ) Group of participants who were enrolled in the comparison group
. . . . description 0..1 markdown Reference Description of the comparison Group
... objective ( Practitioner ) The individual responsible 0..* BackboneElement A goal for the study

. . . site . name 0..1 Σ string Label for the objective
0..*
. . . . type 0..1 CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType icon Reference ( Location Preferred )
. . . . description 0..1 markdown Description of the objective
.... outcomeMeasure 0..* BackboneElement A variable measured during the study execution

. . . . reasonStopped . name 0..1 Σ string Label for the outcome measure
0..1
. . . . . type 0..1 CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType icon ( Preferred )
Reason for terminating study early
. . . . note . description 0..1 markdown 0..* Description of the outcome measure
. . . . . endpoint Comments made about 1..1 Reference ( EvidenceVariable ) Definition of the event outcome measure
. . arm . . . population 0..1 0..* Reference ( Group ) Population for this estimand
. . . . . intervention 0..1 Reference ( Group ) Comparison group of interest
. . . . . comparator 0..1 Reference ( Group ) Comparison group for a subject comparison
. . . . name . summaryMeasure 0..1 CodeableConcept Statistical measure for treatment effect estimate
Binding: StatisticStatisticType icon ( Example )
1..1
. . . . . endpointAnalysisPlan Label 0..1 Reference ( Evidence ) Statistical analysis plan for study arm a single endpoint
. . . . . eventHandling 0..* BackboneElement Handling of intercurrent event

... . . . code event 0..1 CodeableConcept The event
...... group 0..1 CodeableConcept The group that is affected by this event handling
...... handling 0..1 CodeableConcept How the data is handled
Categorization of study arm
. . . . . . description 0..1 markdown string Text summary of event handling
... result Short explanation of Σ 0..* Reference ( Composition | DiagnosticReport | Evidence ) Link to results generated during the study path


doco Documentation for this format icon

See the Extensions for this resource

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..*] A short, descriptive user-friendly label The business version for the study record version : string [0..1] Name for this study (computer friendly) name : string [0..1] The human readable name of the research study 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 » Display of the bibliographic citation of this ResearchStudy citeAs : markdown [0..1] The current date (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes date : dateTime [0..1] The publication state of the study resource (not of the study) (this element modifies the meaning of other elements) status : code [1..1] « null (Strength=Required) PublicationStatus ! » Codes that convey The type of study based upon the current status intent of the study activities. A classification of the intent of the research study (Strength=Required) ResearchStudyStatus ! primaryPurposeType : CodeableConcept [0..1] « null (Strength=Preferred) 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] « null (Strength=Preferred) ResearchStudyPhase ? » Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc category studyDesign : CodeableConcept [0..*] « null (Strength=Preferred) StudyDesign ? » The condition(s), medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about focus : CodeableConcept CodeableReference [0..*] « Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition ; Contact details to assist a user in learning more about or engaging with the study null (Strength=Example) contact : ContactDetail ResearchStudyFocusType [0..*] ?? » Citations, references and other related documents 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 relatedArtifact condition : RelatedArtifact CodeableConcept [0..*] « null (Strength=Example) ConditionProblemDiagnosisCodes ?? » Key terms to aid in searching for or filtering the study keyword : CodeableConcept [0..*] « null (Strength=Example) ResearchStudyFocusType ?? » Indicates a A country, state or other region area where the study is taking place rather than its precise geographic location or address jurisdiction region : CodeableConcept [0..*] « Countries and regions within which this artifact is targeted for use (Strength=Extensible) null (Strength=Preferred) Jurisdiction ValueSet JurisdictionValueSet + ? » A full description of how brief text for explaining the study is being conducted description descriptionSummary : markdown [0..1] Reference to a Group that defines the criteria for A detailed and quantity human-readable narrative of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes" E.g., study abstract 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] The organization responsible for A facility in which study activities are conducted site : Reference [0..*] « Location | ResearchStudy | Organization » Comments made about the execution study by the performer, subject or other participants note : Annotation [0..*] Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource classifier : CodeableConcept [0..*] « null (Strength=Example) ResearchStudyClassifiers ?? » A description and/or code explaining the premature termination of the study sponsor whyStopped : CodeableConcept [0..1] « null (Strength=Example) ResearchStudyReasonStopped ?? » Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov result : Reference [0..*] « Composition | DiagnosticReport | Evidence » Label Kind of name type : CodeableConcept [0..1] Organization « null (Strength=Preferred) TitleType ? » Indicates The name value : string [0..1] Used to express the individual who has primary oversite specific language of the execution title language : code [0..1] « null (Strength=Required) AllLanguages ! » RelatesTo The type of relationship to the related artifact type : CodeableConcept [1..1] « null (Strength=Extensible) ArtifactRelationshipType + » The artifact that is related to this ResearchStudy Resource target[x] : DataType [1..1] « uri | Attachment | canonical ( Any )| Reference ( Any )| markdown » AssociatedParty Name of associated party name : string [0..1] Type of association role : CodeableConcept [1..1] « null (Strength=Example) ResearchStudyPartyRole ?? » Identifies the start date and the end date of the associated party in the role period : Period [0..*] A categorization other than role for the associated party classifier : CodeableConcept [0..*] « null (Strength=Example) ResearchStudyPartyOrgType ?? » Individual or organization associated with study (use practitionerRole to specify their organisation) principalInvestigator party : Reference [0..1] « Practitioner | PractitionerRole | Organization » ProgressStatus Clinic, hospital Label for status or other healthcare location that state (e.g. recruitment status) state : CodeableConcept [1..1] « null (Strength=Example) ResearchStudyStatus ?? » An indication of whether or not the date is participating in a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date actual : boolean [0..1] Date range period : Period [0..1] Recruitment Estimated total number of participants to be enrolled targetNumber : unsignedInt [0..1] Actual total number of participants enrolled in study site actualNumber : unsignedInt [0..1] Inclusion and exclusion criteria. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual' eligibility : Reference [0..*] Location [0..1] « Group » A Group of participants who were enrolled in study. The referenced Group Resource should have a membership element value of 'enumerated' actualGroup : Reference [0..1] « Group » Free text description and/or code explaining of the premature termination recruitment of the study reasonStopped description : CodeableConcept markdown [0..1] ComparisonGroup Comments made about Estimated total number of participants to be enrolled in the event by comparison group targetNumber : unsignedInt [0..1] Actual total number of participants enrolled in the performer, subject comparison group actualNumber : unsignedInt [0..1] Inclusion and exclusion criteria for the comparison group as a subset of the eligibility for the overall study. The referenced Group Resource should have a membership element value of either 'definitional' or other 'conceptual' eligibility : Reference [0..1] « Group » Group of participants who were enrolled in the comparison group as a subset of those enrolled in the overall study. The referenced Group Resource should have a membership element value of 'enumerated' note observedGroup : Annotation Reference [0..*] [0..1] « Group » Description of the comparison Group description : markdown [0..1] Arm Objective Unique, human-readable label for this arm objective of the study name : string [1..1] [0..1] Categorization The kind of study arm, e.g. experimental, active comparator, placebo comparater objective code type : CodeableConcept [0..1] « null (Strength=Preferred) ResearchStudyObjectiveType ? » A succinct Free text description of the path through objective of the study. This is what the study that would be followed by a subject adhering is trying to this arm achieve rather than how it is going to achieve it (see ResearchStudy.description) description : markdown [0..1] OutcomeMeasure Label for the outcome measure name : string [0..1] The kind of outcome measure type : CodeableConcept [0..1] « null (Strength=Preferred) ResearchStudyObjectiveType ? » Description of the outcome measure description : markdown [0..1] Definition of the outcome measure endpoint : Reference [1..1] « EvidenceVariable » Population for this estimand population : Reference [0..1] « Group » Comparison group of interest intervention : Reference [0..1] « Group » Comparison group for comparison comparator : Reference [0..1] « Group » Statistical measure for treatment effect estimate summaryMeasure : CodeableConcept [0..1] « null (Strength=Example) StatisticStatisticType ?? » The planned statistical model for analysis of a single endpoint endpointAnalysisPlan : Reference [0..1] « Evidence » EventHandling The event event : CodeableConcept [0..1] The group that is affected by this event handling group : CodeableConcept [0..1] How the data is handled handling : CodeableConcept [0..1] Text summary of event handling description : markdown [0..1] Additional names for the study label [0..*] Sponsors, collaborators, and other parties associatedParty [0..*] Status of study with time for that status progressStatus [0..*] Target or actual group of participants enrolled in study recruitment [0..1] Describes an expected event or sequence of events for one of the participants subjects of a study. E.g. Exposure for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month} arm comparisonGroup [0..*] Handling of intercurrent event eventHandling [0..*] An "outcome measure", "endpoint", "effect measure" or "measure of effect" is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment outcomeMeasure [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..*]

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 The business version for the study record -->
 <name value="[string]"/><!-- 0..1 Name for this study (computer friendly) -->
 <title value="[string]"/><!-- 0..1 Human readable name of the study -->
 <label>  <!-- 0..* Additional names for the study -->
  <type><!-- 0..1 CodeableConcept primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid icon --></type>
  <value value="[string]"/><!-- 0..1 The name -->
  <language value="[code]"/><!-- 0..1 Used to express the specific language -->
 </label>

 <protocol><!-- 0..* Reference(PlanDefinition) Steps followed in executing study --></protocol>
 <partOf><!-- 0..* Reference(ResearchStudy) Part of larger study --></partOf>
 <
 <</category>
 <</focus>
 <</contact>
 <</relatedArtifact>
 <</keyword>
 <</jurisdiction>
 <
 <</enrollment>

 <citeAs value="[markdown]"/><!-- 0..1 How to cite this ResearchStudy -->
 <relatesTo>  <!-- 0..* Relationships to other Resources -->
  <type><!-- 1..1 CodeableConcept documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes icon --></type>
  <target[x]><!-- 1..1 uri|Attachment|canonical(Any)|Reference(Any)|markdown The artifact that is related to this ResearchStudy --></target[x]>
 </relatesTo>
 <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 icon --></primaryPurposeType>
 <phase><!-- 0..1 CodeableConcept Classifier used for clinical trials icon --></phase>
 <studyDesign><!-- 0..* CodeableConcept Classifications of the study design characteristics --></studyDesign>
 <focus><!-- 0..* CodeableReference(DeviceDefinition|Medication|
   MedicinalProductDefinition|PlanDefinition|SubstanceDefinition) Drugs, devices, etc. under study --></focus>

 <condition><!-- 0..* CodeableConcept Condition being studied --></condition>
 <keyword><!-- 0..* CodeableConcept Used to search for the study --></keyword>
 <region><!-- 0..* CodeableConcept Geographic area for the study icon --></region>
 <descriptionSummary value="[markdown]"/><!-- 0..1 Brief text explaining the study -->
 <description value="[markdown]"/><!-- 0..1 Detailed narrative of the study -->

 <period><!-- 0..1 Period When the study began and ended --></period>
 <</sponsor>
 <</principalInvestigator>
 <</site>
 <</reasonStopped>
 <</note>
 <
  <
  <</code>
  <
 </arm>

 <site><!-- 0..* Reference(Location|Organization|ResearchStudy) Facility where study activities are conducted --></site>
 <note><!-- 0..* Annotation Comments made about the study --></note>
 <classifier><!-- 0..* CodeableConcept Classification for the study --></classifier>
 <associatedParty>  <!-- 0..* Sponsors, collaborators, and other parties -->
  <name value="[string]"/><!-- 0..1 Name of associated party -->
  <role><!-- 1..1 CodeableConcept sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb | data-monitoring --></role>
  <period><!-- 0..* Period When active in the role --></period>
  <classifier><!-- 0..* CodeableConcept nih | fda | government | nonprofit | academic | industry --></classifier>
  <party><!-- 0..1 Reference(Organization|Practitioner|PractitionerRole) Individual or organization associated with study (use practitionerRole to specify their organisation) --></party>
 </associatedParty>
 <progressStatus>  <!-- 0..* Status of study with time for that status -->
  <state><!-- 1..1 CodeableConcept Label for status or state (e.g. recruitment status) --></state>
  <actual value="[boolean]"/><!-- 0..1 Actual if true else anticipated -->
  <period><!-- 0..1 Period Date range --></period>
 </progressStatus>
 <whyStopped><!-- 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design icon --></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>
  <description value="[markdown]"/><!-- 0..1 Description of the recruitment -->
 </recruitment>
 <comparisonGroup>  <!-- 0..* Defined path through the study for a subject -->
  <targetNumber value="[unsignedInt]"/><!-- 0..1 Estimated total number of participants to be enrolled in the comparison group -->
  <actualNumber value="[unsignedInt]"/><!-- 0..1 Actual total number of participants enrolled in the comparison group -->
  <eligibility><!-- 0..1 Reference(Group) Inclusion and exclusion criteria for the comparison group --></eligibility>
  <observedGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in the comparison group --></observedGroup>
  <description value="[markdown]"/><!-- 0..1 Description of the comparison Group -->
 </comparisonGroup>
 <objective>  <!-- 0..* A goal for the study -->
  <name value="[string]"/><!-- 0..1 Label for the objective -->
  <type><!-- 0..1 CodeableConcept primary | secondary | exploratory icon --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the objective -->
  <outcomeMeasure>  <!-- 0..* A variable measured during the study -->
   <name value="[string]"/><!-- 0..1 Label for the outcome measure -->
   <type><!-- 0..1 CodeableConcept primary | secondary | exploratory icon --></type>
   <description value="[markdown]"/><!-- 0..1 Description of the outcome measure -->
   <endpoint><!-- 1..1 Reference(EvidenceVariable) Definition of the outcome measure --></endpoint>
   <population><!-- 0..1 Reference(Group) Population for this estimand --></population>
   <intervention><!-- 0..1 Reference(Group) Comparison group of interest --></intervention>
   <comparator><!-- 0..1 Reference(Group) Comparison group for comparison --></comparator>
   <summaryMeasure><!-- 0..1 CodeableConcept Statistical measure for treatment effect estimate icon --></summaryMeasure>
   <endpointAnalysisPlan><!-- 0..1 Reference(Evidence) Statistical analysis plan for a single endpoint --></endpointAnalysisPlan>
   <eventHandling>  <!-- 0..* Handling of intercurrent event -->
    <event><!-- 0..1 CodeableConcept The event --></event>
    <group><!-- 0..1 CodeableConcept The group that is affected by this event handling --></group>
    <handling><!-- 0..1 CodeableConcept How the data is handled --></handling>
    <description value="[markdown]"/><!-- 0..1 Text summary of event handling -->
   </eventHandling>
  </outcomeMeasure>
 </objective>
 <result><!-- 0..* Reference(Composition|DiagnosticReport|Evidence) Link to results generated during the study --></result>

</ResearchStudy>

JSON Template 

{doco
  "resourceType" : "",

  "resourceType" : "ResearchStudy",

  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "
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  }]

  "url" : "<uri>", // Canonical identifier for this study resource
  "identifier" : [{ Identifier }], // Business Identifier for study
  "version" : "<string>", // The business version for the study record
  "name" : "<string>", // Name for this study (computer friendly)
  "title" : "<string>", // Human readable name of the study
  "label" : [{ // Additional names for the study
    "type" : { CodeableConcept }, // primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid icon
    "value" : "<string>", // The name
    "language" : "<code>" // Used to express the specific language
  }],
  "protocol" : [{ Reference(PlanDefinition) }], // Steps followed in executing study
  "partOf" : [{ Reference(ResearchStudy) }], // Part of larger study
  "citeAs" : "<markdown>", // How to cite this ResearchStudy
  "relatesTo" : [{ // Relationships to other Resources
    "type" : { CodeableConcept }, // R!  documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes icon
    // target[x]: The artifact that is related to this ResearchStudy. One of these 5:

    "targetUri" : "<uri>",
    "targetAttachment" : { Attachment },
    "targetCanonical" : "<canonical(Any)>",
    "targetReference" : { Reference(Any) },
    "targetMarkdown" : "<markdown>"
  }],
  "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 icon
  "phase" : { CodeableConcept }, // Classifier used for clinical trials icon
  "studyDesign" : [{ CodeableConcept }], // Classifications of the study design characteristics
  "focus" : [{ CodeableReference(DeviceDefinition|Medication|
   MedicinalProductDefinition|PlanDefinition|SubstanceDefinition) }], // Drugs, devices, etc. under study

  "condition" : [{ CodeableConcept }], // Condition being studied
  "keyword" : [{ CodeableConcept }], // Used to search for the study
  "region" : [{ CodeableConcept }], // Geographic area for the study icon
  "descriptionSummary" : "<markdown>", // Brief text explaining the study
  "description" : "<markdown>", // Detailed narrative of the study
  "period" : { Period }, // When the study began and ended
  "site" : [{ Reference(Location|Organization|ResearchStudy) }], // Facility where study activities are conducted
  "note" : [{ Annotation }], // Comments made about the study
  "classifier" : [{ CodeableConcept }], // Classification for the study
  "associatedParty" : [{ // Sponsors, collaborators, and other parties
    "name" : "<string>", // Name of associated party
    "role" : { CodeableConcept }, // R!  sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb | data-monitoring
    "period" : [{ Period }], // When active in the role
    "classifier" : [{ CodeableConcept }], // nih | fda | government | nonprofit | academic | industry
    "party" : { Reference(Organization|Practitioner|PractitionerRole) } // Individual or organization associated with study (use practitionerRole to specify their organisation)
  }],
  "progressStatus" : [{ // Status of study with time for that status
    "state" : { CodeableConcept }, // R!  Label for status or state (e.g. recruitment status)
    "actual" : <boolean>, // Actual if true else anticipated
    "period" : { Period } // Date range
  }],
  "whyStopped" : { CodeableConcept }, // accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design icon
  "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
    "description" : "<markdown>" // Description of the recruitment
  },
  "comparisonGroup" : [{ // Defined path through the study for a subject
    "targetNumber" : "<unsignedInt>", // Estimated total number of participants to be enrolled in the comparison group
    "actualNumber" : "<unsignedInt>", // Actual total number of participants enrolled in the comparison group
    "eligibility" : { Reference(Group) }, // Inclusion and exclusion criteria for the comparison group
    "observedGroup" : { Reference(Group) }, // Group of participants who were enrolled in the comparison group
    "description" : "<markdown>" // Description of the comparison Group
  }],
  "objective" : [{ // A goal for the study
    "name" : "<string>", // Label for the objective
    "type" : { CodeableConcept }, // primary | secondary | exploratory icon
    "description" : "<markdown>", // Description of the objective
    "outcomeMeasure" : [{ // A variable measured during the study
      "name" : "<string>", // Label for the outcome measure
      "type" : { CodeableConcept }, // primary | secondary | exploratory icon
      "description" : "<markdown>", // Description of the outcome measure
      "endpoint" : { Reference(EvidenceVariable) }, // R!  Definition of the outcome measure
      "population" : { Reference(Group) }, // Population for this estimand
      "intervention" : { Reference(Group) }, // Comparison group of interest
      "comparator" : { Reference(Group) }, // Comparison group for comparison
      "summaryMeasure" : { CodeableConcept }, // Statistical measure for treatment effect estimate icon
      "endpointAnalysisPlan" : { Reference(Evidence) }, // Statistical analysis plan for a single endpoint
      "eventHandling" : [{ // Handling of intercurrent event
        "event" : { CodeableConcept }, // The event
        "group" : { CodeableConcept }, // The group that is affected by this event handling
        "handling" : { CodeableConcept }, // How the data is handled
        "description" : "<markdown>" // Text summary of event handling
      }]
    }]
  }],
  "result" : [{ Reference(Composition|DiagnosticReport|Evidence) }] // Link to results generated during the study

}

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 
  # from 
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
    fhir:
    fhir:
    fhir:
  ], ...;

  # from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language
  # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir:modifierExtension
  fhir:url [ uri ] ; # 0..1 Canonical identifier for this study resource
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Business Identifier for study
  fhir:version [ string ] ; # 0..1 The business version for the study record
  fhir:name [ string ] ; # 0..1 Name for this study (computer friendly)
  fhir:title [ string ] ; # 0..1 Human readable name of the study
  fhir:label ( [ # 0..* Additional names for the study
    fhir:type [ CodeableConcept ] ; # 0..1 primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
    fhir:value [ string ] ; # 0..1 The name
    fhir:language [ code ] ; # 0..1 Used to express the specific language
  ] ... ) ;
  fhir:protocol  ( [ Reference(PlanDefinition) ] ... ) ; # 0..* Steps followed in executing study
  fhir:partOf  ( [ Reference(ResearchStudy) ] ... ) ; # 0..* Part of larger study
  fhir:citeAs [ markdown ] ; # 0..1 How to cite this ResearchStudy
  fhir:relatesTo ( [ # 0..* Relationships to other Resources
    fhir:type [ CodeableConcept ] ; # 1..1 documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes
    # target[x] : 1..1 The artifact that is related to this ResearchStudy. One of these 5
      fhir:target [  a fhir:Uri ; uri ]
      fhir:target [  a fhir:Attachment ; Attachment ]
      fhir:target [  a fhir:Canonical ; canonical(Any) ]
      fhir:target [  a fhir:Reference ; Reference(Any) ]
      fhir:target [  a fhir:Markdown ; markdown ]
  ] ... ) ;
  fhir:date [ dateTime ] ; # 0..1 Date the resource last changed
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown
  fhir:primaryPurposeType [ CodeableConcept ] ; # 0..1 treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
  fhir:phase [ CodeableConcept ] ; # 0..1 Classifier used for clinical trials
  fhir:studyDesign  ( [ CodeableConcept ] ... ) ; # 0..* Classifications of the study design characteristics
  fhir:focus  ( [ CodeableReference(DeviceDefinition|Medication|MedicinalProductDefinition|PlanDefinition|
  SubstanceDefinition) ] ... ) ; # 0..* Drugs, devices, etc. under study

  fhir:condition  ( [ CodeableConcept ] ... ) ; # 0..* Condition being studied
  fhir:keyword  ( [ CodeableConcept ] ... ) ; # 0..* Used to search for the study
  fhir:region  ( [ CodeableConcept ] ... ) ; # 0..* Geographic area for the study
  fhir:descriptionSummary [ markdown ] ; # 0..1 Brief text explaining the study
  fhir:description [ markdown ] ; # 0..1 Detailed narrative of the study
  fhir:period [ Period ] ; # 0..1 When the study began and ended
  fhir:site  ( [ Reference(Location|Organization|ResearchStudy) ] ... ) ; # 0..* Facility where study activities are conducted
  fhir:note  ( [ Annotation ] ... ) ; # 0..* Comments made about the study
  fhir:classifier  ( [ CodeableConcept ] ... ) ; # 0..* Classification for the study
  fhir:associatedParty ( [ # 0..* Sponsors, collaborators, and other parties
    fhir:name [ string ] ; # 0..1 Name of associated party
    fhir:role [ CodeableConcept ] ; # 1..1 sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb | data-monitoring
    fhir:period  ( [ Period ] ... ) ; # 0..* When active in the role
    fhir:classifier  ( [ CodeableConcept ] ... ) ; # 0..* nih | fda | government | nonprofit | academic | industry
    fhir:party [ Reference(Organization|Practitioner|PractitionerRole) ] ; # 0..1 Individual or organization associated with study (use practitionerRole to specify their organisation)
  ] ... ) ;
  fhir:progressStatus ( [ # 0..* Status of study with time for that status
    fhir:state [ CodeableConcept ] ; # 1..1 Label for status or state (e.g. recruitment status)
    fhir:actual [ boolean ] ; # 0..1 Actual if true else anticipated
    fhir:period [ Period ] ; # 0..1 Date range
  ] ... ) ;
  fhir:whyStopped [ CodeableConcept ] ; # 0..1 accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  fhir:recruitment [ # 0..1 Target or actual group of participants enrolled in study
    fhir:targetNumber [ unsignedInt ] ; # 0..1 Estimated total number of participants to be enrolled
    fhir:actualNumber [ unsignedInt ] ; # 0..1 Actual total number of participants enrolled in study
    fhir:eligibility [ Reference(Group) ] ; # 0..1 Inclusion and exclusion criteria
    fhir:actualGroup [ Reference(Group) ] ; # 0..1 Group of participants who were enrolled in study
    fhir:description [ markdown ] ; # 0..1 Description of the recruitment
  ] ;
  fhir:comparisonGroup ( [ # 0..* Defined path through the study for a subject
    fhir:targetNumber [ unsignedInt ] ; # 0..1 Estimated total number of participants to be enrolled in the comparison group
    fhir:actualNumber [ unsignedInt ] ; # 0..1 Actual total number of participants enrolled in the comparison group
    fhir:eligibility [ Reference(Group) ] ; # 0..1 Inclusion and exclusion criteria for the comparison group
    fhir:observedGroup [ Reference(Group) ] ; # 0..1 Group of participants who were enrolled in the comparison group
    fhir:description [ markdown ] ; # 0..1 Description of the comparison Group
  ] ... ) ;
  fhir:objective ( [ # 0..* A goal for the study
    fhir:name [ string ] ; # 0..1 Label for the objective
    fhir:type [ CodeableConcept ] ; # 0..1 primary | secondary | exploratory
    fhir:description [ markdown ] ; # 0..1 Description of the objective
    fhir:outcomeMeasure ( [ # 0..* A variable measured during the study
      fhir:name [ string ] ; # 0..1 Label for the outcome measure
      fhir:type [ CodeableConcept ] ; # 0..1 primary | secondary | exploratory
      fhir:description [ markdown ] ; # 0..1 Description of the outcome measure
      fhir:endpoint [ Reference(EvidenceVariable) ] ; # 1..1 Definition of the outcome measure
      fhir:population [ Reference(Group) ] ; # 0..1 Population for this estimand
      fhir:intervention [ Reference(Group) ] ; # 0..1 Comparison group of interest
      fhir:comparator [ Reference(Group) ] ; # 0..1 Comparison group for comparison
      fhir:summaryMeasure [ CodeableConcept ] ; # 0..1 Statistical measure for treatment effect estimate
      fhir:endpointAnalysisPlan [ Reference(Evidence) ] ; # 0..1 Statistical analysis plan for a single endpoint
      fhir:eventHandling ( [ # 0..* Handling of intercurrent event
        fhir:event [ CodeableConcept ] ; # 0..1 The event
        fhir:group [ CodeableConcept ] ; # 0..1 The group that is affected by this event handling
        fhir:handling [ CodeableConcept ] ; # 0..1 How the data is handled
        fhir:description [ markdown ] ; # 0..1 Text summary of event handling
      ] ... ) ;
    ] ... ) ;
  ] ... ) ;
  fhir:result  ( [ Reference(Composition|DiagnosticReport|Evidence) ] ... ) ; # 0..* Link to results generated during the study

]

Changes since DSTU2 from both R4 and R4B

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.label.language
  • Added Element
ResearchStudy.citeAs
  • Added Element
ResearchStudy.relatesTo
  • Added Element
ResearchStudy.relatesTo.type
  • Added Mandatory Element
ResearchStudy.relatesTo.target[x]
  • Added Mandatory Element
ResearchStudy.date
  • Added Element
ResearchStudy.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-study-status|4.0.0 to PublicationStatus
  • Remove codes 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
  • Add codes draft , retired , unknown
ResearchStudy.primaryPurposeType
  • Remove Binding `http://hl7.org/fhir/ValueSet/research-study-prim-purp-type` (extensible)
ResearchStudy.studyDesign
  • Added Element
ResearchStudy.focus
  • Type changed from CodeableConcept to CodeableReference
ResearchStudy.region
  • Added Element
ResearchStudy.descriptionSummary
  • Added Element
ResearchStudy.site
  • Type Reference: Added Target Types ResearchStudy, Organization
ResearchStudy.classifier
  • Added Element
ResearchStudy.associatedParty
  • Added Element
ResearchStudy.associatedParty.name
  • Added Element
ResearchStudy.associatedParty.role
  • Added Mandatory Element
ResearchStudy.associatedParty.period
  • Added Element
ResearchStudy.associatedParty.classifier
  • Added Element
ResearchStudy.associatedParty.party
  • Added Element
ResearchStudy.progressStatus
  • Added Element
ResearchStudy.progressStatus.state
  • Added Mandatory Element
ResearchStudy.progressStatus.actual
  • Added Element
ResearchStudy.progressStatus.period
  • Added 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.recruitment.description
  • Added Element
ResearchStudy.comparisonGroup
  • Added Element
ResearchStudy.comparisonGroup.targetNumber
  • Added Element
ResearchStudy.comparisonGroup.actualNumber
  • Added Element
ResearchStudy.comparisonGroup.eligibility
  • Added Element
ResearchStudy.comparisonGroup.observedGroup
  • Added Element
ResearchStudy.comparisonGroup.description
  • Added Element
ResearchStudy.objective.description
  • Added Element
ResearchStudy.objective.outcomeMeasure
  • Added Element
ResearchStudy.objective.outcomeMeasure.name
  • Added Element
ResearchStudy.objective.outcomeMeasure.type
  • Added Element
ResearchStudy.objective.outcomeMeasure.description
  • Added Element
ResearchStudy.objective.outcomeMeasure.endpoint
  • Added Mandatory Element
ResearchStudy.objective.outcomeMeasure.population
  • Added Element
ResearchStudy.objective.outcomeMeasure.intervention
  • Added Element
ResearchStudy.objective.outcomeMeasure.comparator
  • Added Element
ResearchStudy.objective.outcomeMeasure.summaryMeasure
  • Added Element
ResearchStudy.objective.outcomeMeasure.endpointAnalysisPlan
  • Added Element
ResearchStudy.objective.outcomeMeasure.eventHandling
  • Added Element
ResearchStudy.objective.outcomeMeasure.eventHandling.event
  • Added Element
ResearchStudy.objective.outcomeMeasure.eventHandling.group
  • Added Element
ResearchStudy.objective.outcomeMeasure.eventHandling.handling
  • Added Element
ResearchStudy.objective.outcomeMeasure.eventHandling.description
  • Added Element
ResearchStudy.result
  • Added Element
ResearchStudy.category
  • Deleted
ResearchStudy.contact
  • Deleted
ResearchStudy.relatedArtifact
  • Deleted
ResearchStudy.location
  • Deleted
ResearchStudy.enrollment
  • Deleted
ResearchStudy.sponsor
  • Deleted
ResearchStudy.principalInvestigator
  • Deleted
ResearchStudy.reasonStopped
  • Deleted
ResearchStudy.arm
  • Deleted

This resource did not exist in Release 2 See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON .

Structure

0..* Contact details RelatedArtifact Used to search Organization responsible Location involved in Annotation BackboneElement
Name Flags Card. Type Description & Constraints      Filter: Filters 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

. . title . version 0..1 Σ string The business version for the study record
0..1
. . . name 0..1 string Name for this study (computer friendly)
. . protocol . title Σ 0..1 string Human readable name of the study
... label 0..* BackboneElement Additional names for the study

.... type 0..1 CodeableConcept primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
Binding: Title Type icon ( Preferred )
.... value 0..1 string The name
.... language 0..1 code Used to express the specific language
Binding: All Languages ( Required )
Additional Bindings Purpose
Common Languages Starter

... protocol Σ 0..* Reference ( PlanDefinition ) Steps followed in executing study

. . . partOf Σ 0..* Reference ( ResearchStudy ) Part of larger study

. . . status citeAs 0..1 ?! markdown How to cite this ResearchStudy
... relatesTo 0..* BackboneElement Relationships to other Resources

.... type 1..1 CodeableConcept documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes
Binding: Artifact Relationship Type icon ( Extensible )
.... target[x] 1..1 The artifact that is related to this ResearchStudy
..... targetUri Σ uri
..... targetAttachment 1..1 Attachment
..... targetCanonical canonical ( Any )
..... targetReference Reference ( Any )
..... targetMarkdown markdown
... date 0..1 dateTime Date the resource last changed
... status ?! Σ 1..1 code draft | in-progress active | suspended retired | stopped unknown
Binding: PublicationStatus ( Required )
... primaryPurposeType Σ 0..1 CodeableConcept treatment | completed prevention | entered-in-error diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType icon ResearchStudyStatus ( Required Preferred )
. . . category phase Σ 0..1 CodeableConcept 0..* Classifier used for clinical trials
Binding: ResearchStudyPhase icon ( Preferred )
... studyDesign Σ 0..* CodeableConcept Classifications for of the study design characteristics
Binding: Study Design ( Preferred )

. . . focus 0..* Σ CodeableReference ( Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition ) Drugs, devices, etc. under study
Binding: Research Study Focus Type ( Example )

. . . condition Σ 0..* CodeableConcept Condition being studied
Binding: Condition/Problem/Diagnosis Codes ( Example )
Drugs, devices, conditions, etc. under study
. . . contact keyword Σ 0..* CodeableConcept ContactDetail Used to search for the study
Binding: Research Study Focus Type ( Example )

. . . region Σ 0..* CodeableConcept Geographic area for the study
Binding: Jurisdiction ValueSet icon ( Preferred )

. . relatedArtifact . descriptionSummary 0..1 markdown 0..* Brief text explaining the study
. . . description References and dependencies 0..1 markdown Detailed narrative of the study
. . . keyword period Σ 0..1 Period When the study began and ended
... site Σ 0..* Reference ( Location | ResearchStudy | Organization ) Facility where study activities are conducted

... note 0..* Annotation Comments made about the study

... classifier 0..* CodeableConcept Classification for the study
Binding: Research Study Classifiers ( Example )

. . . associatedParty 0..* BackboneElement Sponsors, collaborators, and other parties

. . . . name 0..1 string Name of associated party
.. . . jurisdiction role 1..1 Σ CodeableConcept sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb | data-monitoring
Binding: Research Study Party Role ( Example )
. . . . period 0..* Period When active in the role

.... classifier 0..* CodeableConcept nih | fda | government | nonprofit | academic | industry
Binding: Research Study Party Organization Type ( Example )
Geographic region(s) for
. . . . party 0..1 Reference ( Practitioner | PractitionerRole | Organization ) Individual or organization associated with study (use practitionerRole to specify their organisation)
Jurisdiction ValueSet
. . . progressStatus 0..* BackboneElement Status of study with time for that status

.... state 1..1 CodeableConcept Label for status or state (e.g. recruitment status)
Binding: Research Study Status ( Extensible Example )
. . . . description actual 0..1 boolean Actual if true else anticipated
.... period 0..1 Period markdown Date range
... whyStopped What this is Σ 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Binding: ResearchStudyReasonStopped icon ( Example )
... recruitment Σ 0..1 BackboneElement Target or actual group of participants enrolled in study doing
. . . enrollment . targetNumber 0..1 Σ unsignedInt Estimated total number of participants to be enrolled
0..*
. . . . actualNumber 0..1 unsignedInt Actual total number of participants enrolled in study
.... eligibility 0..1 Reference ( Group ) Inclusion & and exclusion criteria
. . . period . actualGroup Σ 0..1 Reference ( Group ) Group of participants who were enrolled in study
.... description 0..1 markdown Period Description of the recruitment
... comparisonGroup When 0..* BackboneElement Defined path through the study began and ended for a subject

. . . sponsor . targetNumber 0..1 Σ unsignedInt Estimated total number of participants to be enrolled in the comparison group
. . . . actualNumber 0..1 unsignedInt Actual total number of participants enrolled in the comparison group
.... eligibility 0..1 Reference ( Organization Group ) Inclusion and exclusion criteria for the study comparison group
. . . principalInvestigator . observedGroup 0..1 Σ Reference ( Group ) Group of participants who were enrolled in the comparison group
. . . . description 0..1 markdown Reference Description of the comparison Group
... objective ( Practitioner ) The individual responsible 0..* BackboneElement A goal for the study

. . . site . name 0..1 Σ string Label for the objective
0..*
. . . . type 0..1 CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType icon Reference ( Location Preferred )
. . . . description 0..1 markdown Description of the objective
.... outcomeMeasure 0..* BackboneElement A variable measured during the study execution

. . . . reasonStopped . name 0..1 Σ string Label for the outcome measure
0..1
. . . . . type 0..1 CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType icon ( Preferred )
Reason for terminating study early
. . . . note . description 0..1 markdown 0..* Description of the outcome measure
. . . . . endpoint Comments made about 1..1 Reference ( EvidenceVariable ) Definition of the event outcome measure
. . arm . . . population 0..1 0..* Reference ( Group ) Population for this estimand
. . . . . intervention Defined path through the study 0..1 Reference ( Group ) Comparison group of interest
..... comparator 0..1 Reference ( Group ) Comparison group for a subject comparison
. . . . name . summaryMeasure 0..1 CodeableConcept 1..1 Statistical measure for treatment effect estimate
Binding: StatisticStatisticType icon ( Example )
string
. . . . . endpointAnalysisPlan Label 0..1 Reference ( Evidence ) Statistical analysis plan for study arm a single endpoint
. . . . . eventHandling 0..* BackboneElement Handling of intercurrent event

... . . . code event 0..1 CodeableConcept The event
...... group 0..1 CodeableConcept The group that is affected by this event handling
...... handling 0..1 CodeableConcept How the data is handled
Categorization of study arm
. . . . . . description 0..1 markdown string Text summary of event handling
... result Short explanation of Σ 0..* Reference ( Composition | DiagnosticReport | Evidence ) Link to results generated during the study path


doco Documentation for this format icon

See the Extensions for this resource

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..*] A short, descriptive user-friendly label The business version for the study record version : string [0..1] Name for this study (computer friendly) name : string [0..1] The human readable name of the research study 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 » Display of the bibliographic citation of this ResearchStudy citeAs : markdown [0..1] The current date (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes date : dateTime [0..1] The publication state of the study resource (not of the study) (this element modifies the meaning of other elements) status : code [1..1] « null (Strength=Required) PublicationStatus ! » Codes that convey The type of study based upon the current status intent of the study activities. A classification of the intent of the research study (Strength=Required) ResearchStudyStatus ! primaryPurposeType : CodeableConcept [0..1] « null (Strength=Preferred) 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] « null (Strength=Preferred) ResearchStudyPhase ? » Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc category studyDesign : CodeableConcept [0..*] « null (Strength=Preferred) StudyDesign ? » The condition(s), medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about focus : CodeableConcept CodeableReference [0..*] « Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition ; Contact details to assist a user in learning more about or engaging with the study null (Strength=Example) contact : ContactDetail ResearchStudyFocusType [0..*] ?? » Citations, references and other related documents 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 relatedArtifact condition : RelatedArtifact CodeableConcept [0..*] « null (Strength=Example) ConditionProblemDiagnosisCodes ?? » Key terms to aid in searching for or filtering the study keyword : CodeableConcept [0..*] « null (Strength=Example) ResearchStudyFocusType ?? » Indicates a A country, state or other region area where the study is taking place rather than its precise geographic location or address jurisdiction region : CodeableConcept [0..*] « Countries and regions within which this artifact is targeted for use (Strength=Extensible) null (Strength=Preferred) Jurisdiction ValueSet JurisdictionValueSet + ? » A full description of how brief text for explaining the study is being conducted description descriptionSummary : markdown [0..1] Reference to a Group that defines the criteria for A detailed and quantity human-readable narrative of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes" E.g., study abstract 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] The organization responsible for A facility in which study activities are conducted site : Reference [0..*] « Location | ResearchStudy | Organization » Comments made about the execution study by the performer, subject or other participants note : Annotation [0..*] Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource classifier : CodeableConcept [0..*] « null (Strength=Example) ResearchStudyClassifiers ?? » A description and/or code explaining the premature termination of the study sponsor whyStopped : CodeableConcept [0..1] « null (Strength=Example) ResearchStudyReasonStopped ?? » Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov result : Reference [0..*] « Composition | DiagnosticReport | Evidence » Label Kind of name type : CodeableConcept [0..1] Organization « null (Strength=Preferred) TitleType ? » Indicates The name value : string [0..1] Used to express the individual who has primary oversite specific language of the execution title language : code [0..1] « null (Strength=Required) AllLanguages ! » RelatesTo The type of relationship to the related artifact type : CodeableConcept [1..1] « null (Strength=Extensible) ArtifactRelationshipType + » The artifact that is related to this ResearchStudy Resource target[x] : DataType [1..1] « uri | Attachment | canonical ( Any )| Reference ( Any )| markdown » AssociatedParty Name of associated party name : string [0..1] Type of association role : CodeableConcept [1..1] « null (Strength=Example) ResearchStudyPartyRole ?? » Identifies the start date and the end date of the associated party in the role period : Period [0..*] A categorization other than role for the associated party classifier : CodeableConcept [0..*] « null (Strength=Example) ResearchStudyPartyOrgType ?? » Individual or organization associated with study (use practitionerRole to specify their organisation) principalInvestigator party : Reference [0..1] « Practitioner | PractitionerRole | Organization » ProgressStatus Clinic, hospital Label for status or other healthcare location that state (e.g. recruitment status) state : CodeableConcept [1..1] « null (Strength=Example) ResearchStudyStatus ?? » An indication of whether or not the date is participating in a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date actual : boolean [0..1] Date range period : Period [0..1] Recruitment Estimated total number of participants to be enrolled targetNumber : unsignedInt [0..1] Actual total number of participants enrolled in study site actualNumber : unsignedInt [0..1] Inclusion and exclusion criteria. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual' eligibility : Reference [0..*] Location [0..1] « Group » A Group of participants who were enrolled in study. The referenced Group Resource should have a membership element value of 'enumerated' actualGroup : Reference [0..1] « Group » Free text description and/or code explaining of the premature termination recruitment of the study reasonStopped description : CodeableConcept markdown [0..1] ComparisonGroup Comments made about Estimated total number of participants to be enrolled in the event by comparison group targetNumber : unsignedInt [0..1] Actual total number of participants enrolled in the performer, subject comparison group actualNumber : unsignedInt [0..1] Inclusion and exclusion criteria for the comparison group as a subset of the eligibility for the overall study. The referenced Group Resource should have a membership element value of either 'definitional' or other 'conceptual' eligibility : Reference [0..1] « Group » Group of participants who were enrolled in the comparison group as a subset of those enrolled in the overall study. The referenced Group Resource should have a membership element value of 'enumerated' note observedGroup : Annotation Reference [0..*] [0..1] « Group » Description of the comparison Group description : markdown [0..1] Arm Objective Unique, human-readable label for this arm objective of the study name : string [1..1] [0..1] Categorization The kind of study arm, e.g. experimental, active comparator, placebo comparater objective code type : CodeableConcept [0..1] « null (Strength=Preferred) ResearchStudyObjectiveType ? » A succinct Free text description of the path through objective of the study. This is what the study that would be followed by a subject adhering is trying to this arm achieve rather than how it is going to achieve it (see ResearchStudy.description) description : markdown [0..1] OutcomeMeasure Label for the outcome measure name : string [0..1] The kind of outcome measure type : CodeableConcept [0..1] « null (Strength=Preferred) ResearchStudyObjectiveType ? » Description of the outcome measure description : markdown [0..1] Definition of the outcome measure endpoint : Reference [1..1] « EvidenceVariable » Population for this estimand population : Reference [0..1] « Group » Comparison group of interest intervention : Reference [0..1] « Group » Comparison group for comparison comparator : Reference [0..1] « Group » Statistical measure for treatment effect estimate summaryMeasure : CodeableConcept [0..1] « null (Strength=Example) StatisticStatisticType ?? » The planned statistical model for analysis of a single endpoint endpointAnalysisPlan : Reference [0..1] « Evidence » EventHandling The event event : CodeableConcept [0..1] The group that is affected by this event handling group : CodeableConcept [0..1] How the data is handled handling : CodeableConcept [0..1] Text summary of event handling description : markdown [0..1] Additional names for the study label [0..*] Sponsors, collaborators, and other parties associatedParty [0..*] Status of study with time for that status progressStatus [0..*] Target or actual group of participants enrolled in study recruitment [0..1] Describes an expected event or sequence of events for one of the participants subjects of a study. E.g. Exposure for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month} arm comparisonGroup [0..*] Handling of intercurrent event eventHandling [0..*] An "outcome measure", "endpoint", "effect measure" or "measure of effect" is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment outcomeMeasure [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..*]

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 The business version for the study record -->
 <name value="[string]"/><!-- 0..1 Name for this study (computer friendly) -->
 <title value="[string]"/><!-- 0..1 Human readable name of the study -->
 <label>  <!-- 0..* Additional names for the study -->
  <type><!-- 0..1 CodeableConcept primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid icon --></type>
  <value value="[string]"/><!-- 0..1 The name -->
  <language value="[code]"/><!-- 0..1 Used to express the specific language -->
 </label>

 <protocol><!-- 0..* Reference(PlanDefinition) Steps followed in executing study --></protocol>
 <partOf><!-- 0..* Reference(ResearchStudy) Part of larger study --></partOf>
 <
 <</category>
 <</focus>
 <</contact>
 <</relatedArtifact>
 <</keyword>
 <</jurisdiction>
 <
 <</enrollment>

 <citeAs value="[markdown]"/><!-- 0..1 How to cite this ResearchStudy -->
 <relatesTo>  <!-- 0..* Relationships to other Resources -->
  <type><!-- 1..1 CodeableConcept documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes icon --></type>
  <target[x]><!-- 1..1 uri|Attachment|canonical(Any)|Reference(Any)|markdown The artifact that is related to this ResearchStudy --></target[x]>
 </relatesTo>
 <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 icon --></primaryPurposeType>
 <phase><!-- 0..1 CodeableConcept Classifier used for clinical trials icon --></phase>
 <studyDesign><!-- 0..* CodeableConcept Classifications of the study design characteristics --></studyDesign>
 <focus><!-- 0..* CodeableReference(DeviceDefinition|Medication|
   MedicinalProductDefinition|PlanDefinition|SubstanceDefinition) Drugs, devices, etc. under study --></focus>

 <condition><!-- 0..* CodeableConcept Condition being studied --></condition>
 <keyword><!-- 0..* CodeableConcept Used to search for the study --></keyword>
 <region><!-- 0..* CodeableConcept Geographic area for the study icon --></region>
 <descriptionSummary value="[markdown]"/><!-- 0..1 Brief text explaining the study -->
 <description value="[markdown]"/><!-- 0..1 Detailed narrative of the study -->

 <period><!-- 0..1 Period When the study began and ended --></period>
 <</sponsor>
 <</principalInvestigator>
 <</site>
 <</reasonStopped>
 <</note>
 <
  <
  <</code>
  <
 </arm>

 <site><!-- 0..* Reference(Location|Organization|ResearchStudy) Facility where study activities are conducted --></site>
 <note><!-- 0..* Annotation Comments made about the study --></note>
 <classifier><!-- 0..* CodeableConcept Classification for the study --></classifier>
 <associatedParty>  <!-- 0..* Sponsors, collaborators, and other parties -->
  <name value="[string]"/><!-- 0..1 Name of associated party -->
  <role><!-- 1..1 CodeableConcept sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb | data-monitoring --></role>
  <period><!-- 0..* Period When active in the role --></period>
  <classifier><!-- 0..* CodeableConcept nih | fda | government | nonprofit | academic | industry --></classifier>
  <party><!-- 0..1 Reference(Organization|Practitioner|PractitionerRole) Individual or organization associated with study (use practitionerRole to specify their organisation) --></party>
 </associatedParty>
 <progressStatus>  <!-- 0..* Status of study with time for that status -->
  <state><!-- 1..1 CodeableConcept Label for status or state (e.g. recruitment status) --></state>
  <actual value="[boolean]"/><!-- 0..1 Actual if true else anticipated -->
  <period><!-- 0..1 Period Date range --></period>
 </progressStatus>
 <whyStopped><!-- 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design icon --></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>
  <description value="[markdown]"/><!-- 0..1 Description of the recruitment -->
 </recruitment>
 <comparisonGroup>  <!-- 0..* Defined path through the study for a subject -->
  <targetNumber value="[unsignedInt]"/><!-- 0..1 Estimated total number of participants to be enrolled in the comparison group -->
  <actualNumber value="[unsignedInt]"/><!-- 0..1 Actual total number of participants enrolled in the comparison group -->
  <eligibility><!-- 0..1 Reference(Group) Inclusion and exclusion criteria for the comparison group --></eligibility>
  <observedGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in the comparison group --></observedGroup>
  <description value="[markdown]"/><!-- 0..1 Description of the comparison Group -->
 </comparisonGroup>
 <objective>  <!-- 0..* A goal for the study -->
  <name value="[string]"/><!-- 0..1 Label for the objective -->
  <type><!-- 0..1 CodeableConcept primary | secondary | exploratory icon --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the objective -->
  <outcomeMeasure>  <!-- 0..* A variable measured during the study -->
   <name value="[string]"/><!-- 0..1 Label for the outcome measure -->
   <type><!-- 0..1 CodeableConcept primary | secondary | exploratory icon --></type>
   <description value="[markdown]"/><!-- 0..1 Description of the outcome measure -->
   <endpoint><!-- 1..1 Reference(EvidenceVariable) Definition of the outcome measure --></endpoint>
   <population><!-- 0..1 Reference(Group) Population for this estimand --></population>
   <intervention><!-- 0..1 Reference(Group) Comparison group of interest --></intervention>
   <comparator><!-- 0..1 Reference(Group) Comparison group for comparison --></comparator>
   <summaryMeasure><!-- 0..1 CodeableConcept Statistical measure for treatment effect estimate icon --></summaryMeasure>
   <endpointAnalysisPlan><!-- 0..1 Reference(Evidence) Statistical analysis plan for a single endpoint --></endpointAnalysisPlan>
   <eventHandling>  <!-- 0..* Handling of intercurrent event -->
    <event><!-- 0..1 CodeableConcept The event --></event>
    <group><!-- 0..1 CodeableConcept The group that is affected by this event handling --></group>
    <handling><!-- 0..1 CodeableConcept How the data is handled --></handling>
    <description value="[markdown]"/><!-- 0..1 Text summary of event handling -->
   </eventHandling>
  </outcomeMeasure>
 </objective>
 <result><!-- 0..* Reference(Composition|DiagnosticReport|Evidence) Link to results generated during the study --></result>

</ResearchStudy>

JSON Template 

{doco
  "resourceType" : "",

  "resourceType" : "ResearchStudy",

  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "
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    "
  }]

  "url" : "<uri>", // Canonical identifier for this study resource
  "identifier" : [{ Identifier }], // Business Identifier for study
  "version" : "<string>", // The business version for the study record
  "name" : "<string>", // Name for this study (computer friendly)
  "title" : "<string>", // Human readable name of the study
  "label" : [{ // Additional names for the study
    "type" : { CodeableConcept }, // primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid icon
    "value" : "<string>", // The name
    "language" : "<code>" // Used to express the specific language
  }],
  "protocol" : [{ Reference(PlanDefinition) }], // Steps followed in executing study
  "partOf" : [{ Reference(ResearchStudy) }], // Part of larger study
  "citeAs" : "<markdown>", // How to cite this ResearchStudy
  "relatesTo" : [{ // Relationships to other Resources
    "type" : { CodeableConcept }, // R!  documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes icon
    // target[x]: The artifact that is related to this ResearchStudy. One of these 5:

    "targetUri" : "<uri>",
    "targetAttachment" : { Attachment },
    "targetCanonical" : "<canonical(Any)>",
    "targetReference" : { Reference(Any) },
    "targetMarkdown" : "<markdown>"
  }],
  "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 icon
  "phase" : { CodeableConcept }, // Classifier used for clinical trials icon
  "studyDesign" : [{ CodeableConcept }], // Classifications of the study design characteristics
  "focus" : [{ CodeableReference(DeviceDefinition|Medication|
   MedicinalProductDefinition|PlanDefinition|SubstanceDefinition) }], // Drugs, devices, etc. under study

  "condition" : [{ CodeableConcept }], // Condition being studied
  "keyword" : [{ CodeableConcept }], // Used to search for the study
  "region" : [{ CodeableConcept }], // Geographic area for the study icon
  "descriptionSummary" : "<markdown>", // Brief text explaining the study
  "description" : "<markdown>", // Detailed narrative of the study
  "period" : { Period }, // When the study began and ended
  "site" : [{ Reference(Location|Organization|ResearchStudy) }], // Facility where study activities are conducted
  "note" : [{ Annotation }], // Comments made about the study
  "classifier" : [{ CodeableConcept }], // Classification for the study
  "associatedParty" : [{ // Sponsors, collaborators, and other parties
    "name" : "<string>", // Name of associated party
    "role" : { CodeableConcept }, // R!  sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb | data-monitoring
    "period" : [{ Period }], // When active in the role
    "classifier" : [{ CodeableConcept }], // nih | fda | government | nonprofit | academic | industry
    "party" : { Reference(Organization|Practitioner|PractitionerRole) } // Individual or organization associated with study (use practitionerRole to specify their organisation)
  }],
  "progressStatus" : [{ // Status of study with time for that status
    "state" : { CodeableConcept }, // R!  Label for status or state (e.g. recruitment status)
    "actual" : <boolean>, // Actual if true else anticipated
    "period" : { Period } // Date range
  }],
  "whyStopped" : { CodeableConcept }, // accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design icon
  "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
    "description" : "<markdown>" // Description of the recruitment
  },
  "comparisonGroup" : [{ // Defined path through the study for a subject
    "targetNumber" : "<unsignedInt>", // Estimated total number of participants to be enrolled in the comparison group
    "actualNumber" : "<unsignedInt>", // Actual total number of participants enrolled in the comparison group
    "eligibility" : { Reference(Group) }, // Inclusion and exclusion criteria for the comparison group
    "observedGroup" : { Reference(Group) }, // Group of participants who were enrolled in the comparison group
    "description" : "<markdown>" // Description of the comparison Group
  }],
  "objective" : [{ // A goal for the study
    "name" : "<string>", // Label for the objective
    "type" : { CodeableConcept }, // primary | secondary | exploratory icon
    "description" : "<markdown>", // Description of the objective
    "outcomeMeasure" : [{ // A variable measured during the study
      "name" : "<string>", // Label for the outcome measure
      "type" : { CodeableConcept }, // primary | secondary | exploratory icon
      "description" : "<markdown>", // Description of the outcome measure
      "endpoint" : { Reference(EvidenceVariable) }, // R!  Definition of the outcome measure
      "population" : { Reference(Group) }, // Population for this estimand
      "intervention" : { Reference(Group) }, // Comparison group of interest
      "comparator" : { Reference(Group) }, // Comparison group for comparison
      "summaryMeasure" : { CodeableConcept }, // Statistical measure for treatment effect estimate icon
      "endpointAnalysisPlan" : { Reference(Evidence) }, // Statistical analysis plan for a single endpoint
      "eventHandling" : [{ // Handling of intercurrent event
        "event" : { CodeableConcept }, // The event
        "group" : { CodeableConcept }, // The group that is affected by this event handling
        "handling" : { CodeableConcept }, // How the data is handled
        "description" : "<markdown>" // Text summary of event handling
      }]
    }]
  }],
  "result" : [{ Reference(Composition|DiagnosticReport|Evidence) }] // Link to results generated during the study

}

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 
  # from 
  fhir:
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  ], ...;

  # from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language
  # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir:modifierExtension
  fhir:url [ uri ] ; # 0..1 Canonical identifier for this study resource
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Business Identifier for study
  fhir:version [ string ] ; # 0..1 The business version for the study record
  fhir:name [ string ] ; # 0..1 Name for this study (computer friendly)
  fhir:title [ string ] ; # 0..1 Human readable name of the study
  fhir:label ( [ # 0..* Additional names for the study
    fhir:type [ CodeableConcept ] ; # 0..1 primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
    fhir:value [ string ] ; # 0..1 The name
    fhir:language [ code ] ; # 0..1 Used to express the specific language
  ] ... ) ;
  fhir:protocol  ( [ Reference(PlanDefinition) ] ... ) ; # 0..* Steps followed in executing study
  fhir:partOf  ( [ Reference(ResearchStudy) ] ... ) ; # 0..* Part of larger study
  fhir:citeAs [ markdown ] ; # 0..1 How to cite this ResearchStudy
  fhir:relatesTo ( [ # 0..* Relationships to other Resources
    fhir:type [ CodeableConcept ] ; # 1..1 documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes
    # target[x] : 1..1 The artifact that is related to this ResearchStudy. One of these 5
      fhir:target [  a fhir:Uri ; uri ]
      fhir:target [  a fhir:Attachment ; Attachment ]
      fhir:target [  a fhir:Canonical ; canonical(Any) ]
      fhir:target [  a fhir:Reference ; Reference(Any) ]
      fhir:target [  a fhir:Markdown ; markdown ]
  ] ... ) ;
  fhir:date [ dateTime ] ; # 0..1 Date the resource last changed
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown
  fhir:primaryPurposeType [ CodeableConcept ] ; # 0..1 treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
  fhir:phase [ CodeableConcept ] ; # 0..1 Classifier used for clinical trials
  fhir:studyDesign  ( [ CodeableConcept ] ... ) ; # 0..* Classifications of the study design characteristics
  fhir:focus  ( [ CodeableReference(DeviceDefinition|Medication|MedicinalProductDefinition|PlanDefinition|
  SubstanceDefinition) ] ... ) ; # 0..* Drugs, devices, etc. under study

  fhir:condition  ( [ CodeableConcept ] ... ) ; # 0..* Condition being studied
  fhir:keyword  ( [ CodeableConcept ] ... ) ; # 0..* Used to search for the study
  fhir:region  ( [ CodeableConcept ] ... ) ; # 0..* Geographic area for the study
  fhir:descriptionSummary [ markdown ] ; # 0..1 Brief text explaining the study
  fhir:description [ markdown ] ; # 0..1 Detailed narrative of the study
  fhir:period [ Period ] ; # 0..1 When the study began and ended
  fhir:site  ( [ Reference(Location|Organization|ResearchStudy) ] ... ) ; # 0..* Facility where study activities are conducted
  fhir:note  ( [ Annotation ] ... ) ; # 0..* Comments made about the study
  fhir:classifier  ( [ CodeableConcept ] ... ) ; # 0..* Classification for the study
  fhir:associatedParty ( [ # 0..* Sponsors, collaborators, and other parties
    fhir:name [ string ] ; # 0..1 Name of associated party
    fhir:role [ CodeableConcept ] ; # 1..1 sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb | data-monitoring
    fhir:period  ( [ Period ] ... ) ; # 0..* When active in the role
    fhir:classifier  ( [ CodeableConcept ] ... ) ; # 0..* nih | fda | government | nonprofit | academic | industry
    fhir:party [ Reference(Organization|Practitioner|PractitionerRole) ] ; # 0..1 Individual or organization associated with study (use practitionerRole to specify their organisation)
  ] ... ) ;
  fhir:progressStatus ( [ # 0..* Status of study with time for that status
    fhir:state [ CodeableConcept ] ; # 1..1 Label for status or state (e.g. recruitment status)
    fhir:actual [ boolean ] ; # 0..1 Actual if true else anticipated
    fhir:period [ Period ] ; # 0..1 Date range
  ] ... ) ;
  fhir:whyStopped [ CodeableConcept ] ; # 0..1 accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  fhir:recruitment [ # 0..1 Target or actual group of participants enrolled in study
    fhir:targetNumber [ unsignedInt ] ; # 0..1 Estimated total number of participants to be enrolled
    fhir:actualNumber [ unsignedInt ] ; # 0..1 Actual total number of participants enrolled in study
    fhir:eligibility [ Reference(Group) ] ; # 0..1 Inclusion and exclusion criteria
    fhir:actualGroup [ Reference(Group) ] ; # 0..1 Group of participants who were enrolled in study
    fhir:description [ markdown ] ; # 0..1 Description of the recruitment
  ] ;
  fhir:comparisonGroup ( [ # 0..* Defined path through the study for a subject
    fhir:targetNumber [ unsignedInt ] ; # 0..1 Estimated total number of participants to be enrolled in the comparison group
    fhir:actualNumber [ unsignedInt ] ; # 0..1 Actual total number of participants enrolled in the comparison group
    fhir:eligibility [ Reference(Group) ] ; # 0..1 Inclusion and exclusion criteria for the comparison group
    fhir:observedGroup [ Reference(Group) ] ; # 0..1 Group of participants who were enrolled in the comparison group
    fhir:description [ markdown ] ; # 0..1 Description of the comparison Group
  ] ... ) ;
  fhir:objective ( [ # 0..* A goal for the study
    fhir:name [ string ] ; # 0..1 Label for the objective
    fhir:type [ CodeableConcept ] ; # 0..1 primary | secondary | exploratory
    fhir:description [ markdown ] ; # 0..1 Description of the objective
    fhir:outcomeMeasure ( [ # 0..* A variable measured during the study
      fhir:name [ string ] ; # 0..1 Label for the outcome measure
      fhir:type [ CodeableConcept ] ; # 0..1 primary | secondary | exploratory
      fhir:description [ markdown ] ; # 0..1 Description of the outcome measure
      fhir:endpoint [ Reference(EvidenceVariable) ] ; # 1..1 Definition of the outcome measure
      fhir:population [ Reference(Group) ] ; # 0..1 Population for this estimand
      fhir:intervention [ Reference(Group) ] ; # 0..1 Comparison group of interest
      fhir:comparator [ Reference(Group) ] ; # 0..1 Comparison group for comparison
      fhir:summaryMeasure [ CodeableConcept ] ; # 0..1 Statistical measure for treatment effect estimate
      fhir:endpointAnalysisPlan [ Reference(Evidence) ] ; # 0..1 Statistical analysis plan for a single endpoint
      fhir:eventHandling ( [ # 0..* Handling of intercurrent event
        fhir:event [ CodeableConcept ] ; # 0..1 The event
        fhir:group [ CodeableConcept ] ; # 0..1 The group that is affected by this event handling
        fhir:handling [ CodeableConcept ] ; # 0..1 How the data is handled
        fhir:description [ markdown ] ; # 0..1 Text summary of event handling
      ] ... ) ;
    ] ... ) ;
  ] ... ) ;
  fhir:result  ( [ Reference(Composition|DiagnosticReport|Evidence) ] ... ) ; # 0..* Link to results generated during the study

]

Changes since DSTU2 from both R4 and R4B

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.label.language
  • Added Element
ResearchStudy.citeAs
  • Added Element
ResearchStudy.relatesTo
  • Added Element
ResearchStudy.relatesTo.type
  • Added Mandatory Element
ResearchStudy.relatesTo.target[x]
  • Added Mandatory Element
ResearchStudy.date
  • Added Element
ResearchStudy.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-study-status|4.0.0 to PublicationStatus
  • Remove codes 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
  • Add codes draft , retired , unknown
ResearchStudy.primaryPurposeType
  • Remove Binding `http://hl7.org/fhir/ValueSet/research-study-prim-purp-type` (extensible)
ResearchStudy.studyDesign
  • Added Element
ResearchStudy.focus
  • Type changed from CodeableConcept to CodeableReference
ResearchStudy.region
  • Added Element
ResearchStudy.descriptionSummary
  • Added Element
ResearchStudy.site
  • Type Reference: Added Target Types ResearchStudy, Organization
ResearchStudy.classifier
  • Added Element
ResearchStudy.associatedParty
  • Added Element
ResearchStudy.associatedParty.name
  • Added Element
ResearchStudy.associatedParty.role
  • Added Mandatory Element
ResearchStudy.associatedParty.period
  • Added Element
ResearchStudy.associatedParty.classifier
  • Added Element
ResearchStudy.associatedParty.party
  • Added Element
ResearchStudy.progressStatus
  • Added Element
ResearchStudy.progressStatus.state
  • Added Mandatory Element
ResearchStudy.progressStatus.actual
  • Added Element
ResearchStudy.progressStatus.period
  • Added 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.recruitment.description
  • Added Element
ResearchStudy.comparisonGroup
  • Added Element
ResearchStudy.comparisonGroup.targetNumber
  • Added Element
ResearchStudy.comparisonGroup.actualNumber
  • Added Element
ResearchStudy.comparisonGroup.eligibility
  • Added Element
ResearchStudy.comparisonGroup.observedGroup
  • Added Element
ResearchStudy.comparisonGroup.description
  • Added Element
ResearchStudy.objective.description
  • Added Element
ResearchStudy.objective.outcomeMeasure
  • Added Element
ResearchStudy.objective.outcomeMeasure.name
  • Added Element
ResearchStudy.objective.outcomeMeasure.type
  • Added Element
ResearchStudy.objective.outcomeMeasure.description
  • Added Element
ResearchStudy.objective.outcomeMeasure.endpoint
  • Added Mandatory Element
ResearchStudy.objective.outcomeMeasure.population
  • Added Element
ResearchStudy.objective.outcomeMeasure.intervention
  • Added Element
ResearchStudy.objective.outcomeMeasure.comparator
  • Added Element
ResearchStudy.objective.outcomeMeasure.summaryMeasure
  • Added Element
ResearchStudy.objective.outcomeMeasure.endpointAnalysisPlan
  • Added Element
ResearchStudy.objective.outcomeMeasure.eventHandling
  • Added Element
ResearchStudy.objective.outcomeMeasure.eventHandling.event
  • Added Element
ResearchStudy.objective.outcomeMeasure.eventHandling.group
  • Added Element
ResearchStudy.objective.outcomeMeasure.eventHandling.handling
  • Added Element
ResearchStudy.objective.outcomeMeasure.eventHandling.description
  • Added Element
ResearchStudy.result
  • Added Element
ResearchStudy.category
  • Deleted
ResearchStudy.contact
  • Deleted
ResearchStudy.relatedArtifact
  • Deleted
ResearchStudy.location
  • Deleted
ResearchStudy.enrollment
  • Deleted
ResearchStudy.sponsor
  • Deleted
ResearchStudy.principalInvestigator
  • Deleted
ResearchStudy.reasonStopped
  • Deleted
ResearchStudy.arm
  • Deleted

This resource did not exist in Release 2 See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON .

 

Alternate Additional definitions: Master Definition ( XML , + JSON ), , XML Schema / Schematron (for ) + JSON Schema , ShEx (for Turtle ) + see the extensions , the spreadsheet version & the dependency analysis

8.22.2.1 8.24.3.1 Terminology Bindings

ResearchStudy.status ResearchStudy.category Unknown ResearchStudy.focus ResearchStudy.jurisdiction
Path Definition ValueSet Type Reference Documentation
ResearchStudy.label.type TitleType icon Preferred Codes that convey

Used to express the current status of reason and specific aspect for the research study variant title, such as language and specific language.

ResearchStudy.label.language AllLanguages (a valid code from Tags for the Identification of Languages icon ) Required

This value set includes all possible codes from BCP-47 (see http://tools.ietf.org/html/bcp47)

  Common Languages starter
ResearchStudy.relatesTo.type ResearchStudyStatus ArtifactRelationshipType icon Extensible

Type of relationship to the related artifact.

ResearchStudy.status PublicationStatus Required

The lifecycle status of an artifact.

ResearchStudy.primaryPurposeType ResearchStudyPrimaryPurposeType icon Preferred

Codes that describe for the type main intent of research the study. E.g. Study phase, Interventional/Observational, blinding type, etc.

ResearchStudy.phase ResearchStudyPhase icon Preferred No details provided yet

Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

ResearchStudy.studyDesign StudyDesign Preferred Codes

This is a set of terms for medications, devices, conditions and other interventions study design characteristics.

ResearchStudy.focus ResearchStudyFocusType Unknown Example

Some example codes of research study focus

ResearchStudy.condition No details provided yet ConditionProblemDiagnosisCodes Example

Example value set for Condition/Problem/Diagnosis codes.

ResearchStudy.keyword ResearchStudyFocusType Example Words associated with the

Some example codes of research study that may focus

ResearchStudy.region JurisdictionValueSet icon Preferred

This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be useful in discovery used.

Note: The codes for countries and country subdivisions are taken from ISO 3166 icon while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) icon.

ResearchStudy.classifier ResearchStudyClassifiers (a valid code from ResearchStudy Classifiers Code System ) Unknown Example

Codes that convey the type of label that is provided.

ResearchStudy.associatedParty.role No details provided yet ResearchStudyPartyRole Example

This is a ResearchStudy's party role.

ResearchStudy.associatedParty.classifier ResearchStudyPartyOrgType (a valid code from ResearchStudy Party Organization Type Code System ) Example Countries and regions within which this artifact

This is targeted a ResearchStudy's party organization type.

ResearchStudy.progressStatus.state ResearchStudyStatus Example

Codes that convey the current status of the research study.

ResearchStudy.whyStopped ResearchStudyReasonStopped icon Example

Codes for use why the study ended prematurely.

ResearchStudy.objective.type ResearchStudyObjectiveType icon Extensible Preferred

Codes for the kind of study objective.

ResearchStudy.objective.outcomeMeasure.type Jurisdiction ValueSet ResearchStudyObjectiveType icon Preferred

Codes for the kind of study objective.

ResearchStudy.objective.outcomeMeasure.summaryMeasure StatisticStatisticType icon Example

The type of a specific statistic.



8.24.4 ResearchStudy State Machine

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

Diagram showing typical state machine for the ResearchStudy resource

8.22.3 8.24.5 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource , and check the Extensions registry for search parameters on extensions related to 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
classifier category token Classifications Classification for the study ResearchStudy.category ResearchStudy.classifier
condition token Condition being studied ResearchStudy.condition
date date When the study began and ended ResearchStudy.period
description string focus Detailed narrative of the study ResearchStudy.description
eligibility reference Inclusion and exclusion criteria ResearchStudy.recruitment.eligibility
( Group )
focus-code token Drugs, devices, conditions, etc. under study study, as a code ResearchStudy.focus ResearchStudy.focus.concept
focus-reference reference Drugs, devices, etc. under study, as a reference ResearchStudy.focus.reference
identifier token Business Identifier for study ResearchStudy.identifier
jurisdiction keyword token Geographic region(s) Used to search for the study ResearchStudy.jurisdiction ResearchStudy.keyword
keyword name string Name for this study ResearchStudy.name token
objective-description string Used to search for Free text description of the objective of the study ResearchStudy.keyword ResearchStudy.objective.description
objective-type token partof The kind of study objective ResearchStudy.objective.type
part-of reference Part of larger study ResearchStudy.partOf
( ResearchStudy )
phase token principalinvestigator The stage in the progression of a study ResearchStudy.phase
progress-actual reference token Actual if true else anticipated ResearchStudy.progressStatus.actual
progress-period The individual responsible date Date range ResearchStudy.progressStatus.period
progress-state token Label for the study status or state ResearchStudy.progressStatus.state
progress-status-state-actual ResearchStudy.principalInvestigator composite Status of study by state and actual On ResearchStudy.progressStatus:
( Practitioner   progress-state: progress-state
  progress-actual: progress-actual
) progress-status-state-period composite Status of study by state and period On ResearchStudy.progressStatus:
  progress-state: progress-state
  progress-period: progress-period
progress-status-state-period-actual composite Status of study by state, period and actual On ResearchStudy.progressStatus:
  progress-state: progress-state
  progress-period: progress-period
  progress-actual: progress-actual
protocol reference Steps followed in executing study ResearchStudy.protocol
( PlanDefinition )
recruitment-actual site reference number Location involved Actual number of participants enrolled in study execution across all groups ResearchStudy.recruitment.actualNumber
recruitment-target ResearchStudy.site ( Location number ) Target number of participants enrolled in study across all groups ResearchStudy.recruitment.targetNumber
region token sponsor Geographic area for the study ResearchStudy.region
site reference Organization responsible for the Facility where study activities are conducted ResearchStudy.sponsor ResearchStudy.site
( Organization , Location , ResearchStudy )
status token draft active | in-progress active-but-not-recruiting | suspended administratively-completed | stopped approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | entered-in-error disapproved | enrolling-by-invitation | in-review | not-yet-recruiting | recruiting | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | terminated | withdrawn ResearchStudy.status
study-design token Classifications of the study design characteristics ResearchStudy.studyDesign
title string Name for this The human readable name of the research study ResearchStudy.title