8.25 Resource ResearchStudy - Content

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy	TU		DomainResource	Investigation to increase healthcare-related patient-independent knowledge Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
url		0..1	uri	Canonical identifier for this study resource
identifier	Σ	0..*	Identifier	Business Identifier for study
version		0..1	string	The business version for the study record
name		0..1	string	Name for this study (computer friendly)
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 (Extensible)
value		0..1	string	The name
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	0..*	Reference(ResearchStudy)	Part of larger study
relatedArtifact		0..*	RelatedArtifact	References, URLs, and attachments
date		0..1	dateTime	Date the resource last changed
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (Required)
primaryPurposeType	Σ	0..1	CodeableConcept	treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: Research Study Primary Purpose Type (Preferred)
phase	Σ	0..1	CodeableConcept	n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: Research Study Phase (Example)
studyDesign	Σ	0..*	CodeableConcept	Classifications of the study design characteristics Binding: Study Design (Preferred)
focus		0..*	CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable)	Drugs, devices, etc. under study Binding: Research Study Focus Type (Example)
condition	Σ	0..*	CodeableConcept	Condition being studied Binding: Condition/Problem/Diagnosis Codes (Example)
keyword	Σ	0..*	CodeableConcept	Used to search for the study Binding: ResearchStudyKeyword (Example)
region	Σ	0..*	CodeableConcept	Geographic area for the study Binding: Jurisdiction ValueSet (Extensible)
descriptionSummary		0..1	markdown	Brief text explaining the study
description		0..1	markdown	Detailed narrative of the study
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
role		1..1	CodeableConcept	sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair Binding: Research Study Party Role (Extensible)
period		0..*	Period	When active in the role
classifier		0..*	CodeableConcept	nih | fda | government | nonprofit | academic | industry Binding: Research Study Party Organization Type (Example)
party		0..1	Reference(Practitioner | PractitionerRole | Organization)	Individual or organization associated with study (use practitionerRole to specify their organisation)
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)
actual		0..1	boolean	Actual if true else anticipated
period		0..1	Period	Date range
whyStopped	Σ	0..1	CodeableConcept	accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: Research Study Reason Stopped (Example)
recruitment	Σ	0..1	BackboneElement	Target or actual group of participants enrolled in study
targetNumber		0..1	unsignedInt	Estimated total number of participants to be enrolled
actualNumber		0..1	unsignedInt	Actual total number of participants enrolled in study
eligibility		0..1	Reference(Group | EvidenceVariable)	Inclusion and exclusion criteria
actualGroup	Σ	0..1	Reference(Group)	Group of participants who were enrolled in study
comparisonGroup		0..*	BackboneElement	Defined path through the study for a subject
linkId		0..1	id	Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
name		1..1	string	Label for study comparisonGroup
type		0..1	CodeableConcept	Categorization of study comparisonGroup Binding: Research Study Arm Type (Extensible)
description		0..1	markdown	Short explanation of study path
intendedExposure		0..*	Reference(EvidenceVariable)	Interventions or exposures in this comparisonGroup or cohort
observedGroup		0..1	Reference(Group)	Group of participants who were enrolled in study comparisonGroup
objective		0..*	BackboneElement	A goal for the study
name		0..1	string	Label for the objective
type		0..1	CodeableConcept	primary | secondary | exploratory Binding: Research Study Objective Type (Preferred)
description		0..1	markdown	Description of the objective
outcomeMeasure		0..*	BackboneElement	A variable measured during the study
name		0..1	string	Label for the outcome
type		0..*	CodeableConcept	primary | secondary | exploratory Binding: Research Study Objective Type (Preferred)
description		0..1	markdown	Description of the outcome
reference		0..1	Reference(EvidenceVariable)	Structured outcome definition
result	Σ	0..*	Reference(Citation | Composition | DiagnosticReport)	Link to results generated during the study
Documentation for this format

See the Extensions for this resource

<ResearchStudy xmlns="http://hl7.org/fhir"> 
 <!-- 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 --></type>
  <value value="[string]"/><!-- 0..1 The name -->
 </label>
 <protocol><!-- 0..* Reference(PlanDefinition) Steps followed in executing study --></protocol>
 <partOf><!-- 0..* Reference(ResearchStudy) Part of larger study --></partOf>
 <relatedArtifact><!-- 0..* RelatedArtifact References, URLs, and attachments --></relatedArtifact>
 <date value="[dateTime]"/><!-- 0..1 Date the resource last changed -->
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <primaryPurposeType><!-- 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility --></primaryPurposeType>
 <phase><!-- 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 --></phase>
 <studyDesign><!-- 0..* CodeableConcept Classifications of the study design characteristics --></studyDesign>
 <focus><!-- 0..* CodeableReference(EvidenceVariable|Medication|
   MedicinalProductDefinition|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 --></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>
 <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-director | study-chair --></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 --></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(EvidenceVariable|Group) Inclusion and exclusion criteria --></eligibility>
  <actualGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study --></actualGroup>
 </recruitment>
 <comparisonGroup>  <!-- 0..* Defined path through the study for a subject -->
  <linkId value="[id]"/><!-- 0..1 Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily -->
  <name value="[string]"/><!-- 1..1 Label for study comparisonGroup -->
  <type><!-- 0..1 CodeableConcept Categorization of study comparisonGroup --></type>
  <description value="[markdown]"/><!-- 0..1 Short explanation of study path -->
  <intendedExposure><!-- 0..* Reference(EvidenceVariable) Interventions or exposures in this comparisonGroup or cohort --></intendedExposure>
  <observedGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study comparisonGroup --></observedGroup>
 </comparisonGroup>
 <objective>  <!-- 0..* A goal for the study -->
  <name value="[string]"/><!-- 0..1 Label for the objective -->
  <type><!-- 0..1 CodeableConcept primary | secondary | exploratory --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the objective -->
 </objective>
 <outcomeMeasure>  <!-- 0..* A variable measured during the study -->
  <name value="[string]"/><!-- 0..1 Label for the outcome -->
  <type><!-- 0..* CodeableConcept primary | secondary | exploratory --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the outcome -->
  <reference><!-- 0..1 Reference(EvidenceVariable) Structured outcome definition --></reference>
 </outcomeMeasure>
 <result><!-- 0..* Reference(Citation|Composition|DiagnosticReport) Link to results generated during the study --></result>
</ResearchStudy>

{
  "resourceType" : "ResearchStudy",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "url" : "<uri>", // Canonical identifier for this study resource
  "identifier" : [{ Identifier }], // Business Identifier for study
  "version" : "<string>", // 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
    "value" : "<string>" // The name
  }],
  "protocol" : [{ Reference(PlanDefinition) }], // Steps followed in executing study
  "partOf" : [{ Reference(ResearchStudy) }], // Part of larger study
  "relatedArtifact" : [{ RelatedArtifact }], // References, URLs, and attachments
  "date" : "<dateTime>", // Date the resource last changed
  "status" : "<code>", // R!  draft | active | retired | unknown
  "primaryPurposeType" : { CodeableConcept }, // treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
  "phase" : { CodeableConcept }, // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  "studyDesign" : [{ CodeableConcept }], // Classifications of the study design characteristics
  "focus" : [{ CodeableReference(EvidenceVariable|Medication|
   MedicinalProductDefinition|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
  "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-director | study-chair
    "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
  "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(EvidenceVariable|Group) }, // Inclusion and exclusion criteria
    "actualGroup" : { Reference(Group) } // Group of participants who were enrolled in study
  },
  "comparisonGroup" : [{ // Defined path through the study for a subject
    "linkId" : "<id>", // Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
    "name" : "<string>", // R!  Label for study comparisonGroup
    "type" : { CodeableConcept }, // Categorization of study comparisonGroup
    "description" : "<markdown>", // Short explanation of study path
    "intendedExposure" : [{ Reference(EvidenceVariable) }], // Interventions or exposures in this comparisonGroup or cohort
    "observedGroup" : { Reference(Group) } // Group of participants who were enrolled in study comparisonGroup
  }],
  "objective" : [{ // A goal for the study
    "name" : "<string>", // Label for the objective
    "type" : { CodeableConcept }, // primary | secondary | exploratory
    "description" : "<markdown>" // Description of the objective
  }],
  "outcomeMeasure" : [{ // A variable measured during the study
    "name" : "<string>", // Label for the outcome
    "type" : [{ CodeableConcept }], // primary | secondary | exploratory
    "description" : "<markdown>", // Description of the outcome
    "reference" : { Reference(EvidenceVariable) } // Structured outcome definition
  }],
  "result" : [{ Reference(Citation|Composition|DiagnosticReport) }] // Link to results generated during the study
}

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


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

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir: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:protocol  ( [ Reference(PlanDefinition) ] ... ) ; # 0..* Steps followed in executing study
  fhir:partOf  ( [ Reference(ResearchStudy) ] ... ) ; # 0..* Part of larger study
  fhir:relatedArtifact  ( [ RelatedArtifact ] ... ) ; # 0..* References, URLs, and attachments
  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 n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  fhir:studyDesign  ( [ CodeableConcept ] ... ) ; # 0..* Classifications of the study design characteristics
  fhir:focus  ( [ CodeableReference(EvidenceVariable|Medication|MedicinalProductDefinition|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-director | study-chair
    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(EvidenceVariable|Group) ] ; # 0..1 Inclusion and exclusion criteria
    fhir:actualGroup [ Reference(Group) ] ; # 0..1 Group of participants who were enrolled in study
  ] ;
  fhir:comparisonGroup ( [ # 0..* Defined path through the study for a subject
    fhir:linkId [ id ] ; # 0..1 Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
    fhir:name [ string ] ; # 1..1 Label for study comparisonGroup
    fhir:type [ CodeableConcept ] ; # 0..1 Categorization of study comparisonGroup
    fhir:description [ markdown ] ; # 0..1 Short explanation of study path
    fhir:intendedExposure  ( [ Reference(EvidenceVariable) ] ... ) ; # 0..* Interventions or exposures in this comparisonGroup or cohort
    fhir:observedGroup [ Reference(Group) ] ; # 0..1 Group of participants who were enrolled in study comparisonGroup
  ] ... ) ;
  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
    fhir:type  ( [ CodeableConcept ] ... ) ; # 0..* primary | secondary | exploratory
    fhir:description [ markdown ] ; # 0..1 Description of the outcome
    fhir:reference [ Reference(EvidenceVariable) ] ; # 0..1 Structured outcome definition
  ] ... ) ;
  fhir:result  ( [ Reference(Citation|Composition|DiagnosticReport) ] ... ) ; # 0..* Link to results generated during the study
]

Changes from both R4 and R4B

See the Full Difference for further information

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

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy	TU		DomainResource	Investigation to increase healthcare-related patient-independent knowledge Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
url		0..1	uri	Canonical identifier for this study resource
identifier	Σ	0..*	Identifier	Business Identifier for study
version		0..1	string	The business version for the study record
name		0..1	string	Name for this study (computer friendly)
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 (Extensible)
value		0..1	string	The name
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	0..*	Reference(ResearchStudy)	Part of larger study
relatedArtifact		0..*	RelatedArtifact	References, URLs, and attachments
date		0..1	dateTime	Date the resource last changed
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (Required)
primaryPurposeType	Σ	0..1	CodeableConcept	treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: Research Study Primary Purpose Type (Preferred)
phase	Σ	0..1	CodeableConcept	n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: Research Study Phase (Example)
studyDesign	Σ	0..*	CodeableConcept	Classifications of the study design characteristics Binding: Study Design (Preferred)
focus		0..*	CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable)	Drugs, devices, etc. under study Binding: Research Study Focus Type (Example)
condition	Σ	0..*	CodeableConcept	Condition being studied Binding: Condition/Problem/Diagnosis Codes (Example)
keyword	Σ	0..*	CodeableConcept	Used to search for the study Binding: ResearchStudyKeyword (Example)
region	Σ	0..*	CodeableConcept	Geographic area for the study Binding: Jurisdiction ValueSet (Extensible)
descriptionSummary		0..1	markdown	Brief text explaining the study
description		0..1	markdown	Detailed narrative of the study
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
role		1..1	CodeableConcept	sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair Binding: Research Study Party Role (Extensible)
period		0..*	Period	When active in the role
classifier		0..*	CodeableConcept	nih | fda | government | nonprofit | academic | industry Binding: Research Study Party Organization Type (Example)
party		0..1	Reference(Practitioner | PractitionerRole | Organization)	Individual or organization associated with study (use practitionerRole to specify their organisation)
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)
actual		0..1	boolean	Actual if true else anticipated
period		0..1	Period	Date range
whyStopped	Σ	0..1	CodeableConcept	accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: Research Study Reason Stopped (Example)
recruitment	Σ	0..1	BackboneElement	Target or actual group of participants enrolled in study
targetNumber		0..1	unsignedInt	Estimated total number of participants to be enrolled
actualNumber		0..1	unsignedInt	Actual total number of participants enrolled in study
eligibility		0..1	Reference(Group | EvidenceVariable)	Inclusion and exclusion criteria
actualGroup	Σ	0..1	Reference(Group)	Group of participants who were enrolled in study
comparisonGroup		0..*	BackboneElement	Defined path through the study for a subject
linkId		0..1	id	Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
name		1..1	string	Label for study comparisonGroup
type		0..1	CodeableConcept	Categorization of study comparisonGroup Binding: Research Study Arm Type (Extensible)
description		0..1	markdown	Short explanation of study path
intendedExposure		0..*	Reference(EvidenceVariable)	Interventions or exposures in this comparisonGroup or cohort
observedGroup		0..1	Reference(Group)	Group of participants who were enrolled in study comparisonGroup
objective		0..*	BackboneElement	A goal for the study
name		0..1	string	Label for the objective
type		0..1	CodeableConcept	primary | secondary | exploratory Binding: Research Study Objective Type (Preferred)
description		0..1	markdown	Description of the objective
outcomeMeasure		0..*	BackboneElement	A variable measured during the study
name		0..1	string	Label for the outcome
type		0..*	CodeableConcept	primary | secondary | exploratory Binding: Research Study Objective Type (Preferred)
description		0..1	markdown	Description of the outcome
reference		0..1	Reference(EvidenceVariable)	Structured outcome definition
result	Σ	0..*	Reference(Citation | Composition | DiagnosticReport)	Link to results generated during the study
Documentation for this format

See the Extensions for this resource

<ResearchStudy xmlns="http://hl7.org/fhir"> 
 <!-- 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 --></type>
  <value value="[string]"/><!-- 0..1 The name -->
 </label>
 <protocol><!-- 0..* Reference(PlanDefinition) Steps followed in executing study --></protocol>
 <partOf><!-- 0..* Reference(ResearchStudy) Part of larger study --></partOf>
 <relatedArtifact><!-- 0..* RelatedArtifact References, URLs, and attachments --></relatedArtifact>
 <date value="[dateTime]"/><!-- 0..1 Date the resource last changed -->
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <primaryPurposeType><!-- 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility --></primaryPurposeType>
 <phase><!-- 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 --></phase>
 <studyDesign><!-- 0..* CodeableConcept Classifications of the study design characteristics --></studyDesign>
 <focus><!-- 0..* CodeableReference(EvidenceVariable|Medication|
   MedicinalProductDefinition|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 --></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>
 <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-director | study-chair --></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 --></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(EvidenceVariable|Group) Inclusion and exclusion criteria --></eligibility>
  <actualGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study --></actualGroup>
 </recruitment>
 <comparisonGroup>  <!-- 0..* Defined path through the study for a subject -->
  <linkId value="[id]"/><!-- 0..1 Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily -->
  <name value="[string]"/><!-- 1..1 Label for study comparisonGroup -->
  <type><!-- 0..1 CodeableConcept Categorization of study comparisonGroup --></type>
  <description value="[markdown]"/><!-- 0..1 Short explanation of study path -->
  <intendedExposure><!-- 0..* Reference(EvidenceVariable) Interventions or exposures in this comparisonGroup or cohort --></intendedExposure>
  <observedGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study comparisonGroup --></observedGroup>
 </comparisonGroup>
 <objective>  <!-- 0..* A goal for the study -->
  <name value="[string]"/><!-- 0..1 Label for the objective -->
  <type><!-- 0..1 CodeableConcept primary | secondary | exploratory --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the objective -->
 </objective>
 <outcomeMeasure>  <!-- 0..* A variable measured during the study -->
  <name value="[string]"/><!-- 0..1 Label for the outcome -->
  <type><!-- 0..* CodeableConcept primary | secondary | exploratory --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the outcome -->
  <reference><!-- 0..1 Reference(EvidenceVariable) Structured outcome definition --></reference>
 </outcomeMeasure>
 <result><!-- 0..* Reference(Citation|Composition|DiagnosticReport) Link to results generated during the study --></result>
</ResearchStudy>

{
  "resourceType" : "ResearchStudy",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "url" : "<uri>", // Canonical identifier for this study resource
  "identifier" : [{ Identifier }], // Business Identifier for study
  "version" : "<string>", // 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
    "value" : "<string>" // The name
  }],
  "protocol" : [{ Reference(PlanDefinition) }], // Steps followed in executing study
  "partOf" : [{ Reference(ResearchStudy) }], // Part of larger study
  "relatedArtifact" : [{ RelatedArtifact }], // References, URLs, and attachments
  "date" : "<dateTime>", // Date the resource last changed
  "status" : "<code>", // R!  draft | active | retired | unknown
  "primaryPurposeType" : { CodeableConcept }, // treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
  "phase" : { CodeableConcept }, // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  "studyDesign" : [{ CodeableConcept }], // Classifications of the study design characteristics
  "focus" : [{ CodeableReference(EvidenceVariable|Medication|
   MedicinalProductDefinition|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
  "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-director | study-chair
    "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
  "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(EvidenceVariable|Group) }, // Inclusion and exclusion criteria
    "actualGroup" : { Reference(Group) } // Group of participants who were enrolled in study
  },
  "comparisonGroup" : [{ // Defined path through the study for a subject
    "linkId" : "<id>", // Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
    "name" : "<string>", // R!  Label for study comparisonGroup
    "type" : { CodeableConcept }, // Categorization of study comparisonGroup
    "description" : "<markdown>", // Short explanation of study path
    "intendedExposure" : [{ Reference(EvidenceVariable) }], // Interventions or exposures in this comparisonGroup or cohort
    "observedGroup" : { Reference(Group) } // Group of participants who were enrolled in study comparisonGroup
  }],
  "objective" : [{ // A goal for the study
    "name" : "<string>", // Label for the objective
    "type" : { CodeableConcept }, // primary | secondary | exploratory
    "description" : "<markdown>" // Description of the objective
  }],
  "outcomeMeasure" : [{ // A variable measured during the study
    "name" : "<string>", // Label for the outcome
    "type" : [{ CodeableConcept }], // primary | secondary | exploratory
    "description" : "<markdown>", // Description of the outcome
    "reference" : { Reference(EvidenceVariable) } // Structured outcome definition
  }],
  "result" : [{ Reference(Citation|Composition|DiagnosticReport) }] // Link to results generated during the study
}

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


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

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir: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:protocol  ( [ Reference(PlanDefinition) ] ... ) ; # 0..* Steps followed in executing study
  fhir:partOf  ( [ Reference(ResearchStudy) ] ... ) ; # 0..* Part of larger study
  fhir:relatedArtifact  ( [ RelatedArtifact ] ... ) ; # 0..* References, URLs, and attachments
  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 n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  fhir:studyDesign  ( [ CodeableConcept ] ... ) ; # 0..* Classifications of the study design characteristics
  fhir:focus  ( [ CodeableReference(EvidenceVariable|Medication|MedicinalProductDefinition|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-director | study-chair
    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(EvidenceVariable|Group) ] ; # 0..1 Inclusion and exclusion criteria
    fhir:actualGroup [ Reference(Group) ] ; # 0..1 Group of participants who were enrolled in study
  ] ;
  fhir:comparisonGroup ( [ # 0..* Defined path through the study for a subject
    fhir:linkId [ id ] ; # 0..1 Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
    fhir:name [ string ] ; # 1..1 Label for study comparisonGroup
    fhir:type [ CodeableConcept ] ; # 0..1 Categorization of study comparisonGroup
    fhir:description [ markdown ] ; # 0..1 Short explanation of study path
    fhir:intendedExposure  ( [ Reference(EvidenceVariable) ] ... ) ; # 0..* Interventions or exposures in this comparisonGroup or cohort
    fhir:observedGroup [ Reference(Group) ] ; # 0..1 Group of participants who were enrolled in study comparisonGroup
  ] ... ) ;
  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
    fhir:type  ( [ CodeableConcept ] ... ) ; # 0..* primary | secondary | exploratory
    fhir:description [ markdown ] ; # 0..1 Description of the outcome
    fhir:reference [ Reference(EvidenceVariable) ] ; # 0..1 Structured outcome definition
  ] ... ) ;
  fhir:result  ( [ Reference(Citation|Composition|DiagnosticReport) ] ... ) ; # 0..* Link to results generated during the study
]

Changes from both R4 and R4B

See the Full Difference for further information

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