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8.25 Resource ResearchStudy - Content

Biomedical Research and Regulation icon

Work Group

Maturity Level: 0

Security Category: Business

Compartments: No defined compartments

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

8.25.1 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 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

8.25.1.1 Extensions

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

Extension: SiteRecruitment

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

Extension: StudyRegistration

Used to separate study registration activities from study progress status.

8.25.2 References to this Resource

Resource References: AdverseEvent, MedicinalProductDefinition, RegulatedAuthorization, itself, ResearchSubject and UsageContext
Extension References: Consent Research Study Context and Research study

8.25.3 Resource Content

Structure
UML
XML
JSON
Turtle
R4 Diff
All

Structure

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)	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
targetNumber		0..1	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(Group)	Inclusion and exclusion criteria for the comparison group
observedGroup		0..1	Reference(Group)	Group of participants who were enrolled in the comparison group
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 measure
type		0..1	CodeableConcept	primary \| secondary \| exploratory Binding: Research Study Objective Type (Preferred)
description		0..1	markdown	Description of the outcome measure
endpoint		1..1	Reference(EvidenceVariable)	Definition of the outcome measure
population		0..1	Reference(Group)	Population for this estimand
intervention		0..1	Reference(Group)	Comparison group of interest
comparator		0..1	Reference(Group)	Comparison group for comparison
summaryMeasure		0..1	CodeableConcept	Statistical measure for treatment effect estimate Binding: Statistic Type (Example)
eventHandling		0..*	BackboneElement	Handling of intercurrent event
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
description		0..1	markdown	Text summary of event handling
result	Σ	0..*	Reference(Citation \| Composition \| DiagnosticReport)	Link to results generated during the study
Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

XML Template

<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(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 -->
  <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>
 </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 -->
  <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 --></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 --></summaryMeasure>
   <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(Citation|Composition|DiagnosticReport) Link to results generated during the study --></result>
</ResearchStudy>

JSON Template

{
  "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(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
    "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
  }],
  "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 measure
      "type" : { CodeableConcept }, // primary | secondary | exploratory
      "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
      "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(Citation|Composition|DiagnosticReport) }] // Link to results generated during the study
}

Turtle Template

@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(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: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: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: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(Citation|Composition|DiagnosticReport) ] ... ) ; # 0..* Link to results generated during the study
]

Changes from both R4 and R4B

ResearchStudy.url

Added Element

ResearchStudy.version

Added Element

ResearchStudy.name

Added Element

ResearchStudy.label

Added Element

ResearchStudy.label.type

Added Element

ResearchStudy.label.value

Added Element

ResearchStudy.date

Added Element

ResearchStudy.status

Change value set from http://hl7.org/fhir/ValueSet/research-study-status|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.comparisonGroup

Added Element

ResearchStudy.comparisonGroup.targetNumber

Added Element

ResearchStudy.comparisonGroup.actualNumber

Added Element

ResearchStudy.comparisonGroup.eligibility

Added Element

ResearchStudy.comparisonGroup.observedGroup

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.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.location

Deleted

ResearchStudy.enrollment

Deleted

ResearchStudy.sponsor

Deleted

ResearchStudy.principalInvestigator

Deleted

ResearchStudy.reasonStopped

Deleted

ResearchStudy.arm

Deleted

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

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)	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
targetNumber		0..1	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(Group)	Inclusion and exclusion criteria for the comparison group
observedGroup		0..1	Reference(Group)	Group of participants who were enrolled in the comparison group
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 measure
type		0..1	CodeableConcept	primary \| secondary \| exploratory Binding: Research Study Objective Type (Preferred)
description		0..1	markdown	Description of the outcome measure
endpoint		1..1	Reference(EvidenceVariable)	Definition of the outcome measure
population		0..1	Reference(Group)	Population for this estimand
intervention		0..1	Reference(Group)	Comparison group of interest
comparator		0..1	Reference(Group)	Comparison group for comparison
summaryMeasure		0..1	CodeableConcept	Statistical measure for treatment effect estimate Binding: Statistic Type (Example)
eventHandling		0..*	BackboneElement	Handling of intercurrent event
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
description		0..1	markdown	Text summary of event handling
result	Σ	0..*	Reference(Citation \| Composition \| DiagnosticReport)	Link to results generated during the study
Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

XML Template

<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(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 -->
  <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>
 </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 -->
  <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 --></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 --></summaryMeasure>
   <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(Citation|Composition|DiagnosticReport) Link to results generated during the study --></result>
</ResearchStudy>

JSON Template

{
  "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(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
    "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
  }],
  "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 measure
      "type" : { CodeableConcept }, // primary | secondary | exploratory
      "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
      "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(Citation|Composition|DiagnosticReport) }] // Link to results generated during the study
}

Turtle Template

@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(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: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: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: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(Citation|Composition|DiagnosticReport) ] ... ) ; # 0..* Link to results generated during the study
]

Changes from both R4 and R4B

ResearchStudy.url

Added Element

ResearchStudy.version

Added Element

ResearchStudy.name

Added Element

ResearchStudy.label

Added Element

ResearchStudy.label.type

Added Element

ResearchStudy.label.value

Added Element

ResearchStudy.date

Added Element

ResearchStudy.status

Change value set from http://hl7.org/fhir/ValueSet/research-study-status|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.comparisonGroup

Added Element

ResearchStudy.comparisonGroup.targetNumber

Added Element

ResearchStudy.comparisonGroup.actualNumber

Added Element

ResearchStudy.comparisonGroup.eligibility

Added Element

ResearchStudy.comparisonGroup.observedGroup

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.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.location

Deleted

ResearchStudy.enrollment

Deleted

ResearchStudy.sponsor

Deleted

ResearchStudy.principalInvestigator

Deleted

ResearchStudy.reasonStopped

Deleted

ResearchStudy.arm

Deleted

See the Full Difference for further information

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

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

8.25.3.1 Terminology Bindings

Path

ValueSet

Type

Documentation

ResearchStudy.label.type

Used to express the reason and specific aspect for the variant title, such as language and specific language.

ResearchStudy.status

PublicationStatus

The lifecycle status of an artifact.

ResearchStudy.primaryPurposeType

ResearchStudyPrimaryPurposeType (a valid code from ResearchStudy Primary Purpose Type Code System)

Codes for the main intent of the study.

ResearchStudy.phase

ResearchStudyPhase (a valid code from ResearchStudy Phase Code System)

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

This is a set of terms for study design characteristics.

ResearchStudy.focus

ResearchStudyFocusType (a valid code from ResearchStudy Focus Type Code System)

Codes for the main intent of the study.

ResearchStudy.condition

ConditionProblemDiagnosisCodes

Example value set for Condition/Problem/Diagnosis codes.

ResearchStudy.keyword

ResearchStudy.region

JurisdictionValueSet

This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be 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)

Codes that convey the type of label that is provided.

ResearchStudy.associatedParty.role

ResearchStudyPartyRole

This is a ResearchStudy's party role.

ResearchStudy.associatedParty.classifier

ResearchStudyPartyOrgType (a valid code from ResearchStudy Party Organization Type Code System)

This is a ResearchStudy's party organization type.

ResearchStudy.progressStatus.state

ResearchStudyStatus

Codes that convey the current status of the research study.

ResearchStudy.whyStopped

ResearchStudyReasonStopped (a valid code from ResearchStudy Reason Stopped Code System)

Codes for why the study ended prematurely.

ResearchStudy.objective.type

ResearchStudyObjectiveType (a valid code from ResearchStudy Objective Type Code System)

Codes for the kind of study objective.

ResearchStudy.objective.outcomeMeasure.type

ResearchStudyObjectiveType (a valid code from ResearchStudy Objective Type Code System)

Codes for the kind of study objective.

ResearchStudy.objective.outcomeMeasure.summaryMeasure

StatisticType (a valid code from StatisticStatisticType icon

)

The type of a statistic, e.g. relative risk or mean

8.25.4 ResearchStudy State Machine

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

Diagram showing typical state machine for the ResearchStudy resource

8.25.5 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	token	Classification for the study	ResearchStudy.classifier
condition	token	Condition being studied	ResearchStudy.condition
date	date	When the study began and ended	ResearchStudy.period
description	string	Detailed narrative of the study	ResearchStudy.description
eligibility	reference	Inclusion and exclusion criteria	ResearchStudy.recruitment.eligibility (Group)
focus-code	token	Drugs, devices, etc. under study, as a code	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
keyword	token	Used to search for the study	ResearchStudy.keyword
name	string	Name for this study	ResearchStudy.name
objective-description	string	Free text description of the objective of the study	ResearchStudy.objective.description
objective-type	token	The kind of study objective	ResearchStudy.objective.type
part-of	reference	Part of larger study	ResearchStudy.partOf (ResearchStudy)
phase	token	The stage in the progression of a study	ResearchStudy.phase
progress-status-state-actual	composite	Status of study by state and actual	On ResearchStudy.progressStatus: state: state actual: actual
progress-status-state-period	composite	Status of study by state and period	On ResearchStudy.progressStatus: state: state period: period
progress-status-state-period-actual	composite	Status of study by state, period and actual	On ResearchStudy.progressStatus: state: state period: period actual: actual
protocol	reference	Steps followed in executing study	ResearchStudy.protocol (PlanDefinition)
recruitment-actual	number	Actual number of participants enrolled in study across all groups	ResearchStudy.recruitment.actualNumber
recruitment-target	number	Target number of participants enrolled in study across all groups	ResearchStudy.recruitment.targetNumber
region	token	Geographic area for the study	ResearchStudy.region
site	reference	Facility where study activities are conducted	ResearchStudy.site (Organization, Location, ResearchStudy)
status	token	active \| active-but-not-recruiting \| administratively-completed \| approved \| closed-to-accrual \| closed-to-accrual-and-intervention \| completed \| 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	The human readable name of the research study	ResearchStudy.title