This page is part of the FHIR Specification (v3.3.0: R4 Ballot 2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3

8.25 Resource ResearchStudy - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Draft

Compartments: Practitioner

A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.

8.25.1 Scope and Usage

This resource supports the HL7 mission to create and promote HL7 standards by developing Biomedical Research and Regulation standards to improve or enhance information management during clinical research and regulatory evaluation of the safety, efficacy and quality of therapeutic products and procedures worldwide.

This resource is referenced by AdverseEvent and ResearchSubject

Structure

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy	D		DomainResource	Investigation to increase healthcare-related patient-independent knowledge Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Business Identifier for study
title	Σ	0..1	string	Name for this study
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	0..*	Reference(ResearchStudy)	Part of larger study
status	?!Σ	1..1	code	active \| administratively-completed \| approved \| closed-to-accrual \| closed-to-accrual-and-intervention \| completed \| disapproved \| in-review \| temporarily-closed-to-accrual \| temporarily-closed-to-accrual-and-intervention \| withdrawn ResearchStudyStatus (Required)
primaryPurposeType	Σ	0..1	CodeableConcept	treatment \| prevention \| diagnostic \| supportive-care \| screening \| health-services-research \| basic-science \| device-feasibility ResearchStudyPrimaryPurposeType (Extensible)
phase	Σ	0..1	CodeableConcept	n-a \| early-phase-1 \| phase-1 \| phase-1-phase-2 \| phase-2 \| phase-2-phase-3 \| phase-3 \| phase-4 ResearchStudyPhase (Example)
category	Σ	0..*	CodeableConcept	Classifications for the study
focus	Σ	0..*	CodeableConcept	Drugs, devices, etc. under study
condition	Σ	0..*	Reference(Condition)	Condition being studied
contact	Σ	0..*	ContactDetail	Contact details for the study
relatedArtifact		0..*	RelatedArtifact	References and dependencies
keyword	Σ	0..*	CodeableConcept	Used to search for the study
location	Σ	0..*	CodeableConcept	Geographic region(s) for study Jurisdiction ValueSet (Extensible)
description		0..1	markdown	What this is study doing
enrollment	Σ	0..*	Reference(Group)	Inclusion & exclusion criteria
period	Σ	0..1	Period	When the study began and ended
sponsor	Σ	0..1	Reference(Organization)	Organization that initiates and is legally responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner)	Researcher who oversees multiple aspects of the study
site	Σ	0..*	Reference(Location)	Facility where study activities are conducted
reasonStopped	Σ	0..1	CodeableConcept	accrual-goal-met \| closed-due-to-toxicity \| closed-due-to-lack-of-study-progress \| temporarily-closed-per-study-design ResearchStudyReasonStopped (Example)
note		0..*	Annotation	Comments made about the study
arm		0..*	BackboneElement	Defined path through the study for a subject
name		1..1	string	Label for study arm
type		0..1	CodeableConcept	Categorization of study arm
description		0..1	string	Short explanation of study path
objective		0..*	BackboneElement	A goal for the study
name		0..1	string	Label for the objective
type		0..1	CodeableConcept	primary \| secondary \| exploratory ResearchStudyObjectiveType (Preferred)
Documentation for this format

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 -->
 <identifier><!-- 0..* Identifier Business Identifier for study --></identifier>
 <title value="[string]"/><!-- 0..1 Name for this study -->
 <protocol><!-- 0..* Reference(PlanDefinition) Steps followed in executing study --></protocol>
 <partOf><!-- 0..* Reference(ResearchStudy) Part of larger study --></partOf>
 <status value="[code]"/><!-- 1..1 active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn -->
 <primaryPurposeType><!-- 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility --></primaryPurposeType>
 <phase><!-- 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 --></phase>
 <category><!-- 0..* CodeableConcept Classifications for the study --></category>
 <focus><!-- 0..* CodeableConcept Drugs, devices, etc. under study --></focus>
 <condition><!-- 0..* Reference(Condition) Condition being studied --></condition>
 <contact><!-- 0..* ContactDetail Contact details for the study --></contact>
 <relatedArtifact><!-- 0..* RelatedArtifact References and dependencies --></relatedArtifact>
 <keyword><!-- 0..* CodeableConcept Used to search for the study --></keyword>
 <location><!-- 0..* CodeableConcept Geographic region(s) for study --></location>
 <description value="[markdown]"/><!-- 0..1 What this is study doing -->
 <enrollment><!-- 0..* Reference(Group) Inclusion & exclusion criteria --></enrollment>
 <period><!-- 0..1 Period When the study began and ended --></period>
 <sponsor><!-- 0..1 Reference(Organization) Organization that initiates and is legally responsible for the study --></sponsor>
 <principalInvestigator><!-- 0..1 Reference(Practitioner) Researcher who oversees multiple aspects of the study --></principalInvestigator>
 <site><!-- 0..* Reference(Location) Facility where study activities are conducted --></site>
 <reasonStopped><!-- 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design --></reasonStopped>
 <note><!-- 0..* Annotation Comments made about the study --></note>
 <arm>  <!-- 0..* Defined path through the study for a subject -->
  <name value="[string]"/><!-- 1..1 Label for study arm -->
  <type><!-- 0..1 CodeableConcept Categorization of study arm --></type>
  <description value="[string]"/><!-- 0..1 Short explanation of study path -->
 </arm>
 <objective>  <!-- 0..* A goal for the study -->
  <name value="[string]"/><!-- 0..1 Label for the objective -->
  <type><!-- 0..1 CodeableConcept primary | secondary | exploratory --></type>
 </objective>
</ResearchStudy>

JSON Template

{
  "resourceType" : "ResearchStudy",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business Identifier for study
  "title" : "<string>", // Name for this study
  "protocol" : [{ Reference(PlanDefinition) }], // Steps followed in executing study
  "partOf" : [{ Reference(ResearchStudy) }], // Part of larger study
  "status" : "<code>", // R!  active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  "primaryPurposeType" : { CodeableConcept }, // treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
  "phase" : { CodeableConcept }, // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  "category" : [{ CodeableConcept }], // Classifications for the study
  "focus" : [{ CodeableConcept }], // Drugs, devices, etc. under study
  "condition" : [{ Reference(Condition) }], // Condition being studied
  "contact" : [{ ContactDetail }], // Contact details for the study
  "relatedArtifact" : [{ RelatedArtifact }], // References and dependencies
  "keyword" : [{ CodeableConcept }], // Used to search for the study
  "location" : [{ CodeableConcept }], // Geographic region(s) for study
  "description" : "<markdown>", // What this is study doing
  "enrollment" : [{ Reference(Group) }], // Inclusion & exclusion criteria
  "period" : { Period }, // When the study began and ended
  "sponsor" : { Reference(Organization) }, // Organization that initiates and is legally responsible for the study
  "principalInvestigator" : { Reference(Practitioner) }, // Researcher who oversees multiple aspects of the study
  "site" : [{ Reference(Location) }], // Facility where study activities are conducted
  "reasonStopped" : { CodeableConcept }, // accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  "note" : [{ Annotation }], // Comments made about the study
  "arm" : [{ // Defined path through the study for a subject
    "name" : "<string>", // R!  Label for study arm
    "type" : { CodeableConcept }, // Categorization of study arm
    "description" : "<string>" // Short explanation of study path
  }],
  "objective" : [{ // A goal for the study
    "name" : "<string>", // Label for the objective
    "type" : { CodeableConcept } // primary | secondary | exploratory
  }]
}

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:ResearchStudy.identifier [ Identifier ], ... ; # 0..* Business Identifier for study
  fhir:ResearchStudy.title [ string ]; # 0..1 Name for this study
  fhir:ResearchStudy.protocol [ Reference(PlanDefinition) ], ... ; # 0..* Steps followed in executing study
  fhir:ResearchStudy.partOf [ Reference(ResearchStudy) ], ... ; # 0..* Part of larger study
  fhir:ResearchStudy.status [ code ]; # 1..1 active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  fhir:ResearchStudy.primaryPurposeType [ CodeableConcept ]; # 0..1 treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
  fhir:ResearchStudy.phase [ CodeableConcept ]; # 0..1 n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  fhir:ResearchStudy.category [ CodeableConcept ], ... ; # 0..* Classifications for the study
  fhir:ResearchStudy.focus [ CodeableConcept ], ... ; # 0..* Drugs, devices, etc. under study
  fhir:ResearchStudy.condition [ Reference(Condition) ], ... ; # 0..* Condition being studied
  fhir:ResearchStudy.contact [ ContactDetail ], ... ; # 0..* Contact details for the study
  fhir:ResearchStudy.relatedArtifact [ RelatedArtifact ], ... ; # 0..* References and dependencies
  fhir:ResearchStudy.keyword [ CodeableConcept ], ... ; # 0..* Used to search for the study
  fhir:ResearchStudy.location [ CodeableConcept ], ... ; # 0..* Geographic region(s) for study
  fhir:ResearchStudy.description [ markdown ]; # 0..1 What this is study doing
  fhir:ResearchStudy.enrollment [ Reference(Group) ], ... ; # 0..* Inclusion & exclusion criteria
  fhir:ResearchStudy.period [ Period ]; # 0..1 When the study began and ended
  fhir:ResearchStudy.sponsor [ Reference(Organization) ]; # 0..1 Organization that initiates and is legally responsible for the study
  fhir:ResearchStudy.principalInvestigator [ Reference(Practitioner) ]; # 0..1 Researcher who oversees multiple aspects of the study
  fhir:ResearchStudy.site [ Reference(Location) ], ... ; # 0..* Facility where study activities are conducted
  fhir:ResearchStudy.reasonStopped [ CodeableConcept ]; # 0..1 accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  fhir:ResearchStudy.note [ Annotation ], ... ; # 0..* Comments made about the study
  fhir:ResearchStudy.arm [ # 0..* Defined path through the study for a subject
    fhir:ResearchStudy.arm.name [ string ]; # 1..1 Label for study arm
    fhir:ResearchStudy.arm.type [ CodeableConcept ]; # 0..1 Categorization of study arm
    fhir:ResearchStudy.arm.description [ string ]; # 0..1 Short explanation of study path
  ], ...;
  fhir:ResearchStudy.objective [ # 0..* A goal for the study
    fhir:ResearchStudy.objective.name [ string ]; # 0..1 Label for the objective
    fhir:ResearchStudy.objective.type [ CodeableConcept ]; # 0..1 primary | secondary | exploratory
  ], ...;
]

Changes since R3

ResearchStudy

ResearchStudy.primaryPurposeType

Added Element

ResearchStudy.phase

Added Element

ResearchStudy.condition

Added Element

ResearchStudy.location

Added Element

ResearchStudy.arm.type

Added Element

ResearchStudy.objective

Added Element

ResearchStudy.objective.name

Added Element

ResearchStudy.objective.type

Added Element

ResearchStudy.jurisdiction

deleted

ResearchStudy.arm.code

deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

Structure

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy	D		DomainResource	Investigation to increase healthcare-related patient-independent knowledge Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Business Identifier for study
title	Σ	0..1	string	Name for this study
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	0..*	Reference(ResearchStudy)	Part of larger study
status	?!Σ	1..1	code	active \| administratively-completed \| approved \| closed-to-accrual \| closed-to-accrual-and-intervention \| completed \| disapproved \| in-review \| temporarily-closed-to-accrual \| temporarily-closed-to-accrual-and-intervention \| withdrawn ResearchStudyStatus (Required)
primaryPurposeType	Σ	0..1	CodeableConcept	treatment \| prevention \| diagnostic \| supportive-care \| screening \| health-services-research \| basic-science \| device-feasibility ResearchStudyPrimaryPurposeType (Extensible)
phase	Σ	0..1	CodeableConcept	n-a \| early-phase-1 \| phase-1 \| phase-1-phase-2 \| phase-2 \| phase-2-phase-3 \| phase-3 \| phase-4 ResearchStudyPhase (Example)
category	Σ	0..*	CodeableConcept	Classifications for the study
focus	Σ	0..*	CodeableConcept	Drugs, devices, etc. under study
condition	Σ	0..*	Reference(Condition)	Condition being studied
contact	Σ	0..*	ContactDetail	Contact details for the study
relatedArtifact		0..*	RelatedArtifact	References and dependencies
keyword	Σ	0..*	CodeableConcept	Used to search for the study
location	Σ	0..*	CodeableConcept	Geographic region(s) for study Jurisdiction ValueSet (Extensible)
description		0..1	markdown	What this is study doing
enrollment	Σ	0..*	Reference(Group)	Inclusion & exclusion criteria
period	Σ	0..1	Period	When the study began and ended
sponsor	Σ	0..1	Reference(Organization)	Organization that initiates and is legally responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner)	Researcher who oversees multiple aspects of the study
site	Σ	0..*	Reference(Location)	Facility where study activities are conducted
reasonStopped	Σ	0..1	CodeableConcept	accrual-goal-met \| closed-due-to-toxicity \| closed-due-to-lack-of-study-progress \| temporarily-closed-per-study-design ResearchStudyReasonStopped (Example)
note		0..*	Annotation	Comments made about the study
arm		0..*	BackboneElement	Defined path through the study for a subject
name		1..1	string	Label for study arm
type		0..1	CodeableConcept	Categorization of study arm
description		0..1	string	Short explanation of study path
objective		0..*	BackboneElement	A goal for the study
name		0..1	string	Label for the objective
type		0..1	CodeableConcept	primary \| secondary \| exploratory ResearchStudyObjectiveType (Preferred)
Documentation for this format

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 -->
 <identifier><!-- 0..* Identifier Business Identifier for study --></identifier>
 <title value="[string]"/><!-- 0..1 Name for this study -->
 <protocol><!-- 0..* Reference(PlanDefinition) Steps followed in executing study --></protocol>
 <partOf><!-- 0..* Reference(ResearchStudy) Part of larger study --></partOf>
 <status value="[code]"/><!-- 1..1 active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn -->
 <primaryPurposeType><!-- 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility --></primaryPurposeType>
 <phase><!-- 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 --></phase>
 <category><!-- 0..* CodeableConcept Classifications for the study --></category>
 <focus><!-- 0..* CodeableConcept Drugs, devices, etc. under study --></focus>
 <condition><!-- 0..* Reference(Condition) Condition being studied --></condition>
 <contact><!-- 0..* ContactDetail Contact details for the study --></contact>
 <relatedArtifact><!-- 0..* RelatedArtifact References and dependencies --></relatedArtifact>
 <keyword><!-- 0..* CodeableConcept Used to search for the study --></keyword>
 <location><!-- 0..* CodeableConcept Geographic region(s) for study --></location>
 <description value="[markdown]"/><!-- 0..1 What this is study doing -->
 <enrollment><!-- 0..* Reference(Group) Inclusion & exclusion criteria --></enrollment>
 <period><!-- 0..1 Period When the study began and ended --></period>
 <sponsor><!-- 0..1 Reference(Organization) Organization that initiates and is legally responsible for the study --></sponsor>
 <principalInvestigator><!-- 0..1 Reference(Practitioner) Researcher who oversees multiple aspects of the study --></principalInvestigator>
 <site><!-- 0..* Reference(Location) Facility where study activities are conducted --></site>
 <reasonStopped><!-- 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design --></reasonStopped>
 <note><!-- 0..* Annotation Comments made about the study --></note>
 <arm>  <!-- 0..* Defined path through the study for a subject -->
  <name value="[string]"/><!-- 1..1 Label for study arm -->
  <type><!-- 0..1 CodeableConcept Categorization of study arm --></type>
  <description value="[string]"/><!-- 0..1 Short explanation of study path -->
 </arm>
 <objective>  <!-- 0..* A goal for the study -->
  <name value="[string]"/><!-- 0..1 Label for the objective -->
  <type><!-- 0..1 CodeableConcept primary | secondary | exploratory --></type>
 </objective>
</ResearchStudy>

JSON Template

{
  "resourceType" : "ResearchStudy",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business Identifier for study
  "title" : "<string>", // Name for this study
  "protocol" : [{ Reference(PlanDefinition) }], // Steps followed in executing study
  "partOf" : [{ Reference(ResearchStudy) }], // Part of larger study
  "status" : "<code>", // R!  active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  "primaryPurposeType" : { CodeableConcept }, // treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
  "phase" : { CodeableConcept }, // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  "category" : [{ CodeableConcept }], // Classifications for the study
  "focus" : [{ CodeableConcept }], // Drugs, devices, etc. under study
  "condition" : [{ Reference(Condition) }], // Condition being studied
  "contact" : [{ ContactDetail }], // Contact details for the study
  "relatedArtifact" : [{ RelatedArtifact }], // References and dependencies
  "keyword" : [{ CodeableConcept }], // Used to search for the study
  "location" : [{ CodeableConcept }], // Geographic region(s) for study
  "description" : "<markdown>", // What this is study doing
  "enrollment" : [{ Reference(Group) }], // Inclusion & exclusion criteria
  "period" : { Period }, // When the study began and ended
  "sponsor" : { Reference(Organization) }, // Organization that initiates and is legally responsible for the study
  "principalInvestigator" : { Reference(Practitioner) }, // Researcher who oversees multiple aspects of the study
  "site" : [{ Reference(Location) }], // Facility where study activities are conducted
  "reasonStopped" : { CodeableConcept }, // accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  "note" : [{ Annotation }], // Comments made about the study
  "arm" : [{ // Defined path through the study for a subject
    "name" : "<string>", // R!  Label for study arm
    "type" : { CodeableConcept }, // Categorization of study arm
    "description" : "<string>" // Short explanation of study path
  }],
  "objective" : [{ // A goal for the study
    "name" : "<string>", // Label for the objective
    "type" : { CodeableConcept } // primary | secondary | exploratory
  }]
}

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:ResearchStudy.identifier [ Identifier ], ... ; # 0..* Business Identifier for study
  fhir:ResearchStudy.title [ string ]; # 0..1 Name for this study
  fhir:ResearchStudy.protocol [ Reference(PlanDefinition) ], ... ; # 0..* Steps followed in executing study
  fhir:ResearchStudy.partOf [ Reference(ResearchStudy) ], ... ; # 0..* Part of larger study
  fhir:ResearchStudy.status [ code ]; # 1..1 active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  fhir:ResearchStudy.primaryPurposeType [ CodeableConcept ]; # 0..1 treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
  fhir:ResearchStudy.phase [ CodeableConcept ]; # 0..1 n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  fhir:ResearchStudy.category [ CodeableConcept ], ... ; # 0..* Classifications for the study
  fhir:ResearchStudy.focus [ CodeableConcept ], ... ; # 0..* Drugs, devices, etc. under study
  fhir:ResearchStudy.condition [ Reference(Condition) ], ... ; # 0..* Condition being studied
  fhir:ResearchStudy.contact [ ContactDetail ], ... ; # 0..* Contact details for the study
  fhir:ResearchStudy.relatedArtifact [ RelatedArtifact ], ... ; # 0..* References and dependencies
  fhir:ResearchStudy.keyword [ CodeableConcept ], ... ; # 0..* Used to search for the study
  fhir:ResearchStudy.location [ CodeableConcept ], ... ; # 0..* Geographic region(s) for study
  fhir:ResearchStudy.description [ markdown ]; # 0..1 What this is study doing
  fhir:ResearchStudy.enrollment [ Reference(Group) ], ... ; # 0..* Inclusion & exclusion criteria
  fhir:ResearchStudy.period [ Period ]; # 0..1 When the study began and ended
  fhir:ResearchStudy.sponsor [ Reference(Organization) ]; # 0..1 Organization that initiates and is legally responsible for the study
  fhir:ResearchStudy.principalInvestigator [ Reference(Practitioner) ]; # 0..1 Researcher who oversees multiple aspects of the study
  fhir:ResearchStudy.site [ Reference(Location) ], ... ; # 0..* Facility where study activities are conducted
  fhir:ResearchStudy.reasonStopped [ CodeableConcept ]; # 0..1 accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  fhir:ResearchStudy.note [ Annotation ], ... ; # 0..* Comments made about the study
  fhir:ResearchStudy.arm [ # 0..* Defined path through the study for a subject
    fhir:ResearchStudy.arm.name [ string ]; # 1..1 Label for study arm
    fhir:ResearchStudy.arm.type [ CodeableConcept ]; # 0..1 Categorization of study arm
    fhir:ResearchStudy.arm.description [ string ]; # 0..1 Short explanation of study path
  ], ...;
  fhir:ResearchStudy.objective [ # 0..* A goal for the study
    fhir:ResearchStudy.objective.name [ string ]; # 0..1 Label for the objective
    fhir:ResearchStudy.objective.type [ CodeableConcept ]; # 0..1 primary | secondary | exploratory
  ], ...;
]

Changes since DSTU2

ResearchStudy

ResearchStudy.primaryPurposeType

Added Element

ResearchStudy.phase

Added Element

ResearchStudy.condition

Added Element

ResearchStudy.location

Added Element

ResearchStudy.arm.type

Added Element

ResearchStudy.objective

Added Element

ResearchStudy.objective.name

Added Element

ResearchStudy.objective.type

Added Element

ResearchStudy.jurisdiction

deleted

ResearchStudy.arm.code

deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

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

8.25.2.1 Terminology Bindings

Path	Definition	Type	Reference
ResearchStudy.status	Codes that convey the current status of the research study	Required	ResearchStudyStatus
ResearchStudy.primaryPurposeType	Codes for the main intent of the study	Extensible	ResearchStudyPrimaryPurposeType
ResearchStudy.phase	Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.	Example	ResearchStudyPhase
ResearchStudy.category	Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.	Unknown	No details provided yet
ResearchStudy.focus	Codes for medications, devices and other interventions	Unknown	No details provided yet
ResearchStudy.keyword	Words associated with the study that may be useful in discovery	Unknown	No details provided yet
ResearchStudy.location	Countries and regions within which this artifact is targeted for use	Extensible	Jurisdiction ValueSet
ResearchStudy.reasonStopped	Codes for why the study ended prematurely	Example	ResearchStudyReasonStopped
ResearchStudy.objective.type	Codes for the kind of study objective	Preferred	ResearchStudyObjectiveType

Path

Definition

Type

Reference

ResearchStudy.status

Codes that convey the current status of the research study

Required

ResearchStudyStatus

ResearchStudy.primaryPurposeType

Codes for the main intent of the study

Extensible

ResearchStudyPrimaryPurposeType

ResearchStudy.phase

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

Example

ResearchStudyPhase

ResearchStudy.category

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

Unknown

No details provided yet

ResearchStudy.focus

Codes for medications, devices and other interventions

Unknown

No details provided yet

ResearchStudy.keyword

Words associated with the study that may be useful in discovery

Unknown

No details provided yet

ResearchStudy.location

Countries and regions within which this artifact is targeted for use

Extensible

Jurisdiction ValueSet

ResearchStudy.reasonStopped

Codes for why the study ended prematurely

Example

ResearchStudyReasonStopped

ResearchStudy.objective.type

Codes for the kind of study objective

Preferred

ResearchStudyObjectiveType

8.25.3 ResearchStudy State Machine

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

Diagram showing typical state machine for the ResearchStudy resource

8.25.4 Search Parameters

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

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