This page is part of the FHIR Specification (v4.3.0: R4B - STU). 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
Biomedical Research and Regulation Work Group | Maturity Level: 1 | Trial Use | Security Category: Business | Compartments: Practitioner |
A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
This resource is an definition resource from a FHIR workflow perspective - see Workflow.
A research study is a scientific way to improve or develop new methods of health care. Studies are designed to answer specific questions on how to prevent, diagnose, or treat diseases and disorders. The ResearchStudy resource describes essential information about the study, including the purpose, objective, sponsor, investigator, therapy, condition being studied, schedule of activities, and other key items.
Uses for the ResearchStudy resource include:
This resource is referenced by UsageContext, AdverseEvent, MedicinalProductDefinition, RegulatedAuthorization, itself and ResearchSubject.
This resource does not implement any patterns.
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 | |
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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn ResearchStudyStatus (Required) |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 ResearchStudyCategory (Example) |
focus | Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study ResearchStudyFocus (Example) |
condition | Σ | 0..* | CodeableConcept | Condition being studied Condition/Problem/Diagnosis Codes (Example) |
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 ResearchStudyKeyword (Example) |
location | Σ | 0..* | CodeableConcept | Geographic region(s) for study Jurisdiction (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 | PractitionerRole) | 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..* CodeableConcept 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|PractitionerRole) 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" : [{ CodeableConcept }], // 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|PractitionerRole) }, // 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 [ CodeableConcept ], ... ; # 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|PractitionerRole) ]; # 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 R4
ResearchStudy |
|
See the Full Difference for further information
This analysis is available as XML or JSON.
Conversions between R3 and R4
See R3 <--> R4 Conversion Maps (status = 1 test that all execute ok. All tests pass round-trip testing and all r3 resources are valid.)
Structure
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
ResearchStudy | TU | 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 ResearchStudyCategory (Example) |
focus | Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study ResearchStudyFocus (Example) |
condition | Σ | 0..* | CodeableConcept | Condition being studied Condition/Problem/Diagnosis Codes (Example) |
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 ResearchStudyKeyword (Example) |
location | Σ | 0..* | CodeableConcept | Geographic region(s) for study Jurisdiction (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 | PractitionerRole) | 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 |
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..* CodeableConcept 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|PractitionerRole) 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" : [{ CodeableConcept }], // 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|PractitionerRole) }, // 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 [ CodeableConcept ], ... ; # 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|PractitionerRole) ]; # 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 Release 4
ResearchStudy |
|
See the Full Difference for further information
This analysis is available as XML or JSON.
Conversions between R3 and R4
See R3 <--> R4 Conversion Maps (status = 1 test that all execute ok. All tests pass round-trip testing and all r3 resources are valid.)
See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis
Path | Definition | Type | Reference |
---|---|---|---|
ResearchStudy.status | Required | ResearchStudyStatus | |
ResearchStudy.primaryPurposeType | Extensible | ResearchStudyPrimaryPurposeType | |
ResearchStudy.phase | Example | ResearchStudyPhase | |
ResearchStudy.category | Example | ?? | |
ResearchStudy.focus | Example | ?? | |
ResearchStudy.condition | Example | Condition/Problem/DiagnosisCodes | |
ResearchStudy.keyword | Example | ?? | |
ResearchStudy.location | Extensible | Jurisdiction ValueSet | |
ResearchStudy.reasonStopped | Example | ResearchStudyReasonStopped | |
ResearchStudy.objective.type | Preferred | ResearchStudyObjectiveType |
The following diagram reflects the "typical" state machine for ResearchStudy.
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, PractitionerRole) | |
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 |