Release 5
AdministrationThis page is part of the FHIR Specification (v5.0.0: R5 - STU). This is the current published version. 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: 0 | Trial Use | 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.
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:
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.
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 | EvidenceVariable) | Inclusion and exclusion criteria | |
| actualGroup | Σ | 0..1 | Reference(Group) | Group of participants who were enrolled in study |
| comparisonGroup | 0..* | BackboneElement | Defined path through the study for a subject | |
| linkId | 0..1 | id | Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily | |
| name | 1..1 | string | Label for study comparisonGroup | |
| type | 0..1 | CodeableConcept | Categorization of study comparisonGroup Binding: Research Study Arm Type (Extensible) | |
| description | 0..1 | markdown | Short explanation of study path | |
| intendedExposure | 0..* | Reference(EvidenceVariable) | Interventions or exposures in this comparisonGroup or cohort | |
| observedGroup | 0..1 | Reference(Group) | Group of participants who were enrolled in study comparisonGroup | |
| objective | 0..* | BackboneElement | A goal for the study | |
| name | 0..1 | string | Label for the objective | |
| type | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: Research Study Objective Type (Preferred) | |
| description | 0..1 | markdown | Description of the objective | |
| outcomeMeasure | 0..* | BackboneElement | A variable measured during the study | |
| name | 0..1 | string | Label for the outcome | |
| type | 0..* | CodeableConcept | primary | secondary | exploratory Binding: Research Study Objective Type (Preferred) | |
| description | 0..1 | markdown | Description of the outcome | |
| reference | 0..1 | Reference(EvidenceVariable) | Structured outcome definition | |
| result | Σ | 0..* | Reference(EvidenceReport | Citation | 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(EvidenceVariable|Group) Inclusion and exclusion criteria --></eligibility> <actualGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study --></actualGroup> </recruitment> <comparisonGroup> <!-- 0..* Defined path through the study for a subject --> <linkId value="[id]"/><!-- 0..1 Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily --> <name value="[string]"/><!-- 1..1 Label for study comparisonGroup --> <type><!-- 0..1 CodeableConcept Categorization of study comparisonGroup --></type> <description value="[markdown]"/><!-- 0..1 Short explanation of study path --> <intendedExposure><!-- 0..* Reference(EvidenceVariable) Interventions or exposures in this comparisonGroup or cohort --></intendedExposure> <observedGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study comparisonGroup --></observedGroup> </comparisonGroup> <objective> <!-- 0..* A goal for the study --> <name value="[string]"/><!-- 0..1 Label for the objective --> <type><!-- 0..1 CodeableConcept primary | secondary | exploratory --></type> <description value="[markdown]"/><!-- 0..1 Description of the objective --> </objective> <outcomeMeasure> <!-- 0..* A variable measured during the study --> <name value="[string]"/><!-- 0..1 Label for the outcome --> <type><!-- 0..* CodeableConcept primary | secondary | exploratory --></type> <description value="[markdown]"/><!-- 0..1 Description of the outcome --> <reference><!-- 0..1 Reference(EvidenceVariable) Structured outcome definition --></reference> </outcomeMeasure> <result><!-- 0..* Reference(Citation|DiagnosticReport|EvidenceReport) 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(EvidenceVariable|Group) }, // Inclusion and exclusion criteria
"actualGroup" : { Reference(Group) } // Group of participants who were enrolled in study
},
"comparisonGroup" : [{ // Defined path through the study for a subject
"linkId" : "<id>", // Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
"name" : "<string>", // R! Label for study comparisonGroup
"type" : { CodeableConcept }, // Categorization of study comparisonGroup
"description" : "<markdown>", // Short explanation of study path
"intendedExposure" : [{ Reference(EvidenceVariable) }], // Interventions or exposures in this comparisonGroup or cohort
"observedGroup" : { Reference(Group) } // Group of participants who were enrolled in study comparisonGroup
}],
"objective" : [{ // A goal for the study
"name" : "<string>", // Label for the objective
"type" : { CodeableConcept }, // primary | secondary | exploratory
"description" : "<markdown>" // Description of the objective
}],
"outcomeMeasure" : [{ // A variable measured during the study
"name" : "<string>", // Label for the outcome
"type" : [{ CodeableConcept }], // primary | secondary | exploratory
"description" : "<markdown>", // Description of the outcome
"reference" : { Reference(EvidenceVariable) } // Structured outcome definition
}],
"result" : [{ Reference(Citation|DiagnosticReport|EvidenceReport) }] // Link to results generated during the study
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes from both R4 and R4B
| ResearchStudy | |
| ResearchStudy.url |
|
| ResearchStudy.version |
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| ResearchStudy.name |
|
| ResearchStudy.label |
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| ResearchStudy.label.type |
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| ResearchStudy.label.value |
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| ResearchStudy.date |
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| ResearchStudy.status |
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| ResearchStudy.primaryPurposeType |
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| ResearchStudy.studyDesign |
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| ResearchStudy.focus |
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| ResearchStudy.region |
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| ResearchStudy.descriptionSummary |
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| ResearchStudy.site |
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| ResearchStudy.classifier |
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| ResearchStudy.associatedParty |
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| ResearchStudy.associatedParty.name |
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| ResearchStudy.associatedParty.role |
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| ResearchStudy.associatedParty.period |
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| ResearchStudy.associatedParty.classifier |
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| ResearchStudy.associatedParty.party |
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| ResearchStudy.progressStatus |
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| ResearchStudy.progressStatus.state |
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| ResearchStudy.progressStatus.actual |
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| ResearchStudy.progressStatus.period |
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| ResearchStudy.whyStopped |
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| ResearchStudy.recruitment |
|
| ResearchStudy.recruitment.targetNumber |
|
| ResearchStudy.recruitment.actualNumber |
|
| ResearchStudy.recruitment.eligibility |
|
| ResearchStudy.recruitment.actualGroup |
|
| ResearchStudy.comparisonGroup |
|
| ResearchStudy.comparisonGroup.linkId |
|
| ResearchStudy.comparisonGroup.name |
|
| ResearchStudy.comparisonGroup.type |
|
| ResearchStudy.comparisonGroup.description |
|
| ResearchStudy.comparisonGroup.intendedExposure |
|
| ResearchStudy.comparisonGroup.observedGroup |
|
| ResearchStudy.objective.description |
|
| ResearchStudy.outcomeMeasure |
|
| ResearchStudy.outcomeMeasure.name |
|
| ResearchStudy.outcomeMeasure.type |
|
| ResearchStudy.outcomeMeasure.description |
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| ResearchStudy.outcomeMeasure.reference |
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| ResearchStudy.result |
|
| ResearchStudy.category |
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| ResearchStudy.contact |
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| ResearchStudy.location |
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| ResearchStudy.enrollment |
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| ResearchStudy.sponsor |
|
| ResearchStudy.principalInvestigator |
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| ResearchStudy.reasonStopped |
|
| ResearchStudy.arm |
|
See the Full Difference for further information
This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.
See R4 <--> R5 Conversion Maps (status = See Conversions Summary.)
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 | EvidenceVariable) | Inclusion and exclusion criteria | |
| actualGroup | Σ | 0..1 | Reference(Group) | Group of participants who were enrolled in study |
| comparisonGroup | 0..* | BackboneElement | Defined path through the study for a subject | |
| linkId | 0..1 | id | Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily | |
| name | 1..1 | string | Label for study comparisonGroup | |
| type | 0..1 | CodeableConcept | Categorization of study comparisonGroup Binding: Research Study Arm Type (Extensible) | |
| description | 0..1 | markdown | Short explanation of study path | |
| intendedExposure | 0..* | Reference(EvidenceVariable) | Interventions or exposures in this comparisonGroup or cohort | |
| observedGroup | 0..1 | Reference(Group) | Group of participants who were enrolled in study comparisonGroup | |
| objective | 0..* | BackboneElement | A goal for the study | |
| name | 0..1 | string | Label for the objective | |
| type | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: Research Study Objective Type (Preferred) | |
| description | 0..1 | markdown | Description of the objective | |
| outcomeMeasure | 0..* | BackboneElement | A variable measured during the study | |
| name | 0..1 | string | Label for the outcome | |
| type | 0..* | CodeableConcept | primary | secondary | exploratory Binding: Research Study Objective Type (Preferred) | |
| description | 0..1 | markdown | Description of the outcome | |
| reference | 0..1 | Reference(EvidenceVariable) | Structured outcome definition | |
| result | Σ | 0..* | Reference(EvidenceReport | Citation | DiagnosticReport) | Link to results generated during the study |
| Documentation for this format | ||||
See the Extensions for this resource
XML Template
<ResearchStudy xmlns="http://hl7.org/fhir">
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(EvidenceVariable|Group) }, // Inclusion and exclusion criteria
"actualGroup" : { Reference(Group) } // Group of participants who were enrolled in study
},
"comparisonGroup" : [{ // Defined path through the study for a subject
"linkId" : "<id>", // Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
"name" : "<string>", // R! Label for study comparisonGroup
"type" : { CodeableConcept }, // Categorization of study comparisonGroup
"description" : "<markdown>", // Short explanation of study path
"intendedExposure" : [{ Reference(EvidenceVariable) }], // Interventions or exposures in this comparisonGroup or cohort
"observedGroup" : { Reference(Group) } // Group of participants who were enrolled in study comparisonGroup
}],
"objective" : [{ // A goal for the study
"name" : "<string>", // Label for the objective
"type" : { CodeableConcept }, // primary | secondary | exploratory
"description" : "<markdown>" // Description of the objective
}],
"outcomeMeasure" : [{ // A variable measured during the study
"name" : "<string>", // Label for the outcome
"type" : [{ CodeableConcept }], // primary | secondary | exploratory
"description" : "<markdown>", // Description of the outcome
"reference" : { Reference(EvidenceVariable) } // Structured outcome definition
}],
"result" : [{ Reference(Citation|DiagnosticReport|EvidenceReport) }] // Link to results generated during the study
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes from both R4 and R4B
| ResearchStudy | |
| ResearchStudy.url |
|
| ResearchStudy.version |
|
| ResearchStudy.name |
|
| ResearchStudy.label |
|
| ResearchStudy.label.type |
|
| ResearchStudy.label.value |
|
| ResearchStudy.date |
|
| ResearchStudy.status |
|
| ResearchStudy.primaryPurposeType |
|
| ResearchStudy.studyDesign |
|
| ResearchStudy.focus |
|
| ResearchStudy.region |
|
| ResearchStudy.descriptionSummary |
|
| ResearchStudy.site |
|
| ResearchStudy.classifier |
|
| ResearchStudy.associatedParty |
|
| ResearchStudy.associatedParty.name |
|
| ResearchStudy.associatedParty.role |
|
| ResearchStudy.associatedParty.period |
|
| ResearchStudy.associatedParty.classifier |
|
| ResearchStudy.associatedParty.party |
|
| ResearchStudy.progressStatus |
|
| ResearchStudy.progressStatus.state |
|
| ResearchStudy.progressStatus.actual |
|
| ResearchStudy.progressStatus.period |
|
| ResearchStudy.whyStopped |
|
| ResearchStudy.recruitment |
|
| ResearchStudy.recruitment.targetNumber |
|
| ResearchStudy.recruitment.actualNumber |
|
| ResearchStudy.recruitment.eligibility |
|
| ResearchStudy.recruitment.actualGroup |
|
| ResearchStudy.comparisonGroup |
|
| ResearchStudy.comparisonGroup.linkId |
|
| ResearchStudy.comparisonGroup.name |
|
| ResearchStudy.comparisonGroup.type |
|
| ResearchStudy.comparisonGroup.description |
|
| ResearchStudy.comparisonGroup.intendedExposure |
|
| ResearchStudy.comparisonGroup.observedGroup |
|
| ResearchStudy.objective.description |
|
| ResearchStudy.outcomeMeasure |
|
| ResearchStudy.outcomeMeasure.name |
|
| ResearchStudy.outcomeMeasure.type |
|
| ResearchStudy.outcomeMeasure.description |
|
| ResearchStudy.outcomeMeasure.reference |
|
| ResearchStudy.result |
|
| ResearchStudy.category |
|
| ResearchStudy.contact |
|
| ResearchStudy.location |
|
| ResearchStudy.enrollment |
|
| ResearchStudy.sponsor |
|
| ResearchStudy.principalInvestigator |
|
| ResearchStudy.reasonStopped |
|
| ResearchStudy.arm |
|
See the Full Difference for further information
This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.
See R4 <--> R5 Conversion Maps (status = See Conversions Summary.)
Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis
| Path | ValueSet | Type | Documentation |
|---|---|---|---|
| ResearchStudy.label.type | TitleType | Extensible | Used to express the reason and specific aspect for the variant title, such as language and specific language. |
| ResearchStudy.status | PublicationStatus | Required | The lifecycle status of an artifact. |
| ResearchStudy.primaryPurposeType | ResearchStudyPrimaryPurposeType (a valid code from ResearchStudy Primary Purpose Type Code System) | Preferred | Codes for the main intent of the study. |
| ResearchStudy.phase | ResearchStudyPhase (a valid code from ResearchStudy Phase Code System) | Example | Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. |
| ResearchStudy.studyDesign | StudyDesign | Preferred | This is a set of terms for study design characteristics. |
| ResearchStudy.focus | ResearchStudyFocusType (a valid code from ResearchStudy Focus Type Code System) | Example | Codes for the main intent of the study. |
| ResearchStudy.condition | ConditionProblemDiagnosisCodes | Example | Example value set for Condition/Problem/Diagnosis codes. |
| ResearchStudy.keyword | ?? | Example | |
| ResearchStudy.region | JurisdictionValueSet | Extensible | 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 |
| ResearchStudy.classifier | ResearchStudyClassifiers (a valid code from ResearchStudy Classifiers Code System) | Example | Codes that convey the type of label that is provided. |
| ResearchStudy.associatedParty.role | ResearchStudyPartyRole | Extensible | This is a ResearchStudy's party role. |
| ResearchStudy.associatedParty.classifier | ResearchStudyPartyOrgType (a valid code from ResearchStudy Party Organization Type Code System) | Example | This is a ResearchStudy's party organization type. |
| ResearchStudy.progressStatus.state | ResearchStudyStatus | Extensible | Codes that convey the current status of the research study. |
| ResearchStudy.whyStopped | ResearchStudyReasonStopped (a valid code from ResearchStudy Reason Stopped Code System) | Example | Codes for why the study ended prematurely. |
| ResearchStudy.comparisonGroup.type | ResearchStudyArmType (a valid code from ResearchStudy Arm Type Code System) | Extensible | Codes for the main intent of the study. |
| ResearchStudy.objective.type | ResearchStudyObjectiveType (a valid code from ResearchStudy Objective Type Code System) | Preferred | Codes for the kind of study objective. |
| ResearchStudy.outcomeMeasure.type | ResearchStudyObjectiveType (a valid code from ResearchStudy Objective Type Code System) | Preferred | Codes for the kind of study objective. |
The following diagram reflects the "typical" state machine for ResearchStudy.
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, EvidenceVariable) | |
| 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 |
FHIR ®© HL7.org 2011+. FHIR R5 hl7.fhir.core#5.0.0 generated on Sun, Mar 26, 2023 15:25+1100.
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