Release 5 Ballot
AdministrationThis page is part of the FHIR Specification (v5.0.0-ballot: FHIR R5 Ballot Preview). 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: 0 | Trial Use | Security Category: Business | Compartments: Not linked to any 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.
Note to Balloters: Ballot Questions: In terms of scope and usage, the BR&R workgroup wish to draw the attention of reviewers and implementers to the following topics:
- The resource has been refined and revised to remove duplication in few areas. We are seeking input from the community on the appropriateness of these changes.
- One major topic that the WG has discussed is the scope of this resource. One proposal under consideration is that the ResearchStudy resource would be a base resource that supports all kinds of research. Use case specific profiles would be developed in the near future to support a) Regulated Clinical Trial Profile, b) Basic Research Study Profile, etc. Below is an illustration of the proposal under consideration.
- WG seeks input in how research study sites should be represented in FHIR. There are two proposals under consideration. Option 1: Develop a ResearchStudySite Profile of ResearchStudy resource, Option 2: Develop a NEW FHIR resource called ResearchStudySite. For now, the WG is doing analysis to see if the profile option (Option 1) would work. All input is welcome.
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 TitleType (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 and dependencies | |
| date | 0..1 | dateTime | Date the resource last changed | |
| status | ?!Σ | 1..1 | code | draft | active | retired | unknown PublicationStatus (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) |
| studyDesign | Σ | 0..* | CodeableConcept | Classifications of the study design characteristics Study Design (Preferred) |
| focus | 0..* | BackboneElement | Drugs, devices, etc. under study | |
| productCode | Σ | 0..1 | CodeableConcept | Identification of product under study ResearchStudyFocus (Example) |
| focusType | 0..* | CodeableConcept | medication | device | intervention | factor ResearchStudyFocusType (Extensible) | |
| factor | 0..1 | markdown | An independent variable manipulated by the experimentalist | |
| condition | Σ | 0..* | CodeableConcept | Condition being studied Condition/Problem/Diagnosis Codes (Example) |
| keyword | Σ | 0..* | CodeableConcept | Used to search for the study ResearchStudyKeyword (Example) |
| region | Σ | 0..* | CodeableConcept | Geographic area for the study Jurisdiction (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 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 Research Study Party Role (Extensible) | |
| period | 0..* | Period | When active in the role | |
| classifier | 0..* | CodeableConcept | nih | fda | government | nonprofit | academic | industry 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) ResearchStudyStatus (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 ResearchStudyReasonStopped (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 | |
 identifier[x] | 0..1 | Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily | ||
| identifierUri | uri | |||
| identifierIdentifier | Identifier | |||
| name | 1..1 | string | Label for study comparisonGroup | |
| type | 0..1 | CodeableConcept | Categorization of study comparisonGroup ResearchStudyArmType (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 ResearchStudyObjectiveType (Preferred) | |
| description | 0..1 | markdown | Description of the objective | |
| outcomeMeasure | 0..* | BackboneElement | An outcome or planned variable to measure during the study | |
| name | 0..1 | string | Label for the outcome | |
| type | 0..* | CodeableConcept | primary | secondary | exploratory ResearchStudyObjectiveType (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 |
 webLocation | 0..* | BackboneElement | Archive location for the study | |
 classifier | 0..1 | CodeableConcept | registry-page|recruitment-page|contact-page ArtifactUrlClassifier (Example) | |
| url | 1..1 | uri | The location address | |
| 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 and dependencies --></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..* Drugs, devices, etc. under study --> <productCode><!-- 0..1 CodeableConcept Identification of product under study --></productCode> <focusType><!-- 0..* CodeableConcept medication | device | intervention | factor --></focusType> <factor value="[markdown]"/><!-- 0..1 An independent variable manipulated by the experimentalist --> </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 --> <identifier[x]><!-- 0..1 uri|Identifier Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily --></identifier[x]> <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..* An outcome or planned variable to measure 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> <webLocation> <!-- 0..* Archive location for the study --> <classifier><!-- 0..1 CodeableConcept registry-page|recruitment-page|contact-page --></classifier> <url value="[uri]"/><!-- 1..1 The location address --> </webLocation> </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 and dependencies
"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" : [{ // Drugs, devices, etc. under study
"productCode" : { CodeableConcept }, // Identification of product under study
"focusType" : [{ CodeableConcept }], // medication | device | intervention | factor
"factor" : "<markdown>" // An independent variable manipulated by the experimentalist
}],
"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
// identifier[x]:
Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily. One of these 2:
"identifierUri" : "<uri>",
"identifierIdentifier" : { Identifier },
"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" : [{ // An outcome or planned variable to measure 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
"webLocation" : [{ // Archive location for the study
"classifier" : { CodeableConcept }, // registry-page|recruitment-page|contact-page
"url" : "<uri>" // R! The location address
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes since R4
| 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.focus.productCode |
|
| ResearchStudy.focus.focusType |
|
| ResearchStudy.focus.factor |
|
| 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 |
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| ResearchStudy.progressStatus.period |
|
| ResearchStudy.whyStopped |
|
| ResearchStudy.recruitment |
|
| ResearchStudy.recruitment.targetNumber |
|
| ResearchStudy.recruitment.actualNumber |
|
| ResearchStudy.recruitment.eligibility |
|
| ResearchStudy.recruitment.actualGroup |
|
| ResearchStudy.comparisonGroup |
|
| ResearchStudy.comparisonGroup.identifier[x] |
|
| 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.webLocation |
|
| ResearchStudy.webLocation.classifier |
|
| ResearchStudy.webLocation.url |
|
| 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 as XML or JSON.
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 | |
| 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 TitleType (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 and dependencies | |
| date | 0..1 | dateTime | Date the resource last changed | |
| status | ?!Σ | 1..1 | code | draft | active | retired | unknown PublicationStatus (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) |
| studyDesign | Σ | 0..* | CodeableConcept | Classifications of the study design characteristics Study Design (Preferred) |
| focus | 0..* | BackboneElement | Drugs, devices, etc. under study | |
| productCode | Σ | 0..1 | CodeableConcept | Identification of product under study ResearchStudyFocus (Example) |
| focusType | 0..* | CodeableConcept | medication | device | intervention | factor ResearchStudyFocusType (Extensible) | |
| factor | 0..1 | markdown | An independent variable manipulated by the experimentalist | |
| condition | Σ | 0..* | CodeableConcept | Condition being studied Condition/Problem/Diagnosis Codes (Example) |
| keyword | Σ | 0..* | CodeableConcept | Used to search for the study ResearchStudyKeyword (Example) |
| region | Σ | 0..* | CodeableConcept | Geographic area for the study Jurisdiction (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 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 Research Study Party Role (Extensible) | |
| period | 0..* | Period | When active in the role | |
| classifier | 0..* | CodeableConcept | nih | fda | government | nonprofit | academic | industry 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) ResearchStudyStatus (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 ResearchStudyReasonStopped (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 | |
| identifier[x] | 0..1 | Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily | ||
| identifierUri | uri | |||
| identifierIdentifier | Identifier | |||
| name | 1..1 | string | Label for study comparisonGroup | |
| type | 0..1 | CodeableConcept | Categorization of study comparisonGroup ResearchStudyArmType (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 ResearchStudyObjectiveType (Preferred) | |
| description | 0..1 | markdown | Description of the objective | |
| outcomeMeasure | 0..* | BackboneElement | An outcome or planned variable to measure during the study | |
| name | 0..1 | string | Label for the outcome | |
| type | 0..* | CodeableConcept | primary | secondary | exploratory ResearchStudyObjectiveType (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 |
| webLocation | 0..* | BackboneElement | Archive location for the study | |
| classifier | 0..1 | CodeableConcept | registry-page|recruitment-page|contact-page ArtifactUrlClassifier (Example) | |
| url | 1..1 | uri | The location address | |
| 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 and dependencies
"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" : [{ // Drugs, devices, etc. under study
"productCode" : { CodeableConcept }, // Identification of product under study
"focusType" : [{ CodeableConcept }], // medication | device | intervention | factor
"factor" : "<markdown>" // An independent variable manipulated by the experimentalist
}],
"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
// identifier[x]:
Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily. One of these 2:
"identifierUri" : "<uri>",
"identifierIdentifier" : { Identifier },
"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" : [{ // An outcome or planned variable to measure 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
"webLocation" : [{ // Archive location for the study
"classifier" : { CodeableConcept }, // registry-page|recruitment-page|contact-page
"url" : "<uri>" // R! The location address
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes since Release 4
| 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.focus.productCode |
|
| ResearchStudy.focus.focusType |
|
| ResearchStudy.focus.factor |
|
| 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.identifier[x] |
|
| 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.webLocation |
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| ResearchStudy.webLocation.classifier |
|
| ResearchStudy.webLocation.url |
|
| 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 as XML or JSON.
See R3 <--> R4 Conversion Maps (status = 1 test that all execute ok. All tests pass round-trip testing and all r3 resources are valid.)
Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis
| Path | Definition | Type | Reference |
|---|---|---|---|
| ResearchStudy.label.type | Used to express the reason and specific aspect for the variant title, such as language and specific language. | Extensible | TitleType |
| ResearchStudy.status | The lifecycle status of an artifact. | Required | PublicationStatus |
| 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.studyDesign | This is a set of terms for study design characteristics. | Preferred | StudyDesign |
| ResearchStudy.focus.productCode | Example | ?? | |
| ResearchStudy.focus.focusType | Codes for the main intent of the study. | Extensible | ResearchStudyFocusType |
| ResearchStudy.condition | Example value set for Condition/Problem/Diagnosis codes. | Example | Condition/Problem/DiagnosisCodes |
| ResearchStudy.keyword | Example | ?? | |
| ResearchStudy.region | 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 | Extensible | Jurisdiction ValueSet |
| ResearchStudy.classifier | Codes that convey the type of label that is provided. | Example | ResearchStudyClassifiers |
| ResearchStudy.associatedParty.role | This is a ResearchStudy's party role. | Extensible | ResearchStudyPartyRole |
| ResearchStudy.associatedParty.classifier | This is a ResearchStudy's party organization type. | Example | ResearchStudyPartyOrgType |
| ResearchStudy.progressStatus.state | Codes that convey the current status of the research study. | Extensible | ResearchStudyStatus |
| ResearchStudy.whyStopped | Codes for why the study ended prematurely. | Example | ResearchStudyReasonStopped |
| ResearchStudy.comparisonGroup.type | Codes for the main intent of the study. | Extensible | ResearchStudyArmType |
| ResearchStudy.objective.type | Codes for the kind of study objective. | Preferred | ResearchStudyObjectiveType |
| ResearchStudy.outcomeMeasure.type | Codes for the kind of study objective. | Preferred | ResearchStudyObjectiveType |
| ResearchStudy.webLocation.classifier | Code the reason for different URLs, eg abstract and full-text. | Example | ArtifactUrlClassifier |
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 |
| condition | token | Condition being studied | ResearchStudy.condition | |
| 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 | |
| partof | reference | Part of larger study | ResearchStudy.partOf (ResearchStudy) | |
| 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 N | 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 | |
| title N | string | Name for this study | ResearchStudy.title |
FHIR ®© HL7.org 2011+. FHIR R5 Ballot hl7.fhir.core#5.0.0-ballot generated on Wed, Sep 7, 2022 11:11+1000.
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