Release 5 Draft Ballot
AdministrationThis page is part of the FHIR Specification (v4.6.0: R5 Draft Ballot - see ballot notes). 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: 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 or stability data about drug products or drug substances.
Trial-Use Note: In terms of scope and usage, the BR and RR workgroup wish to draw the attention of reviewers and implementers to the following issue:
- This is a major restructuring of the resource. We are seeking input from the implementation community on the appropriateness of these changes
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:
ResearchStudy is aimed at all forms of studies. For some study types specific extensions have been defined
Extension: RelatesTo
Many clinical studies have a component sub-study and the partOf attribute should be used for this. There may also be documents such as a PDF of the protocol or consent forms and these should be linked using relatedAretfact. However there may be more complex relations to other studies people organizations or artefacts and the RelatesTo extension is provided to record these.
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.
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 | |
  url | 0..1 | uri | Canonical identifier for this study resource | |
 identifier | Σ | 0..* | Identifier | Business Identifier for study |
| version | 0..1 | string | Business identifier for the study record | |
| name | 0..1 | string | Name for this study (computer friendly) | |
| title | Σ | 0..1 | string | Name for this study (for computers) |
  label | 0..* | BackboneElement | Additional names for the study | |
 type | 0..1 | CodeableConcept | short | public | scientific ResearchStudyTitleType (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) |
| category | Σ | 0..* | CodeableConcept | Classifications for the study ResearchStudyCategory (Example) |
| 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) |
| location | Σ | 0..* | CodeableConcept | Geographic region(s) for study Jurisdiction (Extensible) |
| descriptionSummary | 0..1 | markdown | A brief summary of the study description | |
| description | 0..1 | markdown | What this is study doing | |
| period | Σ | 0..1 | Period | When the study began and ended |
| contact | Σ | 0..* | ContactDetail | Contact details for the study |
| 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 | ResearchStudy | Organization) | Facility where study activities are conducted |
| note | 0..* | Annotation | Comments made about the study | |
| classification | 0..* | BackboneElement | Classification for the study | |
| type | 0..1 | CodeableConcept | phase | category | keyword ResearchStudyCLassificationType (Extensible) | |
| classifier | 0..* | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 ResearchStudyClassificationClassifier (Extensible) | |
| associatedParty | 0..* | BackboneElement | Sponsors, collaborators, and other parties | |
| name | 0..1 | string | Name of associated party | |
| role | 1..1 | CodeableConcept | sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair ResearchStudyPartyType (Extensible) | |
| classifier | 0..* | CodeableConcept | nih | fda ResearchStudyPartyOrganizationType (Extensible) | |
| party | 0..1 | Reference(Practitioner | PractitionerRole | Organization) | Individual or organization associated with study (use practitionerRole to specify their organisation) | |
| currentState | 0..* | CodeableConcept | 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 (Extensible) | |
| statusDate | 0..* | BackboneElement | Status of study with time for that status | |
| activity | 1..1 | CodeableConcept | Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting ResearchStudyStatusActivity (Extensible) | |
| actual | 0..1 | boolean | Actual if true else anticipated | |
| period | 1..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) | 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 | |
 type | 0..1 | CodeableConcept | registry-page|recruitment-page|contact-page ResearchStudyUrlType (Extensible) | |
| url | 1..1 | uri | The location address | |
| 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 --> <url value="[uri]"/><!-- 0..1 Canonical identifier for this study resource --> <identifier><!-- 0..* Identifier Business Identifier for study --></identifier> <version value="[string]"/><!-- 0..1 Business identifier for the study record --> <name value="[string]"/><!-- 0..1 Name for this study (computer friendly) --> <title value="[string]"/><!-- 0..1 Name for this study (for computers) --> <label> <!-- 0..* Additional names for the study --> <type><!-- 0..1 CodeableConcept short | public | scientific
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>", // Business identifier for the study record
"name" : "<string>", // Name for this study (computer friendly)
"title" : "<string>", // Name for this study (for computers)
"label" : [{ // Additional names for the study
"type" : { CodeableConcept }, // short | public | scientific
"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
"category" : [{ CodeableConcept }], // Classifications for the study
"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
"location" : [{ CodeableConcept }], // Geographic region(s) for study
"descriptionSummary" : "<markdown>", // A brief summary of the study description
"description" : "<markdown>", // What this is study doing
"period" : { Period }, // When the study began and ended
"contact" : [{ ContactDetail }], // Contact details for the study
"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|Organization|ResearchStudy) }], // Facility where study activities are conducted
"note" : [{ Annotation }], // Comments made about the study
"classification" : [{ // Classification for the study
"type" : { CodeableConcept }, // phase | category | keyword
"classifier" : [{ CodeableConcept }] // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
}],
"associatedParty" : [{ // Sponsors, collaborators, and other parties
"name" : "<string>", // Name of associated party
"role" : { CodeableConcept }, // R! sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair
"classifier" : [{ CodeableConcept }], // nih | fda
"party" : { Reference(Organization|Practitioner|PractitionerRole) } // Individual or organization associated with study (use practitionerRole to specify their organisation)
}],
"currentState" : [{ CodeableConcept }], // 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
"statusDate" : [{ // Status of study with time for that status
"activity" : { CodeableConcept }, // R! Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting
"actual" : <boolean>, // Actual if true else anticipated
"period" : { Period } // R! Date range
}],
"whyStopped" : { CodeableConcept }, // accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
"recruitment" : { // Target or actual group of participants enrolled in study
"targetNumber" : "<unsignedInt>", // Estimated total number of participants to be enrolled
"actualNumber" : "<unsignedInt>", // Actual total number of participants enrolled in study
"eligibility" : { Reference(Group) }, // Inclusion and exclusion criteria
"actualGroup" : { Reference(Group) } // Group of participants who were enrolled in study
},
"comparisonGroup" : [{ // Defined path through the study for a subject
// 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
"type" : { CodeableConcept }, // registry-page|recruitment-page|contact-page
"url" : "<uri>" // R! The location address
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes since R3
| ResearchStudy | |
| ResearchStudy.url |
|
| ResearchStudy.version |
|
| ResearchStudy.name |
|
| ResearchStudy.label |
|
| ResearchStudy.label.type |
|
| ResearchStudy.label.value |
|
| ResearchStudy.date |
|
| ResearchStudy.status |
|
| ResearchStudy.focus |
|
| ResearchStudy.focus.productCode |
|
| ResearchStudy.focus.focusType |
|
| ResearchStudy.focus.factor |
|
| ResearchStudy.descriptionSummary |
|
| ResearchStudy.site |
|
| ResearchStudy.classification |
|
| ResearchStudy.classification.type |
|
| ResearchStudy.classification.classifier |
|
| ResearchStudy.associatedParty |
|
| ResearchStudy.associatedParty.name |
|
| ResearchStudy.associatedParty.role |
|
| ResearchStudy.associatedParty.classifier |
|
| ResearchStudy.associatedParty.party |
|
| ResearchStudy.currentState |
|
| ResearchStudy.statusDate |
|
| ResearchStudy.statusDate.activity |
|
| ResearchStudy.statusDate.actual |
|
| ResearchStudy.statusDate.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.type |
|
| ResearchStudy.webLocation.url |
|
| ResearchStudy.enrollment |
|
| 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 | Business identifier for the study record | |
| name | 0..1 | string | Name for this study (computer friendly) | |
| title | Σ | 0..1 | string | Name for this study (for computers) |
| label | 0..* | BackboneElement | Additional names for the study | |
| type | 0..1 | CodeableConcept | short | public | scientific ResearchStudyTitleType (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) |
| category | Σ | 0..* | CodeableConcept | Classifications for the study ResearchStudyCategory (Example) |
| 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) |
| location | Σ | 0..* | CodeableConcept | Geographic region(s) for study Jurisdiction (Extensible) |
| descriptionSummary | 0..1 | markdown | A brief summary of the study description | |
| description | 0..1 | markdown | What this is study doing | |
| period | Σ | 0..1 | Period | When the study began and ended |
| contact | Σ | 0..* | ContactDetail | Contact details for the study |
| 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 | ResearchStudy | Organization) | Facility where study activities are conducted |
| note | 0..* | Annotation | Comments made about the study | |
| classification | 0..* | BackboneElement | Classification for the study | |
| type | 0..1 | CodeableConcept | phase | category | keyword ResearchStudyCLassificationType (Extensible) | |
| classifier | 0..* | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 ResearchStudyClassificationClassifier (Extensible) | |
| associatedParty | 0..* | BackboneElement | Sponsors, collaborators, and other parties | |
| name | 0..1 | string | Name of associated party | |
| role | 1..1 | CodeableConcept | sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair ResearchStudyPartyType (Extensible) | |
| classifier | 0..* | CodeableConcept | nih | fda ResearchStudyPartyOrganizationType (Extensible) | |
| party | 0..1 | Reference(Practitioner | PractitionerRole | Organization) | Individual or organization associated with study (use practitionerRole to specify their organisation) | |
| currentState | 0..* | CodeableConcept | 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 (Extensible) | |
| statusDate | 0..* | BackboneElement | Status of study with time for that status | |
| activity | 1..1 | CodeableConcept | Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting ResearchStudyStatusActivity (Extensible) | |
| actual | 0..1 | boolean | Actual if true else anticipated | |
| period | 1..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) | 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 | |
| type | 0..1 | CodeableConcept | registry-page|recruitment-page|contact-page ResearchStudyUrlType (Extensible) | |
| url | 1..1 | uri | The location address | |
| Documentation for this format | ||||
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>", // Business identifier for the study record
"name" : "<string>", // Name for this study (computer friendly)
"title" : "<string>", // Name for this study (for computers)
"label" : [{ // Additional names for the study
"type" : { CodeableConcept }, // short | public | scientific
"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
"category" : [{ CodeableConcept }], // Classifications for the study
"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
"location" : [{ CodeableConcept }], // Geographic region(s) for study
"descriptionSummary" : "<markdown>", // A brief summary of the study description
"description" : "<markdown>", // What this is study doing
"period" : { Period }, // When the study began and ended
"contact" : [{ ContactDetail }], // Contact details for the study
"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|Organization|ResearchStudy) }], // Facility where study activities are conducted
"note" : [{ Annotation }], // Comments made about the study
"classification" : [{ // Classification for the study
"type" : { CodeableConcept }, // phase | category | keyword
"classifier" : [{ CodeableConcept }] // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
}],
"associatedParty" : [{ // Sponsors, collaborators, and other parties
"name" : "<string>", // Name of associated party
"role" : { CodeableConcept }, // R! sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair
"classifier" : [{ CodeableConcept }], // nih | fda
"party" : { Reference(Organization|Practitioner|PractitionerRole) } // Individual or organization associated with study (use practitionerRole to specify their organisation)
}],
"currentState" : [{ CodeableConcept }], // 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
"statusDate" : [{ // Status of study with time for that status
"activity" : { CodeableConcept }, // R! Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting
"actual" : <boolean>, // Actual if true else anticipated
"period" : { Period } // R! Date range
}],
"whyStopped" : { CodeableConcept }, // accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
"recruitment" : { // Target or actual group of participants enrolled in study
"targetNumber" : "<unsignedInt>", // Estimated total number of participants to be enrolled
"actualNumber" : "<unsignedInt>", // Actual total number of participants enrolled in study
"eligibility" : { Reference(Group) }, // Inclusion and exclusion criteria
"actualGroup" : { Reference(Group) } // Group of participants who were enrolled in study
},
"comparisonGroup" : [{ // Defined path through the study for a subject
// 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
"type" : { CodeableConcept }, // registry-page|recruitment-page|contact-page
"url" : "<uri>" // R! The location address
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes since Release 3
| ResearchStudy | |
| ResearchStudy.url |
|
| ResearchStudy.version |
|
| ResearchStudy.name |
|
| ResearchStudy.label |
|
| ResearchStudy.label.type |
|
| ResearchStudy.label.value |
|
| ResearchStudy.date |
|
| ResearchStudy.status |
|
| ResearchStudy.focus |
|
| ResearchStudy.focus.productCode |
|
| ResearchStudy.focus.focusType |
|
| ResearchStudy.focus.factor |
|
| ResearchStudy.descriptionSummary |
|
| ResearchStudy.site |
|
| ResearchStudy.classification |
|
| ResearchStudy.classification.type |
|
| ResearchStudy.classification.classifier |
|
| ResearchStudy.associatedParty |
|
| ResearchStudy.associatedParty.name |
|
| ResearchStudy.associatedParty.role |
|
| ResearchStudy.associatedParty.classifier |
|
| ResearchStudy.associatedParty.party |
|
| ResearchStudy.currentState |
|
| ResearchStudy.statusDate |
|
| ResearchStudy.statusDate.activity |
|
| ResearchStudy.statusDate.actual |
|
| ResearchStudy.statusDate.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.type |
|
| ResearchStudy.webLocation.url |
|
| ResearchStudy.enrollment |
|
| 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.)
See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis a
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 | |
| 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 | |
| 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) | |
| 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 | |
| site | reference | Facility where study activities are conducted | ResearchStudy.site (Organization, Location, ResearchStudy) | |
| sponsor | reference | Organization that initiates and is legally responsible for the study | ResearchStudy.sponsor (Organization) | |
| status N | 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 N | string | Name for this study | ResearchStudy.title |
FHIR ®© HL7.org 2011+. FHIR R5 Draft Ballot hl7.fhir.core#4.6.0 generated on Thu, Apr 15, 2021 12:29+1000.
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