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StructureDefinitionsResearchStudy

http://hl7.org/fhir/StructureDefinition/ResearchStudy|4.0.1

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.
StructureJSONDependenciesFHIRSchemaOther VersionsDependant (0)ElementsSummary
NameFlagsCardTypeDescription & Constraints
ResearchStudy
0..*Investigation to increase healthcare-related patient-independent knowledge
 
identifier
Σ
0..*IdentifierBusiness Identifier for study
 
title
Σ
0..1stringName for this study
 
protocol
Σ
0..*ReferenceSteps followed in executing study
 
partOf
Σ
0..*ReferencePart of larger study
 
status *
?!Σ
1..1codeactive | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn ResearchStudyStatus (required)
 
primaryPurposeType
Σ
0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility ResearchStudyPrimaryPurposeType (extensible)
 
phase
Σ
0..1CodeableConceptn-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..*CodeableConceptClassifications for the study ResearchStudyCategory (example)
 
focus
Σ
0..*CodeableConceptDrugs, devices, etc. under study ResearchStudyFocus (example)
 
condition
Σ
0..*CodeableConceptCondition being studied ConditionCode (example)
 
contact
Σ
0..*ContactDetailContact details for the study
 
relatedArtifact
0..*RelatedArtifactReferences and dependencies
 
keyword
Σ
0..*CodeableConceptUsed to search for the study ResearchStudyKeyword (example)
 
location
Σ
0..*CodeableConceptGeographic region(s) for study Jurisdiction (extensible)
 
description
0..1markdownWhat this is study doing
 
enrollment
Σ
0..*ReferenceInclusion & exclusion criteria
 
period
Σ
0..1PeriodWhen the study began and ended
 
sponsor
Σ
0..1ReferenceOrganization that initiates and is legally responsible for the study
 
principalInvestigator
Σ
0..1ReferenceResearcher who oversees multiple aspects of the study
 
site
Σ
0..*ReferenceFacility where study activities are conducted
 
reasonStopped
Σ
0..1CodeableConceptaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design ResearchStudyReasonStopped (example)
 
note
0..*AnnotationComments made about the study
 
arm
0..*BackboneElementDefined path through the study for a subject
 
 
name *
1..1stringLabel for study arm
 
 
type
0..1CodeableConceptCategorization of study arm
 
 
description
0..1stringShort explanation of study path
 
objective
0..*BackboneElementA goal for the study
 
 
name
0..1stringLabel for the objective
 
 
type
0..1CodeableConceptprimary | secondary | exploratory ResearchStudyObjectiveType (preferred)