NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy TUDomainResourceInvestigation to increase healthcare-related patient-independent knowledge
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness Identifier for study
... title Σ0..1stringName for this study
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study
... partOf Σ0..*Reference(ResearchStudy)Part of larger study
... status ?!Σ1..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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn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 Σ0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
ResearchStudyPrimaryPurposeType (Extensible)
... phase Σ0..1CodeableConceptn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
ResearchStudyPhase (Example)
... category Σ0..*CodeableConceptClassifications for the study
... focus Σ0..*CodeableConceptDrugs, devices, etc. under study
... condition Σ0..*CodeableConceptCondition being studied
Condition/Problem/Diagnosis Codes (Example)
... contact Σ0..*ContactDetailContact details for the study
... relatedArtifact 0..*RelatedArtifactReferences and dependencies
... keyword Σ0..*CodeableConceptUsed to search for the study
... location Σ0..*CodeableConceptGeographic region(s) for study
Jurisdiction (Extensible)
... description 0..1markdownWhat this is study doing
... enrollment Σ0..*Reference(Group)Inclusion & exclusion criteria
... period Σ0..1PeriodWhen the study began and ended
... sponsor Σ0..1Reference(Organization)Organization that initiates and is legally responsible for the study
... principalInvestigator Σ0..1Reference(Practitioner | PractitionerRole)Researcher who oversees multiple aspects of the study
... site Σ0..*Reference(Location)Facility where study activities are conducted
... reasonStopped Σ0..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)

doco Documentation for this format