Name Flags Card. Type Description & Constraints doco
. . ResearchStudy TU DomainResource Investigation to increase healthcare-related patient-independent knowledge
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
. . . identifier Σ 0..* Identifier Business Identifier for study
. . . title Σ 0..1 string Name for this study
. . . protocol Σ 0..* Reference( PlanDefinition) Steps followed in executing study
. . . partOf Σ 0..* Reference( ResearchStudy) Part of larger study
. . . status ?! Σ 1..1 code 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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn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 ( 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
. . . focus Σ 0..* CodeableConcept Drugs, devices, etc. under study
. . . condition Σ 0..* CodeableConcept Condition being studied
Condition/Problem/Diagnosis Codes ( Example)
. . . contact Σ 0..* ContactDetail Contact details for the study
. . . relatedArtifact 0..* RelatedArtifact References and dependencies
. . . keyword Σ 0..* CodeableConcept Used to search for the study
. . . location Σ 0..* CodeableConcept Geographic region(s) for study
Jurisdiction ( Extensible)
. . . description 0..1 markdown What this is study doing
. . . enrollment Σ 0..* Reference( Group) Inclusion & exclusion criteria
. . . period Σ 0..1 Period When the study began and ended
. . . 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) Facility where study activities are conducted
. . . reasonStopped 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)
. . . note 0..* Annotation Comments made about the study
. . . arm 0..* BackboneElement Defined path through the study for a subject
. . . . name 1..1 string Label for study arm
. . . . type 0..1 CodeableConcept Categorization of study arm
. . . . description 0..1 string Short explanation of study path
. . . 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)

doco Documentation for this format