Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
ResearchSubject | TU | DomainResource | Participant or object which is the recipient of investigative activities in a study
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension |
|
identifier | Σ | 0..* | Identifier | Business Identifier for research subject in a study
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status | ?! Σ | 1..1 | code | draft | active | retired | unknown
Binding: PublicationStatus ( Required) |
period | Σ | 0..1 | Period | Start and end of participation
|
study | Σ | 1..1 | Reference( ResearchStudy) | Study subject is part of
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subject | Σ | 1..1 | Reference( Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct) | Who or what is part of study
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subjectState | 0..* | BackboneElement | A duration in the lifecycle of the ResearchSubject within a ResearchStudy
|
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code | 1..1 | CodeableConcept | candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study
Binding: Research Subject State ( Extensible) |
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startDate | 1..1 | dateTime | The date a research subject entered the given state
|
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endDate | 0..1 | dateTime | The date a research subject exited or left the given state
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reason | 0..1 | CodeableConcept | State change reason
Binding: StateChangeReason ( Example) |
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subjectMilestone | 0..* | BackboneElement | A significant event in the progress of a ResearchSubject
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milestone | 1..* | CodeableConcept | SignedUp | Screened | Randomized
Binding: Research Subject Milestone ( Extensible) |
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date | 0..1 | dateTime | The date/time when this milestone event was completed
|
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reason | 0..1 | CodeableConcept |
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assignedComparisonGroup | 0..1 | id | What path should be followed
|
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actualComparisonGroup | 0..1 | id | What path was followed
|
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consent | 0..* | Reference( Consent) | Agreement to participate in study
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Documentation for this format |