| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
ResearchSubject
|
TU | DomainResource | Physical entity which is the primary unit of interest in the 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
|
status
|
?! Σ | 1..1 | code | draft | active | retired | unknown
PublicationStatus ( Required) |
progress
|
0..* | BackboneElement | Subject status
|
|
type
|
0..1 | CodeableConcept | state | milestone
ResearchSubjectStateType ( Example) |
|
|
subjectState
|
0..1 | CodeableConcept | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
ResearchSubjectState ( Required) |
|
|
milestone
|
0..1 | CodeableConcept | SignedUp | Screened | Randomized
ResearchSubjectMilestone ( Example) |
|
|
reason
|
0..1 | CodeableConcept | State change reason
StateChangeReason ( Example) |
|
|
startDate
|
0..1 | dateTime | State change date
|
|
endDate
|
0..1 | dateTime | State change date
|
|
|
period
|
Σ | 0..1 | Period | Start and end of participation
|
study
|
Σ | 1..1 | Reference( ResearchStudy) | Study subject is part of
|
|
subject
|
Σ | 1..1 | Reference( Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct) | Who or what is part of study
|
|
assignedArm
|
0..1 | string | What path should be followed
|
|
|
actualArm
|
0..1 | string | What path was followed
|
|
|
consent
|
0..1 | Reference( Consent) | Agreement to participate in study
|
|
|
Documentation for this format
|
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