http://hl7.org/fhir/StructureDefinition/ResearchSubject|5.0.0

A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.
NameFlagsCardTypeDescription & Constraints
ResearchSubject
0..*Participant or object which is the recipient of investigative activities in a study
 
identifier
Σ
0..*IdentifierBusiness Identifier for research subject in a study
 
status *
?!Σ
1..1codedraft | active | retired | unknown PublicationStatus (required)
 
progress
0..*BackboneElementSubject status
 
 
type
0..1CodeableConceptstate | milestone ResearchSubjectStateType (example)
 
 
subjectState
0..1CodeableConceptcandidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn ResearchSubjectProgresss (required)
 
 
milestone
0..1CodeableConceptSignedUp | Screened | Randomized ResearchSubjectMilestone (example)
 
 
reason
0..1CodeableConceptState change reason StateChangeReason (example)
 
 
startDate
0..1dateTimeState change date
 
 
endDate
0..1dateTimeState change date
 
period
Σ
0..1PeriodStart and end of participation
 
study *
Σ
1..1ReferenceStudy subject is part of
 
subject *
Σ
1..1ReferenceWho or what is part of study
 
assignedComparisonGroup
0..1idWhat path should be followed
 
actualComparisonGroup
0..1idWhat path was followed
 
consent
0..*ReferenceAgreement to participate in study