| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 | ||
| Σ | 0..* | Identifier | Business Identifier for research subject in a study | |
| ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (Required) | |
| 0..* | BackboneElement | Subject status | ||
| 0..1 | CodeableConcept | state | milestone Binding: Research Subject State Type (Example) | ||
| 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| on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: Research Subject State (Required) | ||
| 0..1 | CodeableConcept | SignedUp | Screened | Randomized Binding: Research Subject Milestone (Example) | ||
| 0..1 | CodeableConcept | State change reason Binding: StateChangeReason (Example) | ||
| 0..1 | dateTime | State change date | ||
| 0..1 | dateTime | State change date | ||
| Σ | 0..1 | Period | Start and end of participation | |
| Σ | 1..1 | Reference(ResearchStudy) | Study subject is part of | |
| Σ | 1..1 | Reference(Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct) | Who or what is part of study | |
| 0..1 | id | What path should be followed | ||
| 0..1 | id | What path was followed | ||
| 0..* | Reference(Consent) | Agreement to participate in study | ||