ResearchSubject
SpecializedA physical entity which is the primary unit of operational and/or administrative interest in a study.
| Path | Card. | Type | Description & Constraints |
|---|---|---|---|
| ResearchSubject | 0..* | — | Physical entity which is the primary unit of interest in the study |
| .idΣ | 0..1 | String | Logical id of this artifact |
| .metaΣ | 0..1 | Meta | Metadata about the resource |
| .implicitRules?!Σ | 0..1 | uri | A set of rules under which this content was created |
| .language | 0..1 | code | Language of the resource content Bindinglanguages(preferred) |
| .text | 0..1 | Narrative | Text summary of the resource, for human interpretation |
| .contained | 0..* | Resource | Contained, inline Resources |
| .extension | 0..* | Extension | Additional content defined by implementations |
| .modifierExtension?! | 0..* | Extension | Extensions that cannot be ignored |
| .identifierΣ | 0..* | Identifier | Business Identifier for research subject in a study |
| .status?!Σ | 1..1 | code | candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Bindingresearch-subject-status(required) |
| .periodΣ | 0..1 | Period | Start and end of participation |
| .studyΣ | 1..1 | Reference(ResearchStudy) | Study subject is part of |
| .individualΣ | 1..1 | Reference(Patient) | Who 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 |