ResearchSubject - FHIR v3.2.0

R4 Draft for Comment

This page is part of the FHIR Specification (v3.2.0: R4 Ballot 1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3

8.26.6 Resource ResearchSubject - Detailed Descriptions

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Draft

Compartments: Patient

Detailed Descriptions for the elements in the ResearchSubject resource.

ResearchSubject
Definition	A physical entity which is the primary unit of operational and/or administrative interest in a study.
Control	1..1
Alternate Names	Study Subject
Comments	Need to make sure we encompass public health studies.
ResearchSubject.identifier
Definition	Identifiers assigned to this research subject for a study.
Note	This is a business identifer, not a resource identifier (see discussion)
Control	0..*
Type	Identifier
Summary	true
ResearchSubject.status
Definition	The current state of the subject.
Control	1..1
Terminology Binding	ResearchSubjectStatus (Required)
Type	code
Is Modifier	true
Summary	true
Comments	This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.
To Do	Should this be a common code system for all events?
ResearchSubject.period
Definition	The dates the subject began and ended their participation in the study.
Control	0..1
Type	Period
Alternate Names	timing
Summary	true
To Do	.effectiveTime.
ResearchSubject.study
Definition	Reference to the study the subject is participating in.
Control	1..1
Type	Reference(ResearchStudy)
Summary	true
ResearchSubject.individual
Definition	The record of the person or animal who is involved in the study.
Control	1..1
Type	Reference(Patient)
Summary	true
ResearchSubject.assignedArm
Definition	The name of the arm in the study the subject is expected to follow as part of this study.
Control	0..1
Type	string
ResearchSubject.actualArm
Definition	The name of the arm in the study the subject actually followed as part of this study.
Control	0..1
Type	string
ResearchSubject.consent
Definition	A record of the patient's informed agreement to participate in the study.
Control	0..1
Type	Reference(Consent)