ResearchSubject - FHIR v3.5.0

R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). 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

Trial Use

Compartments: Patient

Detailed Descriptions for the elements in the ResearchSubject resource.

ResearchSubject
Element Id	ResearchSubject
Definition	A physical entity which is the primary unit of operational and/or administrative interest in a study.
Control	1..1
Type	DomainResource
Alternate Names	Study Subject
Comments	Need to make sure we encompass public health studies.
ResearchSubject.identifier
Element Id	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
Element Id	ResearchSubject.status
Definition	The current state of the subject.
Control	1..1
Terminology Binding	ResearchSubjectStatus (Required)
Type	code
Is Modifier	true (Reason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid)
Summary	true
To Do	Should this be a common code system for all events?
ResearchSubject.period
Element Id	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
Element Id	ResearchSubject.study
Definition	Reference to the study the subject is participating in.
Control	1..1
Type	Reference(ResearchStudy)
Summary	true
ResearchSubject.individual
Element Id	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
Element Id	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
Element Id	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
Element Id	ResearchSubject.consent
Definition	A record of the patient's informed agreement to participate in the study.
Control	0..1
Type	Reference(Consent)