ResearchSubject - FHIR v1.8.0

STU3 Candidate

This page is part of the FHIR Specification (v1.8.0: STU 3 Draft). 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

8.23.4 Resource ResearchSubject - Detailed Descriptions

Detailed Descriptions for the elements in the ResearchSubject resource.

ResearchSubject
Definition	A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. ResearchStudies involve the gathering of information about human or animal subjects.
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 study by the sponsor or other systems.
Note	This is a business identifer, not a resource identifier (see discussion)
Control	0..1
Type	Identifier
Requirements	Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Summary	true
ResearchSubject.status
Definition	The current state of the event.
Control	1..1
Terminology Binding	ResearchSubjectStatus (Required)
Type	code
Is Modifier	true
Summary	true
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)