Release 4 4B

This page is part of the FHIR Specification (v4.0.1: R4 (v4.3.0: R4B - Mixed Normative and STU ) in it's permanent home (it will always be available at this URL). ). 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 R4B R4 R3

8.23.6 8.23.7 Resource ResearchSubject - Detailed Descriptions

Biomedical Research and Regulation Work Group Maturity Level : 1 0   Trial Use Security Category : Patient 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.

Cardinality 0..*
Type DomainResource
Alternate Names Study Subject
Summary false
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 identifier, not a resource identifier (see discussion )
Cardinality 0..*
Type Identifier
Summary true
ResearchSubject.status
Element Id ResearchSubject.status
Definition

The current state of the subject.

Cardinality 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.

Cardinality 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.

Cardinality 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.

Cardinality 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.

Cardinality 0..1
Type string
Summary false
ResearchSubject.actualArm
Element Id ResearchSubject.actualArm
Definition

The name of the arm in the study the subject actually followed as part of this study.

Cardinality 0..1
Type string
Summary false
ResearchSubject.consent
Element Id ResearchSubject.consent
Definition

A record of the patient's informed agreement to participate in the study.

Cardinality 0..1
Type Reference ( Consent )
Summary false