FHIR Release 3 (STU) R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.0.2: STU 3). (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

8.23.5 8.26.6 Resource ResearchSubject - Detailed Descriptions

Regulated Clinical Biomedical Research Information Management and Regulation Work Group Maturity Level : 0   Draft Trial Use Compartments : Patient

Detailed Descriptions for the elements in the ResearchSubject resource.

ResearchSubject
Element Id 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. A ResearchStudy involves physical entity which is the gathering primary unit of information about human or animal subjects. 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 study by the sponsor or other systems. subject for a study.

Note This is a business identifer, not a resource identifier (see discussion )
Control 0..1 0..*
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
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
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
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 )