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Biomedical Research and Regulation Work GroupMaturity Level: 0 Trial UseSecurity Category: Patient Compartments: Patient

Detailed Descriptions for the elements in the ResearchSubject resource.

ResearchSubject
Element IdResearchSubject
Definition

A physical entity which is the primary unit of operational and/or administrative interest in a study.

Cardinality0..*
TypeDomainResource
Alternate NamesStudy Subject
Comments

Need to make sure we encompass public health studies.

ResearchSubject.identifier
Element IdResearchSubject.identifier
Definition

Identifiers assigned to this research subject for a study.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
ResearchSubject.status
Element IdResearchSubject.status
Definition

The current state of the subject.

Cardinality1..1
Terminology BindingResearchSubjectStatus (Required)
Typecode
Is Modifiertrue (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)
Summarytrue
To DoShould this be a common code system for all events?
ResearchSubject.period
Element IdResearchSubject.period
Definition

The dates the subject began and ended their participation in the study.

Cardinality0..1
TypePeriod
Alternate Namestiming
Summarytrue
To Do.effectiveTime.
ResearchSubject.study
Element IdResearchSubject.study
Definition

Reference to the study the subject is participating in.

Cardinality1..1
TypeReference(ResearchStudy)
Summarytrue
ResearchSubject.individual
Element IdResearchSubject.individual
Definition

The record of the person or animal who is involved in the study.

Cardinality1..1
TypeReference(Patient)
Summarytrue
ResearchSubject.assignedArm
Element IdResearchSubject.assignedArm
Definition

The name of the arm in the study the subject is expected to follow as part of this study.

Cardinality0..1
Typestring
ResearchSubject.actualArm
Element IdResearchSubject.actualArm
Definition

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

Cardinality0..1
Typestring
ResearchSubject.consent
Element IdResearchSubject.consent
Definition

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

Cardinality0..1
TypeReference(Consent)