FHIR CI-Build

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
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Biomedical Research and Regulation icon Work GroupMaturity Level: 0 Trial UseSecurity Category: Patient Compartments: Device, Patient

Detailed Descriptions for the elements in the ResearchSubject resource.

ResearchSubject
Definition

A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.

Short DisplayParticipant or object which is the recipient of investigative activities in a study
Cardinality0..*
TypeDomainResource
Alternate NamesStudy Subject
Summaryfalse
Comments

Need to make sure we encompass public health studies.

ResearchSubject.identifier
Definition

Identifiers assigned to this research subject for a study.

Short DisplayBusiness Identifier for research subject in a study
NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
ResearchSubject.status
Definition

The publication state of the resource (not of the subject).

Short Displaydraft | active | retired | unknown
Cardinality1..1
Terminology BindingPublicationStatus (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
ResearchSubject.period
Definition

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

Short DisplayStart and end of participation
Cardinality0..1
TypePeriod
Alternate Namestiming
Summarytrue
To Do.effectiveTime.
ResearchSubject.study
Definition

Reference to the study the subject is participating in.

Short DisplayStudy subject is part of
Cardinality1..1
TypeReference(ResearchStudy)
Summarytrue
ResearchSubject.subject
Definition

The record of the person, animal or other entity involved in the study.

Short DisplayWho or what is part of study
Cardinality1..1
TypeReference(Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct)
Summarytrue
ResearchSubject.subjectState
Definition

A duration in the lifecycle of the ResearchSubject within a ResearchStudy.

Short DisplayA duration in the lifecycle of the ResearchSubject within a ResearchStudy
Cardinality0..*
Summaryfalse
ResearchSubject.subjectState.code
Definition

Identifies the aspect of the subject's journey that the state refers to.

Short Displaycandidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study
Cardinality1..1
Terminology BindingResearch Subject State (Extensible)
TypeCodeableConcept
Summaryfalse
ResearchSubject.subjectState.startDate
Definition

The date a research subject entered the given state.

Short DisplayThe date a research subject entered the given state
Cardinality1..1
TypedateTime
Summaryfalse
ResearchSubject.subjectState.endDate
Definition

The date a research subject exited or left the given state.

Short DisplayThe date a research subject exited or left the given state
Cardinality0..1
TypedateTime
Summaryfalse
ResearchSubject.subjectState.reason
Definition

The reason for the state change. If coded it should follow the formal subject state model.

Short DisplayState change reason
Cardinality0..1
Terminology BindingStateChangeReason icon (Example)
TypeCodeableConcept
Summaryfalse
Comments

Example, if the milestone is "Randomized" then the reason could be "sponsor IVRS randomization code allocated".

ResearchSubject.subjectMilestone
Definition

A significant event in the progress of a ResearchSubject.

Short DisplayA significant event in the progress of a ResearchSubject
Cardinality0..*
Summaryfalse
ResearchSubject.subjectMilestone.milestone
Definition

A specific event in the research subjects journey through a research study.

Short DisplaySignedUp | Screened | Randomized
Cardinality1..*
Terminology BindingResearch Subject Milestone (Extensible)
TypeCodeableConcept
Summaryfalse
ResearchSubject.subjectMilestone.date
Definition

The date/time when this milestone event was completed.

Short DisplayThe date/time when this milestone event was completed
Cardinality0..1
TypedateTime
Summaryfalse
ResearchSubject.subjectMilestone.reason
Definition

A rationale that provides additional clarification for the milestone that was captured or documented.

Cardinality0..1
TypeCodeableConcept
Summaryfalse
ResearchSubject.assignedComparisonGroup
Definition

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

Short DisplayWhat path should be followed
Cardinality0..1
Typeid
Summaryfalse
Comments

Maybe this is really PlanDefinition.

To DoThis ought to have an identifier as well as a name OR - allocation is to a Group which is part of a planDefinition which represents an Arm.
ResearchSubject.actualComparisonGroup
Definition

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

Short DisplayWhat path was followed
Cardinality0..1
Typeid
Summaryfalse
To DoThis ought to have an identifier as well as a name OR - allocation is to a Group which is part of a planDefinition which represents an Arm.
ResearchSubject.consent
Definition

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

Short DisplayAgreement to participate in study
Cardinality0..*
TypeReference(Consent)
Summaryfalse