type: resource-definitionsresource: ResearchSubject

ResearchSubject Definitions

ResearchSubject

Participant or object which is the recipient of investigative activities in a study

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

Comments: Need to make sure we encompass public health studies.

Aliases: Study Subject

Cardinality: 0..*

Mappings: BRIDG5.1=StudySubject; v2=OBX; rim=Observation[classCode=CLNTRL, moodCode=EVN]; w5=clinical.diagnostics

ResearchSubject.identifier

Business Identifier for research subject in a study

Definition: Identifiers assigned to this research subject for a study.

Cardinality: 0..*

Type: Identifier

Summary: true

Mappings: w5=FiveWs.identifier; BRIDG5.1=StudySubject > Subject.identifier; rim=.identifier

ResearchSubject.status

draft | active | retired | unknown

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

Cardinality: 1..1

Type: code

Binding: required:publication-status

Summary: true

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)

Mappings: w5=FiveWs.status; BRIDG5.1=StudySubject.statusCode; rim=.status

ResearchSubject.period

Start and end of participation

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

Aliases: timing

Cardinality: 0..1

Type: Period

Summary: true

Mappings: BRIDG5.1=PerformedStudySubjectMilestone.studyReferenceDateRange

ResearchSubject.study

Study subject is part of

Definition: Reference to the study the subject is participating in.

Cardinality: 1..1

Type: Reference(ResearchStudy)

Summary: true

Mappings: BRIDG5.1=StudySubjectProtocolVersionRelationship

ResearchSubject.subject

Who or what is part of study

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

Cardinality: 1..1

Type: Reference(Patient, Group, Specimen, Device, Medication, Substance, SubstanceDefinition, BiologicallyDerivedProduct)

Summary: true

Mappings: BRIDG5.1=StudySubject

ResearchSubject.subjectState

A duration in the lifecycle of the ResearchSubject within a ResearchStudy

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

Cardinality: 0..*

Type: BackboneElement

ResearchSubject.subjectState.code

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

Cardinality: 1..1

Type: CodeableConcept

Binding: example:research-subject-state

Mappings: w5=FiveWs.status; BRIDG5.1=StudySubject.statusCode; rim=.status

ResearchSubject.subjectState.startDate

The date a research subject entered the given state

Definition: The date a research subject entered the given state.

Cardinality: 1..1

Type: dateTime

ResearchSubject.subjectState.endDate

The date a research subject exited or left the given state

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

Cardinality: 0..1

Type: dateTime

ResearchSubject.subjectState.reason

State change reason

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

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

Cardinality: 0..1

Type: CodeableConcept

Binding: example:state-change-reason

ResearchSubject.subjectMilestone

A significant event in the progress of a ResearchSubject

Definition: A significant event in the progress of a ResearchSubject.

Cardinality: 0..*

Type: BackboneElement

ResearchSubject.subjectMilestone.milestone

Definition: A specific event in the research subject's journey through a research study.

Cardinality: 1..1

Type: CodeableConcept

Binding: example:research-subject-milestone

ResearchSubject.subjectMilestone.date

The date/time when this milestone event was completed

Definition: The date/time when this milestone event was completed.

Cardinality: 0..1

Type: dateTime

ResearchSubject.subjectMilestone.reason

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

Cardinality: 0..*

Type: CodeableConcept

Binding: example:state-change-reason

ResearchSubject.comparisonGroup

A group to which the subject is assigned

Definition: A group to which the subject is assigned. This group assignment is used for administration or analysis.

Comments: This grouping is used for study administration (such as assignment to arms in a trial) or study analysis (such as groupings for observational studies or sensitivity analyses).

Cardinality: 0..*

Type: CodeableReference

Binding: example:example-comparison-group

Mappings: BRIDG5.1=Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject

Definition: Agreement to participate in a study as well as other research agreements, e.g. to acknowledge additional risks, to agree to a protocol deviation, or to agree to more invasive validation subsidies.

Cardinality: 0..*

Type: Reference(Consent)

Mappings: BRIDG5.1=ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource.