---
type: "resource-definitions"
title: "ResearchSubject Definitions"
resource: "ResearchSubject"
---

# ResearchSubject Definitions

<a id="ResearchSubject"></a>

## 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


<a id="ResearchSubject.identifier"></a>

## ResearchSubject.identifier
Business Identifier for research subject in a study

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

**Cardinality:** 0..*

**Type:** [Identifier](/Identifier)

**Summary:** true

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


<a id="ResearchSubject.status"></a>

## ResearchSubject.status
draft | active | retired | unknown

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

**Cardinality:** 1..1

**Type:** [code](/code)

**Binding:** required:[publication-status](/valueset-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


<a id="ResearchSubject.period"></a>

## 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](/Period)

**Summary:** true

**Mappings:** BRIDG5.1=PerformedStudySubjectMilestone.studyReferenceDateRange


<a id="ResearchSubject.study"></a>

## ResearchSubject.study
Study subject is part of

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

**Cardinality:** 1..1

**Type:** Reference([ResearchStudy](/ResearchStudy))

**Summary:** true

**Mappings:** BRIDG5.1=StudySubjectProtocolVersionRelationship


<a id="ResearchSubject.subject"></a>

## 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](/Patient), [Group](/Group), [Specimen](/Specimen), [Device](/Device), [Medication](/Medication), [Substance](/Substance), [SubstanceDefinition](/SubstanceDefinition), [BiologicallyDerivedProduct](/BiologicallyDerivedProduct))

**Summary:** true

**Mappings:** BRIDG5.1=StudySubject


<a id="ResearchSubject.subjectState"></a>

## 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](/BackboneElement)


<a id="ResearchSubject.subjectState.code"></a>

## ResearchSubject.subjectState.code
candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study

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

**Cardinality:** 1..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[research-subject-state](/valueset-research-subject-state)

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


<a id="ResearchSubject.subjectState.startDate"></a>

## 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](/dateTime)


<a id="ResearchSubject.subjectState.endDate"></a>

## 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](/dateTime)


<a id="ResearchSubject.subjectState.reason"></a>

## 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](/CodeableConcept)

**Binding:** example:[state-change-reason](/valueset-state-change-reason)


<a id="ResearchSubject.subjectMilestone"></a>

## 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](/BackboneElement)


<a id="ResearchSubject.subjectMilestone.milestone"></a>

## ResearchSubject.subjectMilestone.milestone
**Definition:** A specific event in the research subject's journey through a research study.

**Cardinality:** 1..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[research-subject-milestone](/valueset-research-subject-milestone)


<a id="ResearchSubject.subjectMilestone.date"></a>

## 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](/dateTime)


<a id="ResearchSubject.subjectMilestone.reason"></a>

## ResearchSubject.subjectMilestone.reason
**Definition:** A rationale that provides additional clarification for the milestone that was captured or documented.

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[state-change-reason](/valueset-state-change-reason)


<a id="ResearchSubject.comparisonGroup"></a>

## 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](/CodeableReference)

**Binding:** example:[example-comparison-group](/valueset-example-comparison-group)

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


<a id="ResearchSubject.consent"></a>

## ResearchSubject.consent
Agreement to participate in study

**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](/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.