Common Sub-Domain::StudySubject

: Public Class

Created:	12/14/2005 11:24:06 AM
Modified:	8/26/2017 2:00:49 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{3AA85975-658A-4206-835C-3AD4279FB993}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View AE: Adverse Event, View CM: Common, View PR: Protocol Representation, Study Versioning View, View SC: Study Conduct, View IM: Imaging, Subject and ExperimentalUnit Comparison, StudySite and StudySubject, Oncology & Imaging View, Oncology View, SDTM 3.1.3 View, SDTM Vital Signs (VS) View, SDTM Disease Response (RS) Domain View, SDTM Exposure (EX) Domain View, Participant Registration

DEFINITION: A physical entity which is the primary unit of operational and/or administrative interest in a study. EXAMPLE(S): A person who is registered in a study as a recipient of an investigational product or as a control. Individuals who are being screened for studies. Individuals participating in observational or other studies. A pacemaker, a fuse that can be used in medical devices, a cow, a pen of pigs, or a tissue sample from a tissue bank. OTHER NAME(S): NOTE(S): StudySubjects within a study are all of the same type. An entity registered in a study is not part of another entity registered in the same study.

Attributes
Associations From
Tagged Values
Constraints
Other Links

Attribute

Public BL
confidentialityIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTOM=Participant.confidentialityIndicator
Map:CTRv1.0=StudySubject.confidentialityIndicator

Notes:

DEFINITION: Specifies whether the study subject, or their legally acceptable representative, has not authorized the use and disclosure of their protected health information (i.e., the study subject's data is private and confidential). EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public CD
statusCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:C3PR=StudySubject.status
Map:C3PR=StudySubject.state
Map:C3PRv2.9=StudySubject.regWorkflowStatus
Map:CTRPv3.8=FunctionalRole.statusCode
Map:CTRv1.0=StudySubject.statusCode
Map:SDTM IGv3.1.3=DM.ACTARMCD
Map:SDTM IGv3.1.3=DM.ACTARM

Notes:

DEFINITION: A coded value specifying the phase in the lifecycle of the study subject. EXAMPLE(S): candidate, eligible, follow-up, ineligible, not registered, off-study, on-study, pending on-study, potential candidate, screening, withdrawn OTHER NAME(S): NOTE(S): Please refer to the Study Subject Status state transition diagram for further details. If in CDISC’s SDTM DM.ACTARMCD = "NOTRT“ (meaning "Not Treated"), this is a subject who passed eligibility, was assigned a treatment but never started, e.g. withdrew before treatment started, etc., so a PerformedExperimentalUnitAllocation exists for this subject. If in CDISC’s SDTM DM.ACTARMCD = "NOTASSGN" (meaning "Not Assigned"), this is a case where DMARM = DMACTARM, meaning after eligibility was determined, the subject may be left over/unneeded, or withdraws, or doesn’t pass further eligibility criteria, or is in a wait period between eligibility/intake and assignment – all are possible statusCode values. And all those values could be fine grained statuses in a BRIDG-based system that each roll up into “NOT ASSIGNED” to be reported in SDTM data sets. In this case PerformedExperimentalUnitAllocation doesn’t exist.

Public TS.DATETIME
statusDate

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:C3PR=StudyPersonnel.startDate
Map:C3PR=StudyPersonnel.endDate
Map:C3PR=StudySubject.statusDateRange
Map:CTRPv3.8=FunctionalRole.statusDateRange
Map:CTRv1.0=StudySubject.statusDate

Notes:

DEFINITION: The date (and time) on which the status is assigned to the study subject. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
StudySubjectProtocolVersionRelationship Class	Name: assignedStudySubjectProtocolVersionRelationship	Name: assigningStudySubject
Details: DESCRIPTION:<br/>Each StudySubjectProtocolVersionRelationship always is the assigned version for one StudySubject. Each StudySubject might be assigned to one or more StudySubjectProtocolVersionRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudySubjectExperienceDocumentVersion Class	Name: describingStudySubjectExperienceDocumentVersion	Name: describedStudySubject
Details: DESCRIPTION:<br/>Each StudySubjectExperienceDocumentVersion always describes experience of one StudySubject. Each StudySubject might have experience described by one or more StudySubjectExperienceDocumentVersion.<br/><br/>DEFINITION:<br/>Indicates the subject whose experience is recounted in the study subject experience document.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>

Tag	Value
Map:C3PRv2.9	StudySubject
Details:
Map:CTRPv3.8	Patient.(StudySubject)
Details:
Map:CTRPv3.8	StudySite.(StudySubject)
Details:
Map:CTRPv3.8	StudySubject
Details:
Map:CTRv1.0	StudySubject
Details:
Map:DICOM	Clinical Trial Context Module
Details:
Map:DICOM	Clinical Trial Subject Module
Details:
Map:HL7SP	Study.subject
Details:
Map:ICSRr2	Subject (in IndividualCaseSafetyReport)
Details:
Map:NCI CRF Standard	ParticipantIdentifier
Details:
Map:PSCv2.6	Subject
Details:
Map:PSCv2.6	StudySubjectAssignment
Details:
Map:SDTM IGv3.1.2	DM.DOMAIN
Details:
Map:SDTM IGv3.1.3	DM
Details:

Constraint	Type	Status
be a function performed by Not Applicable	Invariant	Approved
Details: Association from Organization is not valid.<br/>

Object	Type	Connection	Direction	Notes
Subject	Class	Generalization	To	DESCRIPTION: Each StudySubject always specializes one Subject. Each Subject might be specialized by one StudySubject. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):