: Public Class
Created: 12/14/2005 11:24:06 AM
Modified: 8/30/2019 11:09:33 PM
Project:
Advanced:
DEFINITION:<br/>A physical entity which is the primary unit of operational and/or administrative interest in a study. <br/><br/>EXAMPLE(S):<br/>A person who is registered in a study as a recipient of an investigational product or as a control. <br/><br/>Individuals who are being screened for studies.<br/><br/>Individuals participating in observational or other studies.  <br/><br/>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.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>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.<br/>
Attribute
Public BL
  confidentialityIndicator
Details:
Map:CTOM=Participant.confidentialityIndicator
Map:CTRv1.0=StudySubject.confidentialityIndicator
Notes: DEFINITION:<br/>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).<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  statusCode
Details:
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
Map:SDTM IGv3.2=DM.ACTARMCD
Map:SDTM IGv3.2=DM.ACTARM
Notes: DEFINITION:<br/>A coded value specifying the phase in the lifecycle of the study subject.<br/><br/>EXAMPLE(S):<br/>candidate, eligible, follow-up, ineligible, not registered, off-study, on-study, pending on-study, potential candidate, screening, withdrawn<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Please refer to the Study Subject Status state transition diagram for further details. <br/><br/>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. <br/><br/>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.<br/><br/>
Public TS.DATETIME
  statusDate
Details:
Map:C3PR=StudyPersonnel.startDate
Map:C3PR=StudyPersonnel.endDate
Map:C3PR=StudySubject.statusDateRange
Map:CTRPv3.8=FunctionalRole.statusDateRange
Map:CTRv1.0=StudySubject.statusDate
Notes: DEFINITION:<br/>The date (and time) on which the status is assigned to the study subject.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
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/>
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/>
Tag Value
Map:C3PRv2.9 StudySubject
Details:
 
Map:CTRPv3.8 StudySite.(StudySubject)
Details:
 
Map:CTRPv3.8 StudySubject
Details:
 
Map:CTRPv3.8 Patient.(StudySubject)
Details:
 
Map:CTRv1.0 StudySubject
Details:
 
Map:DICOM Clinical Trial Subject Module
Details:
 
Map:DICOM Clinical Trial Context Module
Details:
 
Map:HL7SP Study.subject
Details:
 
Map:ICSRr2 Subject (in IndividualCaseSafetyReport)
Details:
 
Map:NBIAv6.4 Clinical_Trial_Subject
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:
 
Map:SDTM IGv3.2 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):