: Public Class
Created: 10/16/2007 12:51:17 PM
Modified: 2/23/2012 4:27:54 PM
Project:
Advanced:
DEFINITION:<br /></p><p>The completed action which marks a common administrative landmark for a study subject in the course of a study.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>obtain informed consent, verify eligibility criteria, enroll, registration to a study, randomize, assignment to a treatment arm, start of on-study period, complete study visits, end of on-study period, exit study, break treatment blind, premature withdrawal<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public BL
  informedConsentIndicator
Details:
Map:HCTv1.0=CDE 2532667:Recipient Identification.Consented for Research?
Map:HCTv1.0=CDE 2630147:Recipient Identification.Consent for CIBMTR related specimen repository
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether the study subject gave official consent by signing the official consent form.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived from the existence of PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity #gt; DefinedActivity.nameCode = "obtain informed consent".#lt;br /#gt;#lt;/p#gt;
Public TS.DATETIME
  registrationDate
Details:
Map:C3PRv2.9=StudySubject.startDate
Map:caAERSv2.2=StudyParticipantAssignment.startDate
Map:CTRPv1.0=PerformedStudySubjectMilestone.registrationDate
Map:CTRPv3.8=PerformedSubjectMilestone.registrationDate
Map:CTRv1.0=PerformedStudySubjectMilestone.registrationDate
Map:LabViewer2.2=SubjectAssignment.onStudyDate
Map:LSDAM=PerformedStudySubjectMilestone.registrationDate
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) the subject has been registered to the study assuming they have finished screening and have been found eligible.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived from PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity #gt; DefinedActivity.nameCode = "register subject".#lt;br /#gt;#lt;/p#gt;
Public TS.DATETIME
  offStudyDate
Details:
Map:C3PR=StudySubject.offStudyDate
Map:C3PRv2.9=StudySubject.offStudyDate
Map:CTOM=StudyParticipantAssignment.offStudyDate
Map:CTRv1.0=PerformedStudySubjectMilestone.offStudyDate
Map:LSDAM=PerformedStudySubjectMilestone.offStudyDate
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) when the study subject is removed from the study.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The subject is not being followed and will not be retreated. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived from PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity #gt; DefinedActivity.nameCode = "remove subject from study".#lt;br /#gt;#lt;/p#gt;
Public DSET<CD>
  offStudyReasonCode
Details:
Map:C3PR=StudySubject.offStudyReasonText
Map:C3PRv2.9=StudySubject.offStudyReasonText
Map:CTOM=StudyParticipantAssignment.offStudyReasonOtherText
Map:CTOM=StudyParticipantAssignment.offStudyReasonCode
Map:CTRv1.0=PerformedStudySubjectMilestone.offStudyReasonCode
Map:LSDAM=PerformedStudySubjectMilestone.offStudyReasonCode
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying why the subject is removed from a study.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;patient died#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived from PerformedStudySubjectMilestone.reasonCode WHERE PerformedActivity #gt; DefinedActivity.nameCode = "remove subject from study".#lt;br /#gt;#lt;/p#gt;
Public IVL<TS.DATETIME>
  studyReferenceDateRange
Details:
Map:C3PR=StudySubject.startDate
Map:CTRv1.0=PerformedStudySubjectMilestone.studyReferenceDateRange
Map:LSDAM=PerformedStudySubjectMilestone.studyReferenceDateRange
Map:SDTM IGv3.1.1=DM.RFENDTC
Map:SDTM IGv3.1.1=DM.RFSTDTC
Map:SDTM IGv3.1.2=DM.RFENDTC
Map:SDTM IGv3.1.2=DM.RFSTDTC
Map:SDTM IGv3.1.2=AE.AEENTPT
Map:SDTM IGv3.1.2=MH.MHENTPT
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date and time span used to indicate the start and end of the study for a subject.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived in two parts: The start date is derived from PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity #gt; DefinedActivity.nameCode = "first intake of agent" (or other study-specific milestone). The end date is derived from PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity #gt; DefinedActivity.nameCode  = "last intake of agent" (or other study-specific milestone).#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;These dates are required for all randomized subjects; null for screen failures (if screen failures are submitted).#lt;br /#gt;#lt;/p#gt;
Tag Value
Map:C3PRv2.9 ScheduledEpoch
Details:
 
Map:CTRPv3.8 PerformedSubjectMilestone
Details:
 
Map:CTRv1.0 PerformedStudySubjectMilestone
Details:
 
Map:LabViewer2.2 SubjectAssignment
Details:
 
Map:NCI CRF Standard Enrollment
Details:
 
Map:NCI CRF Standard Registration
Details:
 
Map:SDTM IGv3.1.2 DS.DOMAIN
Details:
 
Map:SDTMIGv3.1.3 DS
Details:
 
Constraint Type Status
be participated in by Qualifier Invariant Approved
Details:
Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid.
Date Exclusive Or Invariant Approved
Details:
Only one of the date attributes will be populated in any given instance.
Object Type Connection Direction Notes
PerformedSubjectMilestone Class Generalization To DESCRIPTION: Each PerformedStudySubjectMilestone always specializes one PerformedSubjectMilestone. Each PerformedSubjectMilestone might be specialized by one PerformedStudySubjectMilestone. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):