Study Conduct Sub-Domain::PerformedStudySubjectMilestone

: Public Class

Created:	10/16/2007 12:51:17 PM
Modified:	1/12/2018 12:10:40 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{65204653-409B-45d3-8FAD-869E5912444C}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View SC: Study Conduct, SDTM 3.1.3 View, Participant Registration, Lab-Related Classes

DEFINITION: The completed action which marks a common administrative landmark for a study subject in the course of a study. EXAMPLE(S): 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 OTHER NAME(S): NOTE(S):

Attributes
Tagged Values
Constraints
Other Links

Attribute

Public BL
informedConsentIndicator

Details:

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

Map:HCTv1.0=CDE 2630147:Recipient Identification.Consent for CIBMTR related specimen repository
Map:HCTv1.0=CDE 2532667:Recipient Identification.Consented for Research?

Notes:

DEFINITION: Specifies whether the study subject gave official consent by signing the official consent form. EXAMPLE(S): OTHER NAME(S): NOTE(S): Derived from the existence of PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity #gt; DefinedActivity.nameCode = "obtain informed consent".

Public TS.DATETIME
registrationDate

Details:

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

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:LSDAMv2.2.3Plus=PerformedStudySubjectMilestone.registrationDate

Notes:

DEFINITION: The date (and time) the subject has been registered to the study assuming they have finished screening and have been found eligible. EXAMPLE(S): OTHER NAME(S): NOTE(S): Derived from PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity #gt; DefinedActivity.nameCode = "register subject".

Public TS.DATETIME
offStudyDate

Details:

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

Map:C3PR=StudySubject.offStudyDate
Map:C3PRv2.9=StudySubject.offStudyDate
Map:CTOM=StudyParticipantAssignment.offStudyDate
Map:CTRv1.0=PerformedStudySubjectMilestone.offStudyDate
Map:LSDAMv2.2.3Plus=PerformedStudySubjectMilestone.offStudyDate

Notes:

DEFINITION: The date (and time) when the study subject is removed from the study. EXAMPLE(S): The subject is not being followed and will not be retreated. OTHER NAME(S): NOTE(S): Derived from PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity #gt; DefinedActivity.nameCode = "remove subject from study".

Public DSET<CD>
offStudyReasonCode

Details:

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

Map:C3PR=StudySubject.offStudyReasonText
Map:C3PRv2.9=StudySubject.offStudyReasonText
Map:CTOM=StudyParticipantAssignment.offStudyReasonCode
Map:CTOM=StudyParticipantAssignment.offStudyReasonOtherText
Map:CTRv1.0=PerformedStudySubjectMilestone.offStudyReasonCode
Map:LSDAMv2.2.3Plus=PerformedStudySubjectMilestone.offStudyReasonCode

Notes:

DEFINITION: A coded value specifying why the subject is removed from a study. EXAMPLE(S): patient died OTHER NAME(S): NOTE(S): Derived from PerformedStudySubjectMilestone.reasonCode WHERE PerformedActivity #gt; DefinedActivity.nameCode = "remove subject from study".

Public IVL<TS.DATETIME>
studyReferenceDateRange

Details:

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

Map:C3PR=StudySubject.startDate
Map:CTRv1.0=PerformedStudySubjectMilestone.studyReferenceDateRange
Map:LSDAMv2.2.3Plus=PerformedStudySubjectMilestone.studyReferenceDateRange
Map:SDTM IGv3.1.1=DM.RFSTDTC
Map:SDTM IGv3.1.1=DM.RFENDTC
Map:SDTM IGv3.1.2=DM.RFENDTC
Map:SDTM IGv3.1.2=DM.RFSTDTC
Map:SDTM IGv3.1.2=MH.MHENTPT
Map:SDTM IGv3.1.2=AE.AEENTPT
Map:SDTM IGv3.1.3=DM.RFSTDTC
Map:SDTM IGv3.1.3=DM.RFENDTC

Notes:

DEFINITION: The date and time span used to indicate the start and end of the study for a subject. EXAMPLE(S): OTHER NAME(S): NOTE(S): 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). These dates are required for all randomized subjects; null for screen failures (if screen failures are submitted).

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:SDTM IGv3.1.3	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.<br/>
Date Exclusive Or	Invariant	Approved
Details: Only one of the date attributes will be populated in any given instance.<br/>

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):