: Public Class
Created: 9/12/2013 4:53:00 PM
Modified: 1/12/2018 12:10:40 AM
Project:
Advanced:
DEFINITION:<br/>The completed action which marks a common administrative landmark for a subject in the course of a study.<br/><br/>EXAMPLE(S):<br/>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, assignment to a specimen collection protocol at a collection laboratory<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public TS.DATETIME
  informedConsentDate
Details:
Map:C3PR=StudySubject.informedConsentSignedDate
Map:CTOM=StudyParticipantAssignment.informedConsentFormSignedDate
Map:CTRPv3.8=PerformedSubjectMilestone.informedConsentDate
Map:CTRv1.0=PerformedStudySubjectMilestone.informedConsentDate
Map:LabViewer2.2=SubjectAssignment.informedConsentFormSignedDate
Map:LSDAMv2.2.3Plus=PerformedStudySubjectMilestone.informedConsentDate
Map:SDTM IGv3.1.3=DM.RFICDTC
Notes: DEFINITION:<br/>The date (and time) the study subject gives official consent by signing the official consent form.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Derived from PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity #gt; DefinedActivity.nameCode = "obtain informed consent".<br/>
Element Source Role Target Role
DocumentVersion
Class   		Name: usingPerformedStudySubjectMilestone
  		Name: usedDocumentVersion
 
Details:
DESCRIPTION:<br/>Each PerformedSubjectMilestone might use one DocumentVersion. Each DocumentVersion might be used for one or more PerformedSubjectMilestone.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
SpecimenCollectionProtocolSubject
Class   		Name: registeredSpecimenCollectionProtocolSubject
  		Name: registeringPerformedSubjectMilestone
 
Details:
DESCRIPTION:<br/>Each SpecimenCollectionProtocolSubject might be registered by one PerformedSubjectMilestone.  Each PerformedSubjectMilestone might register one SpecimenCollectionProtocolSubject.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>If the CollectingLaboratory is the Performer of the assignment of a Subject to a Protocol, and/or the collector of the informed consent (i.e. the performer of a PerformedSubjectMilestone), then the association from SpecimenCollectionProtocolSubject to CollectingLaboratory is redundant and should NOT be used.<br/>
Tag Value
Map:LSDAMv2.2.3Plus PerformedStudySubjectMilestone
Details:
 
Object Type Connection Direction Notes
PerformedAdministrativeActivity Class Generalization To DESCRIPTION: Each PerformedSubjectMilestone always specializes one PerformedAdministrativeActivity. Each PerformedAdministrativeActivity might be specialized by one PerformedSubjectMilestone. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PerformedStudySubjectMilestone Class Generalization From DESCRIPTION: Each PerformedStudySubjectMilestone always specializes one PerformedSubjectMilestone. Each PerformedSubjectMilestone might be specialized by one PerformedStudySubjectMilestone. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):