PerformedSubjectMilestone

: Public Class

Created:	9/12/2013 4:53:00 PM
Modified:	3/21/2015 12:24:37 AM

Project:
Author:	wverhoef
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{AEE3EF4E-269D-437e-92DF-B0D7B7AFD258}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View BSP: Biospecimen, View SC: Study Conduct

DEFINITION: The completed action which marks a common administrative landmark for a 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, assignment to a specimen collection protocol at a collection laboratory OTHER NAME(S): NOTE(S):

Attributes
Associations To
Associations From
Tagged Values
Other Links

Attribute

Public TS.DATETIME
informedConsentDate

Details:

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

Map:C3PR=StudySubject.informedConsentSignedDate
Map:CTOM=StudyParticipantAssignment.informedConsentFormSignedDate
Map:CTRPv3.8=PerformedSubjectMilestone.informedConsentDate
Map:CTRv1.0=PerformedStudySubjectMilestone.informedConsentDate
Map:LabViewer2.2=SubjectAssignment.informedConsentFormSignedDate

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) the study subject gives 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 PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity #gt; DefinedActivity.nameCode = "obtain informed consent".#lt;br /#gt;#lt;/p#gt;

Element	Source Role	Target Role
DocumentVersion Class	Name: usingPerformedStudySubjectMilestone	Name: usedDocumentVersion
Details: DESCRIPTION:<br /></p><p>Each PerformedSubjectMilestone might use one DocumentVersion. Each DocumentVersion might be used for one or more PerformedSubjectMilestone.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>

Element	Source Role	Target Role
SpecimenCollectionProtocolSubject Class	Name: registeredSpecimenCollectionProtocolSubject	Name: registeringPerformedSubjectMilestone
Details: DESCRIPTION:<br /></p><p>Each SpecimenCollectionProtocolSubject might be registered by one PerformedSubjectMilestone. Each PerformedSubjectMilestone might register one SpecimenCollectionProtocolSubject.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>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 /></p>

Tag	Value
Map:LSDAM	PerformedStudySubjectMilestone
Details:
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):