StudySubjectProtocolVersionRelationship

: Public Class

Created:	5/21/2010 3:50:05 PM
Modified:	2/23/2012 4:30:33 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{4E263634-3D33-4e02-86F6-4A4EB8BF85FE}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View PR: Protocol Representation, Study Versioning View, View SC: Study Conduct

DEFINITION: Specifies the link between a study subject and a version of the study protocol at a site. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Attributes
Associations To
Tagged Values

Attribute

Public IVL<TS.DATETIME>
effectiveDateRange

Details:

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

Map:C3PRv2.9=StudySubjectStudyVersion
Map:CTRv1.0=StudySubjectProtocolVersionRelationship.effectiveDateRange

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date and time span specifying when the relationship between a study subject and study protocol version begins and ends.#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;

Element	Source Role	Target Role
StudySiteProtocolVersionRelationship Class	Name: assignedStudySubjectProtocolVersionRelationship	Name: assigningStudySiteProtocolVersionRelationship
Details: DESCRIPTION:<br /></p><p>Each StudySubjectProtocolVersionRelationship always is assigned to one StudySiteProtocolVersionRelationship. Each StudySiteProtocolVersionRelationship might be the assigned version for one or more StudySubjectProtocolVersionRelationship.<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>
StudySubject Class	Name: assignedStudySubjectProtocolVersionRelationship	Name: assigningStudySubject
Details: DESCRIPTION:<br /></p><p>Each StudySubjectProtocolVersionRelationship always is the assigned version for one StudySubject. Each StudySubject might be assigned to one or more StudySubjectProtocolVersionRelationship.<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>

Tag	Value
Map:C3PRv2.9	StudySubjectStudyVersion
Details:
Map:caAERSv2.2	StudyParticipantAssignment
Details:
Map:CTRv1.0	StudySubjectProtocolVersionRelationship
Details:
Map:ICSRr2	Subject12 (in IndividualCaseSafetyReport)
Details: