Study Conduct Sub-Domain::StudySiteProtocolVersionRelationship

: Public Class

Created:	5/21/2010 3:42:25 PM
Modified:	8/26/2017 2:57:24 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{2670772D-9B2D-46dc-A477-59584872DE31}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View PR: Protocol Representation, Study Versioning View, View SC: Study Conduct, View IM: Imaging, StudySite and StudySubject, Oncology & Imaging View, ClinicalTrials.gov, Participant Registration

DEFINITION: Specifies the link between a study site and a version of the study protocol used or available for use at that site. EXAMPLE(S): OTHER NAME(S): NOTE(S): Even if a study site's IRB has not reviewed the study protocol version, if there is a new version for the study protocol, then there is the potential for a relationship between the site and the version. The dateRange is specified only if the version is approved for this site by the IRB and activated at the site. Retroactive approval means that the dateRange does not have to be on or after the IRB approval date.

Attributes
Associations To
Associations From
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=StudySiteStudyVersion.startDate
Map:C3PRv2.9=StudySiteStudyVersion.endDate
Map:CTRv1.0=StudySiteProtocolVersionRelationship.effectiveDateRange

Notes:

DEFINITION: The date and time span specifying when the relationship between a study site and study protocol version begins and ends. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
StudySite Class	Name: executedStudySiteProtocolVersionRelationship	Name: executingStudySite
Details: DESCRIPTION:<br/>Each StudySiteProtocolVersionRelationship always is executed at one StudySite. Each StudySite might execute one or more StudySiteProtocolVersionRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudyProtocolVersion Class	Name: executingStudySiteProtocolVersionRelationship	Name: executedStudyProtocolVersion
Details: DESCRIPTION:<br/>Each StudySiteProtocolVersionRelationship always executes one StudyProtocolVersion. Each StudyProtocolVersion might be executed at one or more StudySiteProtocolVersionRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Element	Source Role	Target Role
StudySubjectProtocolVersionRelationship Class	Name: assignedStudySubjectProtocolVersionRelationship	Name: assigningStudySiteProtocolVersionRelationship
Details: DESCRIPTION:<br/>Each StudySubjectProtocolVersionRelationship always is assigned to one StudySiteProtocolVersionRelationship. Each StudySiteProtocolVersionRelationship might be the assigned version for one or more StudySubjectProtocolVersionRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudySiteOversightStatus Class	Name: describingStudySiteOversightStatus	Name: describedStudySiteProtocolVersionRelationship
Details: DESCRIPTION:<br/>Each StudySiteOversightStatus always describes one StudySiteProtocolVersionRelationship. Each StudySiteProtocolVersionRelationship might be described by one or more StudySiteOversightStatus.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:C3PRv2.9	StudySiteStudyVersion
Details:
Map:CTRv1.0	StudySiteProtocolVersionRelationship
Details: