: Public Class
Created: 5/21/2010 3:42:25 PM
Modified: 2/23/2012 4:30:08 PM
Project:
Advanced:
DEFINITION:<br /></p><p>Specifies the link between a study site and a version of the study protocol used or available for use at that site. <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>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.<br /></p>
Attribute
Public IVL<TS.DATETIME>
  effectiveDateRange
Details:
Map:C3PRv2.9=StudySiteStudyVersion.startDate
Map:C3PRv2.9=StudySiteStudyVersion.endDate
Map:CTRv1.0=StudySiteProtocolVersionRelationship.effectiveDateRange
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date and time span specifying when the relationship between a study site 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
StudySite
Class   		Name: executedStudySiteProtocolVersionRelationship
  		Name: executingStudySite
 
Details:
DESCRIPTION:<br /></p><p>Each StudySiteProtocolVersionRelationship always is executed at one StudySite. Each StudySite might execute one or more StudySiteProtocolVersionRelationship.<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>
StudyProtocolVersion
Class   		Name: executingStudySiteProtocolVersionRelationship
  		Name: executedStudyProtocolVersion
 
Details:
DESCRIPTION:<br /></p><p>Each StudySiteProtocolVersionRelationship always executes one StudyProtocolVersion. Each StudyProtocolVersion might be executed at one or more StudySiteProtocolVersionRelationship.<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
StudySubjectProtocolVersionRelationship
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>
StudySiteOversightStatus
Class   		Name: describingStudySiteOversightStatus
  		Name: describedStudySiteProtocolVersionRelationship
 
Details:
DESCRIPTION:<br /></p><p>Each StudySiteOversightStatus always describes one StudySiteProtocolVersionRelationship. Each StudySiteProtocolVersionRelationship might be described by one or more StudySiteOversightStatus.<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 StudySiteStudyVersion
Details:
 
Map:CTRv1.0 StudySiteProtocolVersionRelationship
Details: