: Public Class
Created: 1/28/2009 1:58:14 PM
Modified: 2/23/2012 4:29:57 PM
Project:
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DEFINITION:<br /></p><p>Describes the state of a study at a particular site as assigned by an oversight committee. <br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>request not submitted; submitted, pending; submitted, approved; submitted, exempt; submitted, denied; submission not required.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public ST.SIMPLE
  reviewBoardApprovalNumberText
Details:
Map:CTGOV=Board Approval Number
Map:CTRPv3.8=StudySite.reviewBoardApprovalNumber
Map:CTRR=IRB Approval Number
Map:CTRv1.0=StudySiteOversightStatus.reviewBoardApprovalNumberText
Map:HCTv1.0=MD Anderson Specific Content: Protocol .NIH-OBA Number
Map:HCTv1.0=MD Anderson Specific Content: Protocol .IBC number
Map:HCTv1.0=MD Anderson Specific Content: Protocol .IRB number
Map:HSDBv1.0=[IRB].IRB number
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A character string that is assigned by the review board upon approval of the protocol.#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;12-001234, 4-05, or any string defined by the review board.#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;
Public CD
  reviewBoardProcessCode
Details:
Map:CTGOV=Board Approval Status
Map:CTRPv3.8=StudySite.reviewBoardApprovalStatusCode
Map:CTRR=IRB Review/Approval Status
Map:CTRv1.0=StudySiteOversightStatus.reviewBoardProcessCode
Map:HSDBv1.0=[IRB].IRB review type
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the phase in the lifecycle of the review board process.#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;request not submitted; submitted, pending; submitted, approved; submitted, exempt; submitted, denied; submission not required#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;Please refer to the Review Board Process Status state transition diagram for further details.#lt;br /#gt;#lt;/p#gt;
Public TS.DATETIME
  reviewBoardProcessDate
Details:
Map:C3PR=StudySite.irbApprovalDate
Map:C3PRv2.9=StudySiteStudyVersion.irbApprovalDate
Map:CTOM=StudySite.irbApprovalDate
Map:CTRv1.0=StudySiteOversightStatus.reviewBoardProcessDate
Map:HSDBv1.0=[IRB].IRB approval date
Map:PSCv2.6=AmendmentApproval.date
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) on which the Institutional Review Board (IRB) determined the status of this study protocol for execution at this site.#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;Review Board Approval Date#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: 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>
OversightCommittee
Class   		Name: assignedStudySiteOversightStatus
  		Name: assigningOversightCommittee
 
Details:
DESCRIPTION:<br /></p><p>Each StudySiteOversightStatus might be assigned by one OversightCommittee.  Each OversightCommittee might assign 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:CTRv1.0 StudySiteOversightStatus
Details:
 
Map:PSCv2.6 AmendmentApproval
Details:
 
Constraint Type Status
be assigned by actualIndicator Qualifier Invariant Approved
Details:
Only Organization (via OversightCommittee) with actualIndicator = "true" is valid.