: Public Class
Created: 1/28/2009 1:58:14 PM
Modified: 8/26/2017 2:57:23 AM
Project:
Advanced:
DEFINITION:<br/>Describes the state of a study at a particular site as assigned by an oversight committee. <br/><br/>EXAMPLE(S):<br/>request not submitted; submitted, pending; submitted, approved; submitted, exempt; submitted, denied; submission not required.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
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:DICOM=Clinical Trial Subject Module - Clinical Trial Protocol Ethics Committee Approval Number (0012,0082)
Map:DICOM=Clinical Trial Context Module - Clinical Trial Protocol Ethics Committee Approval Number (0012,0082)
Map:HCTv1.0=MD Anderson Specific Content: Protocol .IBC number
Map:HCTv1.0=MD Anderson Specific Content: Protocol .IRB number
Map:HCTv1.0=MD Anderson Specific Content: Protocol .NIH-OBA Number
Map:HSDBv1.0=[IRB].IRB number
Notes: DEFINITION:<br/>A character string that is assigned by the review board upon approval of the protocol.<br/><br/>EXAMPLE(S):<br/>12-001234, 4-05, or any string defined by the review board.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
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:<br/>A coded value specifying the phase in the lifecycle of the review board process.<br/><br/>EXAMPLE(S):<br/>request not submitted; submitted, pending; submitted, approved; submitted, exempt; submitted, denied; submission not required<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Please refer to the Review Board Process Status state transition diagram for further details.<br/>
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:<br/>The date (and time) on which the Institutional Review Board (IRB) determined the status of this study protocol for execution at this site.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/>Review Board Approval Date<br/><br/>NOTE(S):<br/>
Public IVL<TS.DATETIME>
  effectiveDateRange
Details:
Map:DICOM=Clinical Trial Context Module - Ethics Committee Approval Effectiveness End Date (0012,0087)
Map:DICOM=Clinical Trial Context Module - Ethics Committee Approval Effectiveness Start Date (0012,0086)
Notes: DEFINITION:<br/>The date and time span specifying when the review board's oversight status (process code) begins and ends.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/>Ethics Committee Approval Effectiveness Start and End Date<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
StudySiteProtocolVersionRelationship
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/>
OversightCommittee
Class  
Name: assignedStudySiteOversightStatus
 
Name: assigningOversightCommittee
 
Details:
DESCRIPTION:<br/>Each StudySiteOversightStatus might be assigned by one OversightCommittee.  Each OversightCommittee might assign 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: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.<br/>