: Public Class
Created: 5/15/2008 12:06:22 PM
Modified: 3/17/2015 12:16:25 AM
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DEFINITION:<br /></p><p>Describes the comprehensive state of the study.<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>The actual overall status of a study may be derived if it is possible to roll-up the site-specific status.<br /></p>
Attribute
Public CD
  code
Details:
Map:C3PRv2.9=Study.coordinatingCenterStudyStatus
Map:caAERSv2.2=Study.status
Map:CTRPv1.0=StudyOverallStatus.statusCode
Map:CTRPv3.8=StudyOverallStatus.statusCode
Map:CTRR=Trial Status
Map:CTRRr3=StudyOverallStatus.statusCode
Map:CTRv1.0=StudyOverallStatus.code
Map:HSDBv1.0=[Study status] .Current Trial Status
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the phase in the lifecycle of the study as a whole.#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;In Review, Approved, Active, Closed to Accrual, Closed to Accrual and Intervention, Temporary Closed to Accrual, Temporary Closed to Accrual and Intervention, Disapproved, Withdrawn, Administratively complete.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br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 Study Overall Status state transition diagram for further details.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The overall status of a study may overlap with the study site status and accrual status. This overlap needs to be clearly differentiated. (See tracker issue 29398). A proposed solution is to eliminate the study recruitmentl status codes and adopt the CTRP values for study status code.#lt;br /#gt;#lt;/p#gt;
Public TS.DATETIME
  date
Details:
Map:CTGOV=Study Start Date
Map:CTGOV=Actual Study Completion Date
Map:CTGOV=Anticipated Study Completion Date
Map:CTGOV=Actual Primary Completion Date
Map:CTGOV=Anticipated Primary Completion Date
Map:CTRPv1.0=InterventionalStudyProtocol.primaryCompletionDate
Map:CTRPv1.0=StudyOverallStatus.statusDate
Map:CTRPv1.0=ObservationalStudyProtocol.startDate
Map:CTRPv1.0=ObservationalStudyProtocol.primaryCompletionDate
Map:CTRPv1.0=StudyProtocol.primaryCompletionDate
Map:CTRPv1.0=InterventionalStudyProtocol.statusDate
Map:CTRPv1.0=StudyProtocol.startDate
Map:CTRPv3.8=StudyProtocol.primaryCompletionDate
Map:CTRPv3.8=StudyProtocol.startDate
Map:CTRPv3.8=StudyOverallStatus.statusDate
Map:CTRR=Primary Completion Date (estimated or actual)
Map:CTRR=Completion date, estimated or actual
Map:CTRRr3=StudyOverallStatus.statusDate
Map:CTRv1.0=StudyOverallStatus.date
Map:HSDBv1.0=[Study status] .temporary closure start date
Map:HSDBv1.0=[Study status] .Study Start Date
Map:HSDBv1.0=[Study status] .Current Trial Status Date
Map:HSDBv1.0=[Study status] .Primary Completion Date
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) on which the overall status of the study is assigned.#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;
Public CD
  studyStoppedReasonCode
Details:
Map:CTGOV=Why Study Stopped
Map:CTRPv1.0=StudyOverallStatus.studyStoppedReasonCode
Map:CTRPv3.8=StudyOverallStatus.studyStoppedReasonCode
Map:CTRRr3=StudyOverallStatus.studyStoppedReasonCode
Map:CTRv1.0=StudyOverallStatus.studyStoppedReasonCode
Map:HSDBv1.0=[Study status] .Why Study Stopped?
Map:HSDBv1.0=[Study status] .temporary closure status
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying why the study has been halted or terminated (for suspended, terminated or withdrawn studies). #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;1=Accrual Goal Met, 2=Closed due to toxicity, 3=Closed due to lack of study progress, 4=Temporarily closed per study design.#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;These codes are typically assigned locally.#lt;br /#gt;#lt;/p#gt;
Public BL
  anticipatedIndicator
Details:
Map:CTRPv1.0=StudyOverallStatus.anticipatedIndicator
Map:CTRPv1.0=ObservationalStudyProtocol.primaryCompletionDateTypeCode
Map:CTRPv1.0=StudyProtocol.startDateTypeCode
Map:CTRPv1.0=InterventionalStudyProtocol.primaryCompletionDateTypeCode
Map:CTRPv1.0=StudyProtocol.primaryCompletionDateTypeCode
Map:CTRPv1.0=ObservationalStudyProtocol.startDateTypeCode
Map:CTRPv1.0=InterventionalStudyProtocol.startDateTypeCode
Map:CTRPv3.8=StudyOverallStatus.statusTypeCode
Map:CTRPv3.8=StudyProtocol.startDateTypeCode
Map:CTRPv3.8=StudyProtocol.primaryCompletionDateTypeCode
Map:CTRR=Primary Completion Date (estimated or actual)
Map:CTRR=Completion date, estimated or actual
Map:CTRRr3=StudyOverallStatus.anticipatedIndicator
Map:CTRv1.0=StudyOverallStatus.anticipatedIndicator
Map:HSDBv1.0=[Study status] .Primary Completion Date Type
Map:HSDBv1.0=[Study status] .Study Start Date Type
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether the overall status of the study is an estimate.#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;#lt;p#gt;BRIDG SCC has made the decision to add an anticipatedIndicator until we learn the business rules of how the overall study status could be derived.#lt;br /#gt;#lt;/p#gt;
Public ST
  comment
Details:
Map:CTRPv1.0=StudyOverallStatus.commentText
Map:CTRPv3.8=StudyOverallStatus.commentText
Map:CTRRr3=StudyOverallStatus.comment
Map:CTRv1.0=StudyOverallStatus.comment
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Additional description of the overall status of the study.#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
StudyConduct
Class   		Name: describingStudyOverallStatus
  		Name: describedStudyConduct
 
Details:
DESCRIPTION:<br /></p><p>Each StudyOverallStatus always describes one StudyConduct. Each StudyConduct might be described by one or more StudyOverallStatus.<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:CTRPv1.0 StudyOverallStatus
Details:
 
Map:CTRPv3.8 StudyOverallStatus
Details:
 
Map:CTRRr3 StudyOverallStatus
Details:
 
Map:CTRv1.0 StudyOverallStatus
Details:
 
Map:HL7SP Study.subjectOf1
Details: