: Public Class
Created: 7/26/2007 10:14:37 AM
Modified: 2/23/2012 4:27:24 PM
Project:
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DEFINITION:<br /></p><p>A designation of an event as a variation from process or procedures defined in a study protocol.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Study subject not withdrawn as per protocol, excluded concomitant medication, treatment deviation.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety.<br /></p>
Attribute
Public CD
  categoryCode
Details:
Map:CTRv1.0=PerformedProtocolDeviation.categoryCode
Map:NCI CRF Standard=CDE 2740412v1.0: Protocol Deviation Category
Map:NCI CRF Standard=CDE 2740419v1.0: Protocol Deviation Other Category Descriptive Text
Map:SDTM IGv3.1.1=DV.DVCAT
Map:SDTM IGv3.1.2=DV.DVCAT
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying a classification of protocol deviation.#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;Concomitant Medications, Data Integrity Compromised, Eligibility not checked, Eligibility waiver, Informed Consent, Other specify, Study Procedures, Treatment [NCI CRF Standard examples]#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
  subcategoryCode
Details:
Map:CTRv1.0=PerformedProtocolDeviation.subcategoryCode
Map:SDTM IGv3.1.2=DV.DVSCAT
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying a subdivision within a larger category of a protocol deviation.#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
  severityCode
Details:
Map:NCI CRF Standard=CDE 2740401v1.0: Protocol Deviation Severity Type
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the intensity of a protocol deviation.#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;major, moderate, minor#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 IVL<TS.DATETIME>
  occurrenceDateRange
Details:
Map:CDASHv1.1=DV.DVSTDAT
Map:CDASHv1.1=DV.DVENDAT
Map:CDASHv1.1=DV.DVSTTIM
Map:CDASHv1.1=DV.DVENTIM
Map:CTRv1.0=PerformedProtocolDeviation.occurrenceDateRange
Map:NCI CRF Standard=CDE 2434998v1.0: Protocol Deviation Occurrence Date
Map:SDTM IGv3.1.1=DV.DVSTDTC
Map:SDTM IGv3.1.1=DV.DVENDTC
Map:SDTM IGv3.1.2=DV.DVENDTC
Map:SDTM IGv3.1.2=DV.DVSTDTC
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date and time span specifying when the protocol deviation began and ended.#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
StudyResearchCoordinator
Class   		Name: managedPerformedProtocolDeviation
  		Name: managingStudyResearchCoordinator
 
Details:
DESCRIPTION:<br /></p><p>Each PerformedProtocolDeviation might have management action determined by one StudyResearchCoordinator. Each StudyResearchCoordinator might determine the management action for one or more PerformedProtocolDeviation.<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>
StudySitePersonnel
Class   		Name: implementedPerformedProtocolDeviation
  		Name: implementingStudySitePersonnel
 
Details:
DESCRIPTION:<br /></p><p>Each PerformedProtocolDeviation might have management action implemented by one StudySitePersonnel. Each StudySitePersonnel might implement the management action for one or more PerformedProtocolDeviation.<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>
StudyLegalSponsor
Class   		Name: authorizedPerformedProtocolDeviation
  		Name: authorizingStudyLegalSponsor
 
Details:
DESCRIPTION:<br /></p><p>Each PerformedProtocolDeviation might be authorized by one StudyLegalSponsor.  Each StudyLegalSponsor might authorize one or more PerformedProtocolDeviation.<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 PerformedProtocolDeviation
Details:
 
Map:NCI CRF Standard ProtocolDeviation
Details:
 
Map:SDTM IGv3.1.2 DV.DOMAIN
Details:
 
Map:SDTMIGv3.1.3 DV
Details:
 
Constraint Type Status
be authorized by actualIndicator Qualifier Invariant Approved
Details:
Only Person or Organization (via StudyLegalSponsor) with actualIndicator = "true" is valid.
be managed by actualIndicator Qualifier Invariant Approved
Details:
Only Person (via StudyResearchCoordinator) with actualIndicator = "true" is valid.
be addressed by actualIndicator Qualifier Invariant Approved
Details:
Only Person (via StudySitePersonnel) with actualIndicator = "true" is valid.
Object Type Connection Direction Notes
«Comment_Requested» PerformedObservationResult Class Generalization To DESCRIPTION: Each PerformedProtocolDeviation always specializes one PerformedObservationResult. Each PerformedObservationResult might be specialized by one PerformedProtocolDeviation. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):