Study Conduct Sub-Domain::PerformedProtocolDeviation

: Public Class

Created:	7/26/2007 10:14:37 AM
Modified:	3/18/2019 11:23:36 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{4863BF50-39E8-4229-A3A4-264CD17A7E87}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View SC: Study Conduct, SDTM IG v3.1.3, SDTM IG v3.2

DEFINITION: A designation of an event as a variation from process or procedures defined in a study protocol. EXAMPLE(S): Study subject not withdrawn as per protocol, excluded concomitant medication, treatment deviation. OTHER NAME(S): NOTE(S): Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety.

Attributes
Associations To
Tagged Values
Constraints
Other Links

Attribute

Public CD
categoryCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

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
Map:SDTM IGv3.1.3=DV.DVCAT
Map:SDTM IGv3.2=DV.DVCAT

Notes:

DEFINITION: A coded value specifying a classification of protocol deviation. EXAMPLE(S): Concomitant Medications, Data Integrity Compromised, Eligibility not checked, Eligibility waiver, Informed Consent, Other specify, Study Procedures, Treatment [NCI CRF Standard examples] OTHER NAME(S): NOTE(S):

Public CD
subcategoryCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=PerformedProtocolDeviation.subcategoryCode
Map:SDTM IGv3.1.2=DV.DVSCAT
Map:SDTM IGv3.1.3=DV.DVSCAT
Map:SDTM IGv3.2=DV.DVSCAT

Notes:

DEFINITION: A coded value specifying a subdivision within a larger category of a protocol deviation. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public CD
severityCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:NCI CRF Standard=CDE 2740401v1.0: Protocol Deviation Severity Type

Notes:

DEFINITION: A coded value specifying the intensity of a protocol deviation. EXAMPLE(S): major, moderate, minor OTHER NAME(S): NOTE(S):

Public IVL<TS.DATETIME>
occurrenceDateRange

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CDASHv1.1=DV.DVSTTIM
Map:CDASHv1.1=DV.DVENDAT
Map:CDASHv1.1=DV.DVSTDAT
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.DVENDTC
Map:SDTM IGv3.1.1=DV.DVSTDTC
Map:SDTM IGv3.1.2=DV.DVENDTC
Map:SDTM IGv3.1.2=DV.DVSTDTC
Map:SDTM IGv3.1.3=DV.DVENDTC
Map:SDTM IGv3.1.3=DV.DVSTDTC
Map:SDTM IGv3.2=DV.DVENDTC
Map:SDTM IGv3.2=DV.DVSTDTC
Map:SDTM IGv3.2=DV.EPOCH

Notes:

DEFINITION: The date and time span specifying when the protocol deviation began and ended. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
StudyResearchCoordinator Class	Name: managedPerformedProtocolDeviation	Name: managingStudyResearchCoordinator
Details: DESCRIPTION:<br/>Each PerformedProtocolDeviation might have management action determined by one StudyResearchCoordinator. Each StudyResearchCoordinator might determine the management action for one or more PerformedProtocolDeviation.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StudySitePersonnel Class	Name: implementedPerformedProtocolDeviation	Name: implementingStudySitePersonnel
Details: DESCRIPTION:<br/>Each PerformedProtocolDeviation might have management action implemented by one StudySitePersonnel. Each StudySitePersonnel might implement the management action for one or more PerformedProtocolDeviation.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
StudyLegalSponsor Class	Name: authorizedPerformedProtocolDeviation	Name: authorizingStudyLegalSponsor
Details: DESCRIPTION:<br/>Each PerformedProtocolDeviation might be authorized by one StudyLegalSponsor. Each StudyLegalSponsor might authorize one or more PerformedProtocolDeviation.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:CTRv1.0	PerformedProtocolDeviation
Details:
Map:NCI CRF Standard	ProtocolDeviation
Details:
Map:SDTM IGv3.1.2	DV.DOMAIN
Details:
Map:SDTM IGv3.1.3	DV
Details:
Map:SDTM IGv3.2	DV
Details:

Constraint	Type	Status
be authorized by actualIndicator Qualifier	Invariant	Approved
Details: Only Person or Organization (via StudyLegalSponsor) with actualIndicator = "true" is valid.<br/>
be managed by actualIndicator Qualifier	Invariant	Approved
Details: Only Person (via StudyResearchCoordinator) with actualIndicator = "true" is valid.<br/>
be addressed by actualIndicator Qualifier	Invariant	Approved
Details: Only Person (via StudySitePersonnel) with actualIndicator = "true" is valid.<br/>

Object	Type	Connection	Direction	Notes
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):