Adverse Event Sub-Domain::SafetyReportVersion

: Public Class

Created:	3/12/2008 3:09:31 PM
Modified:	8/26/2017 1:19:11 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{67A32AF7-6AC8-4366-AC41-2CB43F48C801}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View AE: Adverse Event, Adverse Events

DEFINITION: A report that provides notification of an adverse event, product problem, and/or information that is relevant to either. A report typically includes causal association, management strategies, authorship, sender/receiver organizations, subject of adverse event, or name of product. EXAMPLE(S): An Expedited AE report - a report of a serious and unexpected adverse event that must be submitted within specific timeframes to the sponsor and regulatory agencies. OTHER NAME(S): NOTE(S):

Attributes
Associations To
Associations From
Tagged Values
Constraints
Other Links

Attribute

Public CD
subtypeCode

Details:

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

Map:AE=SafetyReport.reportingCriteriaCode
Map:AE=SafetyReport.problemType
Map:AE=SafetyReport.spontaneousReportInd
Map:AE=SafetyReport.expeditedReportCriteriaInd
Map:CTRv1.0=SafetyReportVersion.subtypeCode
Map:ICSRr2=InvestigativeEvent.code (in IndividualCaseSafetyReport)
Map:ICSRr2=RelatedInvestigation.code (in IndividualCaseSafetyReport)

Notes:

DEFINITION: A coded value specifying a further classification of type. EXAMPLE(S): “Adverse Event Report” would map to Document.typeCode and “7-day AE Report” would map to SafetyReportVersion.subtypeCode. OTHER NAME(S): NOTE(S):

Public BL
nullificationIndicator

Details:

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

Map:AE=SafetyReport.nullificationReportInd
Map:CTRv1.0=SafetyReportVersion.nullificationIndicator

Notes:

DEFINITION: Specifies whether the report cancels a previously sent adverse event. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public CD
nullificationReasonCode

Details:

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

Map:AE=SafetyReport.reasonCode
Map:AE=NullificationReport.nullificationReasonCode
Map:CTRv1.0=SafetyReportVersion.nullificationReasonCode

Notes:

DEFINITION: A coded value specifying why the adverse event report is nullified. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
PerformedProductProblemDiscovery Class	Name: describingSafetyReportVersion	Name: describedPerformedProductProblemDiscovery
Details: DESCRIPTION:<br/>Each SafetyReportVersion might describe one or more PerformedProductProblemDiscovery. Each PerformedProductProblemDiscovery might be described by one or more SafetyReportVersion.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
PerformedProcedure Class	Name: reportingSafetyReportVersion	Name: reportedPerformedProcedure
Details: DESCRIPTION:<br/>Each SafetyReportVersion might report as prior therapies one or more PerformedProcedure. Each PerformedProcedure might be reported as a prior therapy in one or more SafetyReportVersion.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
AdverseEvent Class	Name: describingSafetyReportVersion	Name: describedAdverseEvent
Details: DESCRIPTION:<br/>Each SafetyReportVersion might describe one or more AdverseEvent. Each AdverseEvent might be described by one or more SafetyReportVersion.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Element	Source Role	Target Role
PerformedObservation Class	Name: commentingPerformedObservation	Name: commentedSafetyReportVersion
Details: DESCRIPTION:<br/>Each PerformedObservation might be commenting on one SafetyReportVersion. Each SafetyReportVersion might be commented on by one or more PerformedObservation.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
ReportSubmitter Class	Name: submittingReportSubmitter	Name: submittedSafetyReportVersion
Details: DESCRIPTION:<br/>Each ReportSubmitter always submits one SafetyReportVersion. Each SafetyReportVersion always is submitted by one or more ReportSubmitter.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:AE	ProductProblemReport
Details:
Map:AE	SafetyReport
Details:
Map:AE	NullificationReport
Details:
Map:caAERSv2.2	ExpeditedAdverseEventReport
Details:
Map:CTRRr3	SafetyReport
Details:
Map:CTRv1.0	SafetyReportVersion
Details:
Map:ICSRr2	Subject8 (in IndividualCaseSafetyReport)
Details:
Map:ICSRr2	ControlActEvent (in IndividualCaseSafetyReport)
Details:
Map:ICSRr2	Subject9 (in IndividualCaseSafetyReport)
Details:

Constraint	Type	Status
describes Exclusive Or	Invariant	Approved
Details: A SafetyReportVersion describes one and only one of the following: AdverseEvent, PerformedProductProblemDiscovery.<br/>

Object	Type	Connection	Direction	Notes
ReportVersion	Class	Generalization	To	DESCRIPTION: Each SafetyReportVersion always specializes one ReportVersion. Each ReportVersion might be specialized by one SafetyReportVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):