: Public Class
Created: 3/12/2008 3:09:31 PM
Modified: 2/27/2019 12:55:29 AM
Project:
Advanced:
DEFINITION:<br/>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.<br/><br/>EXAMPLE(S):<br/>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.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public CD
  subtypeCode
Details:
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:<br/>A coded value specifying a further classification of type.<br/><br/>EXAMPLE(S):<br/>“Adverse Event Report” would map to Document.typeCode and “7-day AE Report” would map to SafetyReportVersion.subtypeCode.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public BL
  nullificationIndicator
Details:
Map:AE=SafetyReport.nullificationReportInd
Map:CTRv1.0=SafetyReportVersion.nullificationIndicator
Notes: DEFINITION:<br/>Specifies whether the report cancels a previously sent adverse event.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  nullificationReasonCode
Details:
Map:AE=SafetyReport.reasonCode
Map:AE=NullificationReport.nullificationReasonCode
Map:CTRv1.0=SafetyReportVersion.nullificationReasonCode
Notes: DEFINITION:<br/>A coded value specifying why the adverse event report is nullified.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
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/>
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/>
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):