: Public Class
Created: 3/12/2008 3:09:31 PM
Modified: 2/23/2012 3:23:29 PM
Project:
Advanced:
DEFINITION:<br /></p><p>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 /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>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 /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
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:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying a further classification of type.#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;“Adverse Event Report” would map to Document.typeCode and “7-day AE Report” would map to SafetyReportVersion.subtypeCode.#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
  nullificationReasonCode
Details:
Map:AE=SafetyReport.reasonCode
Map:AE=NullificationReport.nullificationReasonCode
Map:CTRv1.0=SafetyReportVersion.nullificationReasonCode
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying why the adverse event report is nullified.#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 BL
  nullificationIndicator
Details:
Map:AE=SafetyReport.nullificationReportInd
Map:CTRv1.0=SafetyReportVersion.nullificationIndicator
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether the report cancels a previously sent adverse event.#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
PerformedProcedure
Class   		Name: reportingSafetyReportVersion
  		Name: reportedPerformedProcedure
 
Details:
DESCRIPTION:<br /></p><p>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 /></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>
PerformedProductProblemDiscovery
Class   		Name: describingSafetyReportVersion
  		Name: describedPerformedProductProblemDiscovery
 
Details:
DESCRIPTION:<br /></p><p>Each SafetyReportVersion might describe one or more PerformedProductProblemDiscovery.  Each PerformedProductProblemDiscovery might be described by one or more SafetyReportVersion.<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>
AdverseEvent
Class   		Name: describingSafetyReportVersion
  		Name: describedAdverseEvent
 
Details:
DESCRIPTION:<br /></p><p>Each SafetyReportVersion might describe one or more AdverseEvent.  Each AdverseEvent might be described by one or more SafetyReportVersion.<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>
Element Source Role Target Role
PerformedObservation
Class   		Name: commentingPerformedObservation
  		Name: commentedSafetyReportVersion
 
Details:
DESCRIPTION:<br /></p><p>Each PerformedObservation might be commenting on one SafetyReportVersion. Each SafetyReportVersion might be commented on by one or more PerformedObservation.<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>
ReportSubmitter
Class   		Name: submittingReportSubmitter
  		Name: submittedSafetyReportVersion
 
Details:
DESCRIPTION:<br /></p><p>Each ReportSubmitter always submits one SafetyReportVersion. Each SafetyReportVersion always is submitted by one or more ReportSubmitter.<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: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.
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):