| Created: | 6/7/2007 3:59:14 PM |
| Modified: | 3/18/2018 6:51:48 PM |
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DEFINITION:<br/>The judgment of relatedness between an adverse event and an activity or observation result.<br/><br/>EXAMPLE(S):<br/>The observation result of "diabetes" is assessed to have caused the AE.<br/><br/>The activity of administering a concomitant medication is assessed to have caused the AE.<br/><br/>The activity of administering the study drug is assessed to have caused the AE.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
- Associations To
- Associations From
- Tagged Values
- Constraints
- Other Links
| Element | Source Role | Target Role |
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AdverseEvent Class |
Name: triggeredCausalAssessment |
Name: triggeringAdverseEvent |
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DESCRIPTION:<br/>Each CausalAssessment always is triggered by one AdverseEvent. Each AdverseEvent might trigger one or more CausalAssessment.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
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| Element | Source Role | Target Role |
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EvaluatedResultRelationship Class |
Name: evaluatedEvaluatedResultRelationship |
Name: evaluatingCausalAssessment |
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Details:
DESCRIPTION:<br/>Each EvaluatedResultRelationship always is evaluated by one CausalAssessment. Each CausalAssessment might evaluate one or more EvaluatedResultRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
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EvaluatedActivityRelationship Class |
Name: evaluatedEvaluatedActivityRelationship |
Name: evaluatingCausalAssessment |
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Details:
DESCRIPTION:<br/>Each EvaluatedActivityRelationship always is evaluated by one CausalAssessment. Each CausalAssessment might evaluate one or more EvaluatedActivityRelationship.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
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| Tag | Value |
| Map:AE | CausalAssessment |
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| Map:CDMHv1.0 | CausalAssessment |
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| Map:CTRv1.0 | CausalAssessment |
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| Map:ICSRr2 | AdverseEffectReference (in IndividualCaseSafetyReport) |
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| Map:ICSRr2 | Subject2 (in IndividualCaseSafetyReport) |
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| Map:ICSRr2 | Subject4 (in IndividualCaseSafetyReport) |
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| Map:ICSRr2 | CausalityAssessment (in IndividualCaseSafetyReport) |
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| Map:ICSRr2 | Component1 (in IndividualCaseSafetyReport) |
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| Constraint | Type | Status |
| be participated in by Qualifier | Invariant | Approved |
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Associations from Subject (including StudySubject) are valid for BiologicEntity and BiologicEntityGroup, not for Product, Specimen, HealthcareFacility or Organization. Associations from ExperimentalUnit are not valid. <br/>
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| Object | Type | Connection | Direction | Notes |
| PerformedObservation | Class | Generalization | To | DESCRIPTION: Each CausalAssessment always specializes one PerformedObservation. Each PerformedObservation might be specialized by one CausalAssessment. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S): |