| Created: | 6/25/2007 10:31:24 PM |
| Modified: | 8/26/2017 1:19:09 AM |
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DEFINITION:<br/>The completed process of evaluating a product.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The evaluation process may occur either before or after the product is returned to the manufacturer or reprocessor.<br/>
- Associations To
- Tagged Values
- Constraints
- Other Links
| Element | Source Role | Target Role |
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AdverseEvent Class |
Name: triggeredPerformedProductInvestigation |
Name: triggeringAdverseEvent |
 Details:
DESCRIPTION:<br/>Each PerformedProductInvestigation always is triggered by one AdverseEvent. Each AdverseEvent might trigger one or more PerformedProductInvestigation. <br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
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PerformedProductProblemDiscovery Class |
Name: triggeredPerformedProductInvestigation |
Name: triggeringPerformedProductProblemDiscovery |
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Details:
DESCRIPTION:<br/>Each PerformedProductInvestigation always is triggered by one or more PerformedProductProblemDiscovery. Each PerformedProductProblemDiscovery might trigger one or more PerformedProductInvestigation.<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 | ProductInvestigation |
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| Map:CTRv1.0 | PerformedProductInvestigation |
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| Map:ICSRr2 | Subject5 (in IndividualCaseSafetyReport) |
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| Map:ICSRr2 | Subject6 (in IndividualCaseSafetyReport) |
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| Map:ICSRr2 | ProductDefectAssessment (in IndividualCaseSafetyReport) |
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| Constraint | Type | Status |
| be participated in by Qualifier | Invariant | Approved |
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Details:
Associations from Subject (including StudySubject) are valid only for Product, not for BiologicEntity, BiologicEntityGroup, Specimen, HealthcareFacility or Organization. Associations from ExperimentalUnit are not valid. <br/>
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| is triggered by Exclusive Or | Invariant | Approved |
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Details:
A PerformedProductInvestigation is triggered by one and only one of the following: AdverseEvent, PerformedProductProblemDiscovery.<br/>
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| Object | Type | Connection | Direction | Notes |
| PerformedObservation | Class | Generalization | To | DESCRIPTION: Each PerformedProductInvestigation always specializes one PerformedObservation. Each PerformedObservation might be specialized by one PerformedProductInvestigation. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S): |