| Created: | 4/12/2012 10:40:04 AM |
| Modified: | 8/26/2017 2:57:08 AM |
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DEFINITION:<br/>Specifies the link between an observation result and the actions taken as a result of that outcome.<br/><br/>EXAMPLE(S):<br/>An electrical problem (product investigation result) in a device could result in a recall (product action taken) of the device.<br/><br/>An abnormal lab result triggers a follow-up lab test for further investingation.<br/><br/>Study dose reduced or protocol treatment change due to an adverse event.<br/><br/>OTHER NAME(S):<br/>AdverseEventActionTakenRelationship, ProductActionTakenRelationship<br/><br/>NOTE(S): <br/>Action taken relationship is generally used for "unplanned" activities rather than those already determined in "contingent" relationships in the planned study design.<br/>
- Attributes
- Associations To
- Tagged Values
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Public PQ.TIME delayDuration |
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Details:
Map:AE=ProductInvestigation.remedialActionTaken Map:CTOM=AdverseEventTherapy.delayDuration Map:CTOM=AdverseEventTherapy.delayDurationUnitOfMeasureCode Map:CTRv1.0=ProductActionTakenRelationship.delayDuration Map:CTRv1.0=ObservationResultActionTakenRelationship.delayDuration Map:CTRv1.0=AdverseEventActionTakenRelationship.delayDuration
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| Element | Source Role | Target Role |
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PerformedActivity Class |
Name: triggeringObservationResultActionTakenRelationship |
Name: triggeredPerformedActivity |
 Details:
DESCRIPTION:<br/>Each ObservationResultActionTakenRelationship always triggers one PerformedActivity. Each PerformedActivity might be triggered by one or more ObservationResultActionTakenRelationship.<br/><br/>DEFINITION:<br/>Indicates the PerformedActivity undertaken as a result of an ObservationResult<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
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PerformedObservationResult Class |
Name: triggeredObservationResultActionTakenRelationship |
Name: triggeringPerformedObservationResult |
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Details:
DESCRIPTION:<br/>Each ObservationResultActionTakenRelationship always is triggered by one PerformedObservationResult. Each PerformedObservationResult might trigger one or more ObservationResultActionTakenRelationship.<br/><br/>DEFINITION:<br/>Indicates the ObservationResult that causes the initiation of a PerformedActivity<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
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| Tag | Value |
| Map:AE | ProductInvestigation.productReturnedIndicator |
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| Map:AE | ActionTaken |
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| Map:AE | ProductInvestigation.remedialActionTaken |
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| Map:CTRv1.0 | ProductActionTakenRelationship |
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| Map:CTRv1.0 | AdverseEventActionTakenRelationship |
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| Map:CTRv1.0 | ObservationResultActionTakenRelationship |
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| Map:NCI CRF Standard | CDE 2435042v1.2: Protocol Deviation Action Text |
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