: Public Class
Created: 4/12/2012 10:40:04 AM
Modified: 8/26/2017 2:57:08 AM
Project:
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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/>
Attribute
Public PQ.TIME
  delayDuration
Details:
Map:AE=ActionTaken.delayDuration
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
Notes: DEFINITION:<br/>The time delay between an observation result being determined and a resulting performed activity action being taken.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
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/>
PerformedObservationResult
Class  
Name: triggeredObservationResultActionTakenRelationship
 
Name: triggeringPerformedObservationResult
 
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/>
Tag Value
Map:AE ProductInvestigation.productReturnedIndicator
Details:
 
Map:AE ActionTaken
Details:
 
Map:AE ProductInvestigation.remedialActionTaken
Details:
 
Map:CTRv1.0 ProductActionTakenRelationship
Details:
 
Map:CTRv1.0 AdverseEventActionTakenRelationship
Details:
 
Map:CTRv1.0 ObservationResultActionTakenRelationship
Details:
 
Map:NCI CRF Standard CDE 2435042v1.2: Protocol Deviation Action Text
Details: