ObservationResultActionTakenRelationship

: Public Class

Created:	4/12/2012 10:40:04 AM
Modified:	5/29/2013 3:09:12 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{BCCC7A51-59A7-4db6-B51D-1DA4E182A03C}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View AE: Adverse Event, View SC: Study Conduct

DEFINITION: Specifies the link between an observation result and the actions taken as a result of that outcome. EXAMPLE(S): An electrical problem (product investigation result) in a device could result in a recall (product action taken) of the device. An abnormal lab result triggers a follow-up lab test for further investingation. Study dose reduced or protocol treatment change due to an adverse event. OTHER NAME(S): AdverseEventActionTakenRelationship, ProductActionTakenRelationship NOTE(S): Action taken relationship is generally used for "unplanned" activities rather than those already determined in "contingent" relationships in the planned study design.

Attributes
Associations To
Tagged Values

Attribute

Public PQ.TIME
delayDuration

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

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:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The time delay between an observation result being determined and a resulting performed activity action being taken.#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
«Comment_Requested» PerformedObservationResult Class	Name: triggeredObservationResultActionTakenRelationship	Name: triggeringPerformedObservationResult
Details: DESCRIPTION:<br /></p><p>Each ObservationResultActionTakenRelationship always is triggered by one PerformedObservationResult. Each PerformedObservationResult might trigger one or more ObservationResultActionTakenRelationship.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Indicates the ObservationResult that causes the initiation of a PerformedActivity<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>
PerformedActivity Class	Name: triggeringObservationResultActionTakenRelationship	Name: triggeredPerformedActivity
Details: DESCRIPTION:<br /></p><p>Each ObservationResultActionTakenRelationship always triggers one PerformedActivity. Each PerformedActivity might be triggered by one or more ObservationResultActionTakenRelationship.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Indicates the PerformedActivity undertaken as a result of an ObservationResult<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	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: