PerformedStudyAgentTransfer

: Public Class

Created:	7/26/2007 8:55:27 AM
Modified:	5/24/2013 5:37:20 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{C5D53CCB-DB71-4979-BF52-F68086E0BBDF}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View SC: Study Conduct

DEFINITION: The completed action in which an authorized party at a designated study site dispenses or receives a study agent to/from a study subject. EXAMPLE(S): StudySubject receives a bottle of pills. OTHER NAME(S): NOTE(S): Original units can be derived from the translation attribute of the PQ data type on PerformedStudyAgentTransfer.quantity. The term "study agent" only pertains within the context of a given study. To make this explicit in BRIDG it was determined that the StudyAgent class would only be used to connect Product to StudyProtocolVersion. All activity-related classes would be associated directly to Product to avoid the issues of activities that may cross study boundaries. To determine if a given activity uses a study agent one need only compare the product used in the activity with the list of products associated to StudyAgent for a given StudyProtocolVersion. It should be noted that this determination could be different for different studies and could evolve over the course of a given study.

Attributes
Associations To
Tagged Values
Constraints
Other Links

Attribute

Public PQ
quantity

Details:

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

Map:CTRv1.0=PerformedStudyAgentTransfer.quantity
Map:SDTM IGv3.1.1=DA.DASTRESC
Map:SDTM IGv3.1.1=DA.DAORRESU
Map:SDTM IGv3.1.1=DA.DAORRES
Map:SDTM IGv3.1.2=DA.DASTRESU
Map:SDTM IGv3.1.2=DA.DASTRESN

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The amount and unit of study agent transferred in standard or canonical units.#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;

Public PQ
originalQuantity

Details:

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

Map:CDASHv1.1=DA.DAORRESU
Map:CDASHv1.1=DA.DAORRES
Map:CTRv1.0=PerformedStudyAgentTransfer.originalQuantity
Map:SDTM IGv3.1.1=DA.DAORRESU
Map:SDTM IGv3.1.1=DA.DAORRES
Map:SDTM IGv3.1.2=DA.DAORRESU
Map:SDTM IGv3.1.2=DA.DAORRES

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The amount and unit of study agent transferred in original units.#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;#lt;p#gt;Original units can be derived from the translation attribute of the PQ data type PerformedStudyAgentTransfer.quantity.#lt;br /#gt;#lt;/p#gt;

Element	Source Role	Target Role
StudySiteResearchCoordinator Class	Name: authorizedPerformedStudyAgentTransfer	Name: authorizingStudySiteResearchCoordinator
Details: DESCRIPTION:<br /></p><p>Each PerformedStudyAgentTransfer might be authorized by one StudySiteResearchCoordinator. Each StudySiteResearchCoordinator might authorize one or more PerformedStudyAgentTransfer.<br /></p><p><br /></p><p>DEFINITION:<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>
Product Class	Name: transferringPerformedStudyAgentTransfer	Name: transferredProduct
Details: DESCRIPTION:<br /></p><p>Each PerformedStudyAgentTransfer always is a transfer of one Product. Each Product might be transferred during one or more PerformedStudyAgentTransfer.<br /></p><p><br /></p><p>DEFINITION:<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:CTRv1.0	PerformedStudyAgentTransfer
Details:
Map:SDTM IGv3.1.2	DA.DOMAIN
Details:
Map:SDTMIGv3.1.3	DA
Details:

Constraint	Type	Status
be participated in by Qualifier	Invariant	Approved
Details: Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid.
is a transfer of Qualifier	Invariant	Approved
Details: Associations from Product are valid only for Products that are associated to StudyAgent with the same StudyProtocolVersion as the StudyProtocolVersion associated to the PerformedStudyAgentTransfer.
is a transfer of actualIndicator Qualifier	Invariant	Approved
Details: Only Product with actualIndicator = "true" is valid.
be authorized by actualIndicator Qualifier	Invariant	Approved
Details: Only Person (via StudySiteResearchCoordinator) with actualIndicator = "true" is valid.

Object	Type	Connection	Direction	Notes
PerformedAdministrativeActivity	Class	Generalization	To	DESCRIPTION: Each PerformedStudyAgentTransfer always specializes one PerformedAdministrativeActivity. Each PerformedAdministrativeActivity might be specialized by one PerformedStudyAgentTransfer. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):