: Public Class
Created: 7/26/2007 8:55:27 AM
Modified: 8/26/2017 2:57:17 AM
Project:
Advanced:
DEFINITION:<br/>The completed action in which an authorized party at a designated study site dispenses or receives a study agent to/from a study subject.<br/><br/>EXAMPLE(S):<br/>StudySubject receives a bottle of pills.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Original units can be derived from the translation attribute of the PQ data type on PerformedStudyAgentTransfer.quantity.<br/><br/>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.<br/>
Attribute
Public PQ
  quantity
Details:
Map:CDMHv1.0=PerformedStudyAgentTransfer.quantity
Map:CTRv1.0=PerformedStudyAgentTransfer.quantity
Map:SDTM IGv3.1.1=DA.DAORRESU
Map:SDTM IGv3.1.1=DA.DASTRESC
Map:SDTM IGv3.1.1=DA.DAORRES
Map:SDTM IGv3.1.2=DA.DASTRESN
Map:SDTM IGv3.1.2=DA.DASTRESU
Map:SDTM IGv3.1.3=DA.DASTRESN
Map:SDTM IGv3.1.3=DA.DASTRESU
Notes: DEFINITION:<br/>The amount and unit of study agent transferred in standard or canonical units.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public PQ
  originalQuantity
Details:
Map:CDASHv1.1=DA.DAORRES
Map:CDASHv1.1=DA.DAORRESU
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
Map:SDTM IGv3.1.3=DA.DAORRES
Map:SDTM IGv3.1.3=DA.DAORRESU
Notes: DEFINITION:<br/>The amount and unit of study agent transferred in original units.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Original units can be derived from the translation attribute of the PQ data type PerformedStudyAgentTransfer.quantity.<br/>
Public PQ.TIME
  daysSupply
Details:
Map:CDMHv1.0=PerformedStudyAgentTransfer.daysSupply
Notes: DEFINITION:<br/>The number of days that the transferred agent supports based on the number of doses.<br/><br/>EXAMPLE(S):   <br/><br/>OTHER NAME(S):<br/>RxSup<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
StudySiteResearchCoordinator
Class   		Name: authorizedPerformedStudyAgentTransfer
  		Name: authorizingStudySiteResearchCoordinator
 
Details:
DESCRIPTION:<br/>Each PerformedStudyAgentTransfer might be authorized by one StudySiteResearchCoordinator. Each StudySiteResearchCoordinator might authorize one or more PerformedStudyAgentTransfer.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Product
Class   		Name: transferringPerformedStudyAgentTransfer
  		Name: transferredProduct
 
Details:
DESCRIPTION:<br/>Each PerformedStudyAgentTransfer always is a transfer of one Product. Each Product might be transferred during one or more PerformedStudyAgentTransfer.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:CDMHv1.0 PerformedStudyAgentTransfer
Details:
 
Map:CTRv1.0 PerformedStudyAgentTransfer
Details:
 
Map:SDTM IGv3.1.2 DA.DOMAIN
Details:
 
Map:SDTM IGv3.1.3 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.<br/>
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.<br/>
is a transfer of actualIndicator Qualifier Invariant Approved
Details:
Only Product with actualIndicator = "true" is valid.<br/>
be authorized by actualIndicator Qualifier Invariant Approved
Details:
Only Person (via StudySiteResearchCoordinator) with actualIndicator = "true" is valid.<br/>
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):