: Public Class
Created: 7/24/2009 7:26:05 PM
Modified: 3/18/2018 6:51:43 PM
Project:
Advanced:
DEFINITION:<br/>An administrative activity defined at a global library level that is an action in which an authorized party at a designated study site dispenses or receives a study agent to/from a study subject, though as a defined activity, no actual study subject is identified.<br/><br/>EXAMPLE(S):<br/>Dispensing a bottle of pills<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<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/>
Element Source Role Target Role
Product
Class   		Name: transferringDefinedStudyAgentTransfer
  		Name: transferredProduct
 
Details:
DESCRIPTION:<br/>Each DefinedStudyAgentTransfer always is a transfer of one Product. Each Product might be transferred during one or more DefinedStudyAgentTransfer.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:CDMHv1.0 DefinedStudyAgentTransfer
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 actualIndicator Qualifier Invariant Approved
Details:
Only Product with actualIndicator = "false" is 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 DefinedStudyAgentTransfer.<br/>
Object Type Connection Direction Notes
DefinedAdministrativeActivity Class Generalization To DESCRIPTION: Each DefinedStudyAgentTransfer always specializes one DefinedAdministrativeActivity. Each DefinedAdministrativeActivity might be specialized by one DefinedStudyAgentTransfer. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):