| Created: | 7/24/2009 7:26:05 PM |
| Modified: | 8/21/2012 9:53:43 AM |
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| Advanced: |
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DEFINITION:<br /></p><p>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 /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Dispensing a bottle of pills<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>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 /></p>
- Associations To
- Constraints
- Other Links
| Element | Source Role | Target Role |
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Product Class |
Name: transferringDefinedStudyAgentTransfer |
Name: transferredProduct |
 Details:
DESCRIPTION:<br /></p><p>Each DefinedStudyAgentTransfer always is a transfer of one Product. Each Product might be transferred during one or more DefinedStudyAgentTransfer.<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>
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| Constraint | Type | Status |
| be participated in by Qualifier | Invariant | Approved |
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Details:
Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid.
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| is a transfer of actualIndicator Qualifier | Invariant | Approved |
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Details:
Only Product with actualIndicator = "false" is valid.
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| is a transfer of Qualifier | Invariant | Approved |
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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.
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| 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): |