| Business Data Model Data Model |
Description | An administrative activity in which an authorized party at a designated study site dispenses or receives a study agent to or from a study subject. For example: Study Subject receives a bottle of pills. Original units can be derived from the translation attribute of the PQ data type on Performed Study Agent Transfer.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 Study Agent class would only be used to connect Product to Study Protocol. 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 Study Agent for a given Study Protocol. It should be noted that this determination could be different for different studies and could evolve over the course of a given study. |
Attributes | |
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Relationship | |
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Generalization | |
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Attribute Details |
Description | The amount and unit of study agent transferred in original units. Original units can be derived from the translation attribute of the PQ data type Performed Study Agent Transfer Quantity. |
Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Description | The amount and unit of study agent transferred in standard or canonical units. |
Data Type | Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER] |
Is Part Of PrimaryKey | false |
Is Required | false |
Is Derived | false |
Is Surrogate Key | false |
Relationship Details |
Description | |
Is Identifying Relationship | false |
Child Table | Performed Study Agent Transfer |
Child Role Name | transferredProduct |
Child Multiplicity | ZERO_TO_MANY |
Child Referential Integrity: On Delete | RESTRICT |
Child Referential Integrity: On Insert | NONE |
Child Referential Integrity: On Update | RESTRICT |
Parent Table | Product |
Parent Role Name | transferringPerformedStudyAgentTransfer |
Parent Multiplicity | ONE |
Parent Referential Integrity: On Delete | NONE |
Parent Referential Integrity: On Insert | RESTRICT |
Parent Referential Integrity: On Update | RESTRICT |
Generalization Details |
Supertype | Administrative Activity |
Subtype | Performed Study Agent Transfer |
Transform As | TABLE |
| Business Data Model Data Model |