- The DA domain is only needed if this information will be collected for the study.
- There may need to be a clear understanding of how the drugs are identified (e.g., by subject, by masked ID) in order to set up data collection in a manner that makes sense. This is a cross-functional team issue that, if applicable, needs to be addressed early in planning.
- Drug accountability may be implemented for an entire study or on a visit-by-visit basis depending on the most logical approach for the protocol.
- The DA panel can be used for studies that allow dispensing different types of study treatment (e.g., study medication, rescue medication, run-in medication) by using the DACAT variable to differentiate treatment types.
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