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  1. The DA domain is only needed if this information will be collected for the study.
  2. 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.
  3. CRF collects the amount of study product transferred to or from the study subject. Hence, if no study product is transferred to a subject this CRF may not be needed.
  4. Product 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.