[Greg Hottell]

Reply To: Clinical Supply Return Reconciliation

Investigational Product (IMP) accountability involves a combination of both GCP and GMP activities throughout the chain of custody. Sponsors are required to maintain appropriate records of IMP disposition, shipments, etc. (reference: 21 CFR 312.57(a)); while investigators are required to maintain records of IMP receipts, dispensations, returns, etc. (reference 21 CFR 312.62(a)). Full traceability is required through the life cycle of the investigational product including the final reconciliation and destruction.