If an IP is not used, what should happen to unused products?

• A. Keep at site indefinitely.
• B. Discard in general waste.
• C. Hide from auditors.
• D. Return to sponsor or proper destruction or alternative disposition.

Answer: (D)

Handling unused Investigational Product (IP) centers on accountability and proper disposition. When IP isn’t used, it should be returned to the sponsor or disposed of properly, which may involve destruction or another approved disposition arranged by the sponsor and in line with regulatory and protocol requirements. This keeps inventory traceable, prevents diversion or misuse, and ensures that destruction or return is documented with the appropriate records, lot numbers, expiry dates, and chain of custody. Keeping the IP at the site indefinitely risks untracked inventory and potential regulatory or safety issues. Discarding it in general waste could pose safety and compliance problems. Hiding it from auditors is a breach of trial conduct. Returning to the sponsor or arranging proper destruction or an approved disposition maintains trial integrity and regulatory compliance.