Who is responsible for investigational product accountability at the trial site(s)?

• A. Regulatory authority.
• B. Investigator/institution.
• C. Sponsor.
• D. IRB/IEC.

Answer: (B)

The investigator/institution is responsible for investigational product accountability at the trial site. They must keep accurate records of all IMP received, stored, dispensed to subjects, and disposed of or returned, ensuring the inventory is reconciled and traceable. This on-site accountability ensures proper use, storage conditions, and timely reporting of discrepancies to the sponsor. Regulatory authorities and IRBs/IECs oversee approvals and safety oversight, not daily inventory, and while the sponsor provides the IMP and overall system, the day-to-day custody and reconciliation happen at the site under the investigator’s responsibility.