What records should be maintained regarding investigational products?

• A. Only delivery records.
• B. No records required if product is approved.
• C. Delivery, inventory, use by each participant, return to sponsor, destruction or alternative disposition of unused products.
• D. Only destruction records.

Answer: (C)

Tracking the investigational product through its entire life cycle is essential for accountability, safety, and data integrity. You should maintain delivery records that show when and from whom the IP was received, including batch/lot numbers. Keep inventory records to know current stock, location, quantities, and expiration dates. Record use by each participant to link the IP to the specific subject, dose, date, and administering personnel. Document the return of unused IP to the sponsor and any destruction or alternative disposition of unused products, with details on method, date, and rationale. This complete chain-of-custody is required even if the product is approved, because in a trial the product is being used under a protocol and must be tracked meticulously. These records support monitoring, auditing, regulatory compliance, and the integrity of the trial data.