What happens to remaining drugs from an investigational study when the study is complete?

What happens to remaining drugs from an investigational study when the study is complete?

• A. They are discarded
• B. They are returned to the sponsor with the record logs
• C. They are given to participants
• D. They are stored for future use in the facility

Answer: (B)

When a clinical study ends, the unused investigational drug materials are owned by the sponsor and must be accounted for. The proper action is to return any remaining stock to the sponsor, along with the drug accountability records that document quantities, lot numbers, expiration dates, dates of return, and the disposition. Returning them with the logs ensures traceability, proper oversight, and compliance with regulatory requirements, and it lets the sponsor arrange for disposal or reuse as appropriate. Discarding leftovers at the site, giving them to participants, or keeping them for future use without sponsor direction would bypass required controls and could create safety and legal issues.

When a clinical study ends, the unused investigational drug materials are owned by the sponsor and must be accounted for. The proper action is to return any remaining stock to the sponsor, along with the drug accountability records that document quantities, lot numbers, expiration dates, dates of return, and the disposition. Returning them with the logs ensures traceability, proper oversight, and compliance with regulatory requirements, and it lets the sponsor arrange for disposal or reuse as appropriate. Discarding leftovers at the site, giving them to participants, or keeping them for future use without sponsor direction would bypass required controls and could create safety and legal issues.