The sponsor's procedures should include actions for unused investigational product. Which action is correct?

• A. Dispensing, retrieval from subjects, and return to sponsor
• B. Advertising unused product
• C. Discontinuation of the trial
• D. Public release of subject data

Answer: (A)

Managing unused investigational product and ensuring proper accountability is what the sponsor's procedures must cover. The correct approach includes dispensing the IP to subjects, retrieving any unused IP from subjects when treatment ends or a subject withdraws, and returning it to the sponsor for reconciliation or disposal according to protocol and regulatory requirements. This sequencing maintains accurate inventory, preserves chain of custody, and supports safety and regulatory compliance. Advertising unused product would be inappropriate and prohibited; discontinuation of the trial or public release of subject data do not address the proper handling and disposition of unused IP.