Which document records the destruction of unused investigational products?

Which document records the destruction of unused investigational products?

• A. Audit Certificate
• B. Record of Retained Samples
• C. Documentation of Investigational Product Destruction
• D. Treatment Allocation Documentations

Answer: (C)

Destruction of unused investigational products must be tracked with a formal record to maintain clear accountability and compliance. The document that records this event provides a complete trail of what was destroyed, when, by whom, and how, including quantities or lot numbers, disposal method, location, and any witnesses. This ensures that no unused IP remains in circulation and that the disposal complies with the protocol and applicable regulations. Keeping this record supports audit readiness and regulatory inspections by verifying proper destruction and preventing misallocation or misuse of the IP. Other documents don’t capture the destruction event itself. An Audit Certificate relates to audits conducted, not the act of destroying IP. A Record of Retained Samples tracks samples kept for testing or controls, not disposal. Treatment Allocation Documentation records what treatment a participant received, not how IP was disposed.

Destruction of unused investigational products must be tracked with a formal record to maintain clear accountability and compliance. The document that records this event provides a complete trail of what was destroyed, when, by whom, and how, including quantities or lot numbers, disposal method, location, and any witnesses. This ensures that no unused IP remains in circulation and that the disposal complies with the protocol and applicable regulations. Keeping this record supports audit readiness and regulatory inspections by verifying proper destruction and preventing misallocation or misuse of the IP.

Other documents don’t capture the destruction event itself. An Audit Certificate relates to audits conducted, not the act of destroying IP. A Record of Retained Samples tracks samples kept for testing or controls, not disposal. Treatment Allocation Documentation records what treatment a participant received, not how IP was disposed.