The sponsor's system for the disposition of unused IP should ensure what?

• A. Proper disposal or alternative disposition in compliance with regulatory requirements
• B. Disposal without documentation
• C. Disposal only with sponsor consent
• D. No disposal is needed

Answer: (A)

The key idea is ensuring that unused Investigational Product (IP) is handled in a controlled, auditable way that meets regulatory requirements. In a sponsor’s IP disposition system, every unused item must be accounted for and disposed of or redirected in a manner that is legally compliant and traceable. This means there’s a documented plan for what to do with the IP (return to sponsor, destruction, or another approved disposition), and the method chosen must conform to applicable laws and guidelines. The system records essential details—dates, quantities, lot numbers, reasons for disposal, the chosen disposition method, and who authorized and witnessed the action—and keeps clear records for audits or inspections. This ensures there’s no unaccounted IP and that patient safety, data integrity, and regulatory compliance are maintained.

Disposing without documentation or requiring consent as the sole condition would leave the IP untraceable and noncompliant, and doing nothing with IP isn’t appropriate once it’s unused.