Which document records the final accounting of investigational products at the site?

• A. Final Trial Close-Out Monitoring Report
• B. Completed Subject Identification Code List
• C. Investigational Products Accountability at Site
• D. Audit Certificate

Answer: (C)

Tracking investigational products at the site is essential to ensure proper use, prevent diversion, and support reconciliation with the sponsor. The document that records the final accounting of investigational products at the site is the Investigational Products Accountability at Site. It captures receipts, dispensation, returns, wastage or destruction, and the final inventory on hand, providing a reconciliation between what the site has and what the sponsor issued. This ensures complete and accurate IP records at trial end and supports regulatory inspections and audits. It is maintained by the investigator or designee and includes details like lot numbers, quantities, dates, and signatures.

That other documents serve different purposes: a Final Trial Close-Out Monitoring Report covers overall trial close-out; a Completed Subject Identification Code List protects subject confidentiality; an Audit Certificate confirms an audit was conducted, not the IP inventory at the site.