Which records are required to document the shipment, receipt, disposition, return, and destruction of the investigational product?

• A. Only shipment records
• B. Only destruction records
• C. A complete set of records including shipment, receipt, disposition, return, and destruction
• D. No records are required

Answer: (C)

Documenting the full lifecycle of the investigational product is essential for accountability and compliance. Every step in the IP’s journey—shipment from sponsor to site, receipt at the site, how the IP is dispensed or used (disposition), any returns from the site, and the destruction of unused product—needs to be recorded. These records together create a complete trail of custody and inventory, which helps prevent diversion, ensures proper inventory reconciliation, and supports inspections and audits.

Shipment records show the IP was delivered to the correct site and person; receipt records confirm it arrived in the expected condition and was received by authorized personnel. Disposition records capture how much IP was used, allocated, or lost, keeping the inventory accurate. Return records document IP sent back to the sponsor or another facility and enable reconciliation with the original shipment. Destruction records verify that unusable product was disposed of properly, with the method, date, and, when required, a witness or certificate of destruction.

Partial documentation leaves gaps that can compromise safety, data integrity, and regulatory compliance, whereas a complete set of records ensures traceability, accountability, and readiness for inspection.