Which option lists the acceptable locations for documenting shipping records for investigational products?

Which option lists the acceptable locations for documenting shipping records for investigational products?

• A. Investigator/Institution
• B. Sponsor
• C. Investigator/Institution and Sponsor
• D. Third Party

Answer: (C)

Shipping records for investigational products must be maintained at both the investigator/institution and the sponsor. This dual documentation creates a complete, auditable trail from shipment to receipt, storage, dispensing, and eventual destruction, ensuring traceability of each lot, quantity, and condition and confirming that handling complies with protocol requirements and regulatory expectations. If records are kept only at one party, oversights or gaps can occur, hindering oversight, audits, and the ability to verify proper accountability. A third party may handle shipping, but the essential documentation must be accessible to and maintained by both the sponsor and the investigator to satisfy sponsor oversight and regulatory inspection needs.

Shipping records for investigational products must be maintained at both the investigator/institution and the sponsor. This dual documentation creates a complete, auditable trail from shipment to receipt, storage, dispensing, and eventual destruction, ensuring traceability of each lot, quantity, and condition and confirming that handling complies with protocol requirements and regulatory expectations. If records are kept only at one party, oversights or gaps can occur, hindering oversight, audits, and the ability to verify proper accountability. A third party may handle shipping, but the essential documentation must be accessible to and maintained by both the sponsor and the investigator to satisfy sponsor oversight and regulatory inspection needs.