Which document records shipment dates, batch numbers, and the method of shipment for investigational products and trial-related materials, enabling tracking and accountability?

• A. Shipping Records for Investigational Products and Trial-Related Materials
• B. Certificates of Analysis of Investigational Products Shipped
• C. Decoding Procedures for Blinded Trials
• D. Master Randomization List

Answer: (A)

Tracking and accountability for investigational products depend on documenting how and when materials move from sponsor to site. The document that records shipment dates, batch numbers, and the method of shipment provides a clear, auditable trail of what was sent, when it left the sponsor, who it was sent to, how it was transported, and which specific batch or lot is involved. This information is essential to verify receipt, ensure the correct product and lot were delivered, monitor storage and handling conditions, and enable traceability if any issues arise (such as product recalls or quality concerns). It also supports the integrity of inventory management and the overall chain of custody for trial materials.

Certificates of Analysis focus on confirming product quality rather than shipment details, decoding procedures pertain to blinding in trials, and a master randomization list relates to allocation rather than the physical shipment and tracking of materials.