What determinations should the sponsor make for the investigational product regarding storage?

• A. Only storage temperatures
• B. Acceptable storage temperatures, storage times, storage conditions, reconstitution fluids and procedures, and devices for product infusion, if any. The sponsor should inform all involved parties of these determinations.
• C. Acceptable storage temperatures and times
• D. Only infusion devices

Answer: (B)

Determining how to store the investigational product requires specifying all parameters that affect its stability and proper use: acceptable storage temperatures, storage times, storage conditions, reconstitution fluids and procedures, and any devices needed for product infusion, if applicable. The sponsor should communicate these determinations to all involved parties to ensure consistent handling, correct administration, and that product integrity is maintained from storage through to delivery to participants.

Options that focus only on temperatures, or only on devices, or only on temperatures and times, fail to cover the full set of requirements for proper storage and handling, which is why they aren’t sufficient.