How should the investigational product(s) be stored?

• A. The investigational product(s) should be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s).
• B. Stored at any location as long as accessible.
• C. Stored only by sponsor's central warehouse.
• D. Storage not required to track.

Answer: (A)

IP storage must follow conditions defined by the sponsor and all applicable regulations to protect product quality, patient safety, and trial accountability. The sponsor specifies details like temperature range, light protection, humidity, packaging, labeling, and how the IP should be handled and documented. The site is responsible for keeping the IP in facilities that meet those conditions, with proper monitoring, validated equipment, controlled access, and complete records of storage conditions and any deviations. This ensures the IP remains stable from receipt through administration and allows accurate tracking of lot numbers, expiry dates, and inventory.

Storing IP wherever is convenient or without tracking undermines safety and compliance—deviations in storage can compromise potency or safety, and without proper records, you can’t confirm the IP used for a patient or audit the trial.