Which items should be included in the investigational product accountability records?

• A. Dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product(s) and trial subjects.
• B. Dates and quantities only.
• C. Batch/serial numbers and expiration dates only.
• D. Unique code numbers.

Answer: (C)

IP accountability records must provide an auditable trail of receipt, dispensation, and disposition of the investigational product. To ensure traceability, these records should include dates of receipt and handling, the quantities involved, batch or serial numbers to identify the specific product, expiration dates when applicable to confirm the product is within shelf life, and the unique code numbers assigned to the investigational product and to the trial subjects so each dispensed unit can be linked to the correct participant while protecting confidentiality. Without dates and quantities you can’t verify inventory and dosing; without batch/serial numbers you can’t identify which product was used; without expiration dates you risk using an expired product; without unique codes you lose proper linkage and confidentiality.