What specific information should be documented in the records of investigational products?

• A. Only batch numbers.
• B. Only dates and quantities.
• C. Dates, quantities, batch/serial numbers, expiration dates, and unique code numbers assigned to the investigational products and trial participants.
• D. Only patient names.

Answer: (C)

Documentation of investigational products must capture the full trail of each product from receipt to administration and beyond, so there is clear accountability and traceability. The records should include dates of receipt and release, quantities, batch or serial numbers, expiration dates, and the unique code numbers assigned to both the investigational products and the trial participants. This combination lets you verify exactly what was given, when, and in what amount, while also supporting storage compliance, potential recalls, and proper blinding through coded identifiers. Recording only one element (like batch numbers, or dates and quantities, or patient names) misses essential information needed to track the product through the trial and protect participant confidentiality.