Which document confirms that investigational products have been used according to the protocol?

• A. To document IP used according to the protocol
• B. To track IP batch numbers
• C. To maintain consent forms
• D. To report to IRB

Answer: (A)

The key idea is having a clear, auditable record that shows exactly how the investigational product was used for each participant, in line with the protocol. The document that provides this confirmation is the IP administration log (drug accountability record), which records each dose given, the participant, date/time, dose, lot/batch number, and who administered it. This creates an uninterrupted trail showing adherence to the protocol and supports safety and regulatory review.

Tracking batch numbers is part of inventory control, not the per-dose usage confirmation. Maintaining consent forms relates to participant consent, not IP administration. Reporting to the IRB concerns oversight and safety reporting, not the day-to-day confirmation that IP was used as specified.