What must investigators maintain to demonstrate that subjects were provided the doses specified by the protocol and to reconcile all investigational product(s) received from the sponsor?

• A. Records that subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.
• B. Only records of deliveries.
• C. Only patient consent records.
• D. No records required.

Answer: (B)

The key idea is IP accountability: you must keep a complete, traceable record that links what the sponsor ships to the site with what is actually given to subjects and how that IP is reconciled at the end. Maintaining records that show each subject was provided the doses specified by the protocol, along with a reconciliation of all IP received from the sponsor, creates an auditable trail. It demonstrates that dosing stayed within the protocol and that inventory was accounted for—no discrepancies left unexplained. Simply keeping records of deliveries does not prove that the correct doses were administered to subjects or that all IP was properly reconciled and accounted for. Consent records, while important for ethical participation, do not substitute for IP accountability, and having no records at all would be a serious compliance violation.