Which action relates to the investigational product and is a monitor's responsibility?

• A. Ensuring the product is prepaid and invoices are correct
• B. Storing the product in personal offices
• C. Verifying that the investigational product(s) are supplied only to subjects who are eligible to receive it and at the protocol-specified dose
• D. Recommending changes to the protocol dosing without sponsor approval

Answer: (C)

The action being tested is the monitor’s duty to control that the investigational product is given only to subjects who are eligible and at the dose specified by the protocol. This keeps subject safety at the forefront and preserves the trial’s data integrity. A monitor verifies IP accountability by confirming subject eligibility before dispensing, ensuring the correct product and dose are provided, and recording every dispensation and dose. They also check that dispensing occurs through approved channels and that documentation aligns with the protocol, consent, and inclusion criteria. Proper handling, labeling, and tracing of the IP, plus ensuring deviations are documented, are all part of this responsibility.

Other options fall outside the monitor’s IP-specific scope. Prepaying IP invoices is administrative/vendor management work, not a monitoring activity focused on IP use. Storing the IP in personal offices breaches storage requirements and security controls. Recommending changes to protocol dosing without sponsor approval bypasses the established governance process and would require formal amendments.