Which statement best describes the responsibility for ensuring the correct use of IP?

• A. The ethics committee oversees every administration.
• B. The sponsor ensures usage occurs but without training.
• C. The participant is solely responsible for correct use.
• D. The investigator is responsible for ensuring IP is used correctly per protocol.

Answer: (D)

The main idea is that the investigator holds the ultimate responsibility for the correct use of the investigational product in the trial. This means ensuring IP is stored, labeled, dispensed, and administered only to eligible participants and strictly according to the protocol and site SOPs. The investigator must also ensure appropriate training for the staff, maintain accurate IP accountability and handling records, and report any deviations or issues. The sponsor provides the IP, support, and monitoring, and may supply training, but the day-to-day use and compliance with protocol rest with the investigator. Ethics committees oversee participant protection and study ethics, not the specific handling of IP at the site. Therefore, the statement that the investigator is responsible for ensuring IP is used correctly per protocol best describes the situation.