The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm agreement. What action confirms agreement?

• A. Submitting the protocol to IRB
• B. Retaining the trial records
• C. Signing the protocol, or an alternative document
• D. Providing the Investigator's Brochure

Answer: (C)

Signing the protocol (or an alternative document) is the action that confirms agreement. When both sponsor and investigator sign, they formally acknowledge and accept the study plan, their respective roles, responsibilities, and the procedures to be followed. This signed agreement creates a binding commitment to conduct the trial as outlined in the protocol.

Submitting the protocol to the IRB is for ethics review, not a mutual agreement to conduct the study. Retaining trial records is about keeping documentation for compliance and traceability, not signaling agreement. Providing the Investigator’s Brochure shares information about the product; it does not certify that sponsor and investigator have agreed to run the trial.