What should be signed to confirm agreement to the protocol?

• A. The protocol, or an alternative contract, to confirm agreement.
• B. Consent forms.
• C. Budget agreement.
• D. Non-disclosure agreement.

Answer: (A)

Signing the protocol (or an alternative contract that references the protocol) confirms that the site and investigator agree to conduct the study exactly as described. This formal signature binds all parties to the study design, procedures, eligibility criteria, and safety reporting requirements before the trial starts. Consent forms are for participants’ informed consent, not for agreeing to the protocol; budget agreements cover funding, and non-disclosure agreements cover confidentiality. Therefore, the protocol or a contract tied to it is the correct mechanism to confirm agreement to the protocol.