Where should the financial aspects of the trial be documented?

• A. In an agreement between sponsor and investigator/institution.
• B. In the protocol.
• C. In the consent form.
• D. In the data management plan.

Answer: (A)

The financial terms and obligations for a trial should be documented in the agreement between the sponsor and the investigator/institution. This contract formalizes funding, payment schedules, responsibilities, and terms for oversight, audits, and termination, helping ensure proper budgeting, accountability, and compliance with GCP and regulatory requirements. The protocol describes how the study is conducted, the consent form informs participants about participation, and the data management plan covers data handling aspects; none of these are the appropriate place for the sponsor–site financial terms.