Which document is used to document the financial agreement between the investigator/institution and the sponsor for the trial?

• A. Financial Aspects of the Trial
• B. Investigator's Brochure
• C. Advertisement for Subject Recruitment
• D. Informed Consent Form

Answer: (C)

The key idea is how the sponsor and the investigator/institution formalize the money side of the trial. The document that records the financial agreement, including funding amounts, payment terms, budgets, and responsibilities for costs, is the Financial Aspects of the Trial. It sets out how and when the site will be compensated, what costs are covered, and what conditions must be met before payments are made, helping prevent misunderstandings before the study begins.

The Investigator’s Brochure is a reference document for investigators about the investigational product’s safety and trial data, not about finances. An advertisement for subject recruitment is used to recruit participants and has nothing to do with financial terms. The Informed Consent Form explains the trial to participants and obtains their voluntary agreement to participate, not the financial arrangement between sponsor and site.