The monitor's responsibilities include ensuring that the trial is conducted and documented properly by carrying out activities when relevant. This is described in which section?

• A. The monitoring plan
• B. The Investigational Brochure
• C. The sponsor's contract
• D. The site budget

Answer: (A)

Monitoring activities and how they ensure proper conduct and documentation are defined in the monitoring plan. This plan specifies what monitors do, how often they verify source data, ensure protocol adherence, and check that essential documents are complete and compliant, including the steps for visits, remote checks, and any corrective actions. The Investigational Brochure provides background about the investigational product and does not lay out monitoring procedures. The sponsor’s contract outlines obligations between sponsor and sites, not the day-to-day monitoring steps. The site budget deals with financial aspects, not monitoring duties. So the section that describes the monitor’s responsibilities and the activities they perform is the monitoring plan.