What document records site visits by, and findings of, the monitor?

• A. Monitoring Visit Reports
• B. Source Documents
• C. Informed Consent Forms
• D. Certificates of Analysis

Answer: (A)

The key idea is that a monitor’s observations and conclusions from a site visit are recorded in a dedicated monitoring document. A Monitoring Visit Report captures when the visit happened, what was reviewed, who was present, and the findings about protocol compliance and data quality. It lists any deviations or problems, notes potential risks to subject safety or study integrity, and outlines corrective actions with timelines and follow-up plans. This report becomes part of the trial master file and serves as the official record used by sponsors, investigators, and auditors to track site performance and ensure proper oversight. Other documents mentioned serve different purposes: source documents are the original data entries for participants, informed consent forms document participant consent, and certificates of analysis verify the quality of materials but do not document monitoring visits or findings.