Which activity is a monitor's responsibility to ensure the trial is conducted and documented properly?

• A. Verifying that the investigator follows the approved protocol and all amendments
• B. Providing direct medical care to trial subjects
• C. Handling sponsor financial reporting
• D. Auditing the trial staff's personal nutrition

Answer: (A)

Ensuring protocol adherence and proper documentation is the monitor's primary responsibility. The monitor verifies that the investigator follows the approved protocol and any amendments, reviews source documents and consent forms, and ensures that essential trial documents are complete and accurate so the study complies with GCP and regulatory requirements. Providing direct medical care to subjects is not the monitor’s role; that is the investigator’s responsibility. Sponsor financial reporting and unrelated tasks like auditing staff nutrition do not fall under the monitor’s duties.