What are the purposes of trial monitoring?

• A. The rights and well-being of subjects are protected; the reported trial data are accurate, complete, and verifiable from source documents; the conduct of the trial is in compliance with the currently approved protocol/amendment(s), GCP, and applicable regulatory requirement(s)
• B. To maximize sponsor profits
• C. To recruit more sites
• D. To minimize subject safety

Answer: (A)

Monitoring in clinical trials aims to protect participants, ensure the accuracy and reliability of the data, and confirm that the study is conducted in line with the approved protocol, GCP, and applicable regulations. This means safeguarding the rights, safety, and well-being of subjects; ensuring that the reported trial data are accurate, complete, and verifiable from source documents; and verifying compliance with the protocol and regulatory requirements. These elements together maintain participant protection and data integrity, which are essential for ethical and credible research. The other options don’t reflect the purpose of monitoring: profit, expanding sites, or reducing safety would undermine the trial’s integrity and ethics.