Who performs monitoring?

• A. Central IRB.
• B. Study participants.
• C. Sponsor or sponsor designee.
• D. Principal Investigator only.

Answer: (C)

Monitoring is the process of overseeing trial progress, data quality, and participant safety to ensure the study runs according to the protocol and regulatory requirements. The sponsor bears the primary responsibility for this function and may delegate it to a designee, such as a contract research organization or independent monitors. These monitors conduct on-site visits or centralized reviews to verify protocol compliance, consent procedures, adverse event reporting, data accuracy, and documentation.

The central IRB oversees ethical aspects and participant protections but does not perform routine trial monitoring. The principal investigator is responsible for conduct at the site and working with monitors, but the formal monitoring activities across the study are carried out by the sponsor or their designee. Participants themselves do not monitor the trial.