What is the primary responsibility of a monitor?

• A. Draft the protocol.
• B. Verify subject safety and data accuracy.
• C. Recruit participants.
• D. Manage site budgets.

Answer: (B)

The monitor’s main job is to ensure subject safety and data accuracy. At trial sites, monitors verify that participants are protected—consent is properly obtained, eligibility is correct, and adverse events are reported promptly and handled according to the protocol. They also perform source data verification and cross-check study data against source documents to confirm accuracy and completeness, ensuring the trial data reliably reflect what actually happened. This combination protects participants while safeguarding the integrity and reliability of the trial results, which is the central purpose of monitoring.

Drafting the protocol is typically done by the sponsor or study designers, not the monitor. Recruiting participants is the responsibility of site staff or investigators, not the monitor. Managing site budgets falls under site management or finance, not monitoring.