A Monitoring Plan (MP) is a core trial oversight document that describes how monitoring will be performed to verify participant safety, protocol compliance, and data quality.
It defines monitoring strategy (on-site, remote, or risk-based), frequency, scope, and processes for issue escalation and follow-up. The MP outlines critical data and processes to focus on, including informed consent, eligibility, safety reporting, and endpoint documentation. A well-built plan aligns monitoring activities with protocol risks and supports consistent oversight across sites and regions. Clear monitoring expectations improve inspection readiness and help prevent recurring deviations through structured detection and correction.