A Routine Monitoring Visit (RMV) is a periodic review of a clinical research site conducted during an active clinical trial to assess study conduct, protocol compliance, data quality, and participant safety. RMVs are typically performed by a clinical research associate (CRA) on behalf of a sponsor or contract research organization (CRO) as part of the trial’s monitoring activities.
During an RMV, the monitor may review informed consent documentation, source records and study data, protocol deviations, investigational product accountability, regulatory documentation, safety reporting, participant enrollment, and other study-related activities. The visit also provides an opportunity to identify and address issues, answer site questions, and confirm that study personnel are following the protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.
Routine monitoring visits help sponsors maintain oversight throughout a clinical trial, identify potential risks or compliance concerns, and support accurate, complete, and reliable study data. Effective monitoring ultimately contributes to protecting research participants and maintaining the quality and integrity of clinical research