Human Subjects Research Monitoring Report (IRB)

Use this IRB monitoring report template to evaluate human subjects research protocols under expedited or full board oversight. Capture study information (title, IRBNet number, PI and faculty sponsor), monitoring details, and records/data management practices, including storage locations, access controls, and consent form handling. Review recruitment procedures, privacy protections, and the informed consent process, including versions, minors, and waivers. Verify eligibility criteria, source documentation, and training records. Record adverse events, unanticipated problems, and protocol deviations with reporting status. Audit the study file and IRB documentation for continuing review, expiration dates, and lapsed periods. Conclude with findings, recommendations, and follow-up actions.