Human Subjects Research Monitoring Report (IRB)
by Ashleigh Ruehrdanz, from the Community
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.
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This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.