Data and Safety Monitoring Committee (DSMC)

Policies and Procedures

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This document describes the structure and process by which the Data & Safety Monitoring Committee of the MU School of Medicine conducts reviews of protocol safety and progress. The structure and process are designed to protect the safety of human-research participants and to ensure the integrity and scientific validity of research data. The structure and process supports development and adoption of Data and Safety Monitoring Plans, monitoring data and serious adverse event reports, and making recommendations concerning the continuation of studies, including recommendations to modify, suspend, or terminate studies that pose undue risks to participants, present problematic conflicts of interest, or that apparently cannot be conducted successfully.

The structure and process described in this document, including the thresholds for establishing Data & Safety Monitoring Boards, are consistent with the NIH/NCI/FDA guidelines published as NIH Policy for Data and Safety Monitoring as of June 10, 1998, Policy of the NCI Data and Safety Monitoring of Clinical Trials as of June 22, 1999, Further Guidelines on a Data and Safety Monitoring Plan for Phase I and II Trials from the NIH on June 5, 2000, Guidelines for Clinical Trial Sponsors Establishment and Operation of Clinical Trial Data Monitoring Committees from the FDA in March, 2006.