Data and Safety Monitoring System

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The Data and Safety Monitoring function of the ID Simon Cancer Center is the primary responsibility of the Clinical Trials Monitoring Committee (CTMC). Its function is closely related to the Scientific Review Committee, which evaluates the scientific merit of all cancer-related clinical trials of the Center. The IUSCC Clinical Trials Monitoring Committee (CTMC) is chaired by Dr. Romnee Clark. The primary responsibilities of the CTMC are to assess the adequacy of trial-specific data safety monitoring plans (DMSP's) for each protocol reviewed by the SRC, to review ILJSCC-sponsored studies for patient safety, to ensure protocol and adverse event report compliance, and to conduct internal audits and quality assurance reviews. The Clinical Research Committee (CRC) chaired by Dr. Kathy Miller, Interim Associate Director for Clinical Research, oversees the policies and procedures of the SRC and CTMC, receives monthly reports of the activities of these committees, and arbitrates in the event of disputes.