DATA AND SAFETY MONITORING

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PROJECT SUMMARY The Winship Cancer Institute (Winship) is committed to maintaining high standards for data and safety monitoring of all clinical studies. To achieve this goal, Winship has developed a Data and Safety Monitoring Plan (DSMP) to ensure the following: the safety of all research participants; the ethical conduct of studies; and the achievement of scientific goals through high-quality data collection. An independent data and safety monitoring committee (DSMC) is charged with oversight of all investigator-Initiated and cooperative group trials. The DSMC includes physicians, research nurses, monitors, a statistician and a patient representative. This committee meets on a monthly basis to review ongoing studies, identify potential problems and assists investigators with developing appropriate corrective action plans. The DSMC is distinct and separate from the activities and management of the Clinical Trials Office and from the Clinical and Translational Review Committee which is an integral part of the Protocol Review and Monitoring System. The DSMC is led by one of Winship's outstanding clinical investigators, Suresh Ramalingam, M.D., associate professor of Hematology and Medical Oncology.