Data and Safety Monitoring

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The Data and Safety Monitoring System at the University of Texas Southwestern Medical Center (UTSW) Simmons Cancer Center is designed to ensure patient safety and data quality for cancer-related clinical trials. The Data and Safety Monitoring Committee (DSMC) is an independent committee appointed by the Deputy Director of the Cancer Center and is responsible for carrying out the data and safety monitoring plan for the Cancer Center. The DSMC can recommend trial modificafion, suspension, or closure based on safety or regulatory concerns. Recommendafions for trial suspension or closure are implemented through the Deputy Director of the Cancer Center and the IRB. The essenfial funcfions of the DSMC include: Review and tracking of all SAE's reported for cancer-related trials. Full committee review of selected adverse events. Annual systemafic review of all institufional therapeufic trials. Independent evaluation of treatment responses. Invesfigation of potential regulatory compliance violations. Weekly monitoring of toxicities and systematic review of all first accruals to Phase I trials. Comprehensive documentafion auditing for 10% of all cancer-related clinical trials. Serves as the DSMC for any therapeufic trial lacking a DSMC. The DSMC membership consists of a Chairperson and Co-Chairperson, and representation from biostafistics, nursing, regulatory, pharmacy, and faculty. Faculty members are selected from all the oncology treatment modalifies (Surgery, Radiation Oncology and Medical Oncology). A DSMC Coordinator provides administrative support for all of the DSMC activifies and a Quality Assurance & Educafion Coordinator conducts the internal audits.