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 modification, suspension, or closure based on safety or regulatory concerns. Recommendations for trial suspension or closure are implemented through the Deputy Director of the Cancer Center and the IRB. The essential functions of the DSMC include: * Review and tracking of all SAE's reported for cancer-related trials. * Full committee review of selected adverse events. * Annual systematic review of all institutional therapeutic trials. * Independent evaluation of treatment responses. * Investigation of potential regulatory compliance violations. * Weekly monitoring of toxicities and systematic review of all first accruals to Phase I trials. * Comprehensive documentation auditing for 10% of all cancer-related clinical trials. * Serves as the DSMC for any therapeutic trial lacking a DSMC. The DSMC membership consists of a Chairperson and Co-Chairperson, and representation from biostatistics, nursing, regulatory, pharmacy, and faculty. Faculty members are selected from all the oncology treatment modalities (Surgery, Radiation Oncology and Medical Oncology). A DSMC Coordinator provides administrative support for all of the DSMC activities and a Quality Assurance &Education Coordinator conducts the internal audits.
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