Protocol Review and Monitoring System

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The goal of the Protocol Review and Monitoring System (PRMS) is to ensure the highest scientific quality and patient safety for individuals going on clinical cancer studies at UTSW. The Simmons Cancer Center PRMC consists of the Protocol Review and Monitoring Committee (PRMC), the Data and Safety Monitoring Committee (DSMC), and the administrafive support services of the Clinical Research Office Shared Resource (CRO). These three entifies are overseen by the Clinical Cancer Research Committee (CCRC), which aids the Deputy Director in overseeing all clinical research activities conducted at the Cancer Center, recommends new policies and procedures to the Deputy Director, and identifies scienfific priorities and clinical issues in the cancer center. The CCRC is chaired by the Deputy Director, and co-chaired by the Associate Director for Clinical Research. The PRMC reviews and monitors all cancer-related clinical studies for scientific merit. In addition, it is responsible for overseeing the scientific progress of open clinical trials by monitoring accrual to all SCCC protocols. The PRMC is chaired by Dr. Hak Choy, Professor and Chair of Radiafion Oncology, and co-chaired by Dr. Chul Ahn, Professor of Biostafisfics. Members are appointed by the Cancer Center Deputy Director and represent the expertise necessary to provide high-level clinical oncology protocol reviews and monitoring of those which receive committee approval. All UTSW clinical trials involving cancer pafients must receive PRMC approval before the IRB will schedule it for review. The DSMC is designed to ensure pafient safety and data quality for cancer-related clinical trials. The DSMC is an independent committee appointed by the Deputy Director of the Cancer Center and chaired by Dr. David Euhus, Associate Director for Clinical Research, and is responsible for carrying out the data and safety monitoring plan for the Cancer Center. The CRO is headed by Ms. Lynn Baker, Assistant Director for Clinical Research, and is responsible for inifiafing, implemenfing, and conducfing clinical research protocols in the Cancer Center. The CRO staff includes clinical research coordinafing personnel, as well as staff that provide regulatory and operafional support.