Clinical Protocol and Data Management Shared Resources

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All clinical oncology research at UTSW is coordinated by the Clinical Protocol and Data Management Shared Resource (Clinical Research Office; CRO). The CRO, along with the Protocol Review and Monitoring Committee (PRMC) and Data and Safety Monitoring Committee (DSMC), is part of the Protocol Review and Monitoring System (PRMS), which has direct oversight over all clinical oncology research activities at UTSW and the Cancer Center, and is responsible for oversight of all patient-related cancer research. Dr. Joan Schiller, Deputy Director of the Cancer Center, serves as Medical Director of the CRO. Ms. Lynn Baker, MBA, Assistant Director for Clinical Research, is the administrative director. The CRO serves as the clinical coordinating center for all activities related to clinical cancer research at UTSW. It provides infrastructure for oversight, management, and monitoring of oncology clinical trials, thus facilitating high quality clinical research throughout our campus. Centralization of these activities ensures standardization of all aspects of clinical research, ensuring patient safety and coordination of clinical research activities. The resource also provides a central location for cancer protocols, an updated list of currently active studies, status reports of protocols, and quality control and training for clinical research personnel and junior investigators. The CRO also provides administrative support for the PRMS and DSMC, including timely submission of all protocols, amendments, and regulatory documents; monitoring and auditing of SCC protocols to ensure compliance with all regulations; and accurate and timely submission of data to regulatory bodies. It assesses and assists with resource allocation, and standardizes operational policies and procedures.