Protocol Review and Monitoring System

项目摘要/摘要：协议审查与监测系统（PRMS）

Project Summary / Abstract: Protocol Review and Monitoring System (PRMS) The conduct of cancer clinical trials is central to the scientific mission of the University of Arizona Cancer Center (UACC). The development and implementation of a broad portfolio of cancer trials requires an extensive institutional commitment of scientific, operational, and patient resources; thus, oversight of the scientific merit and progress of the trial portfolio is paramount in ensuring that trial outcomes help shape the future of cancer prevention and treatment. The internal oversight of the scientific aspects of all cancer trials and the monitoring of the progress of cancer trials research is managed by the UACC Protocol Review and Monitoring System (PRMS). The Scientific Review Committee (SRC) serves as the principal functional component of the PRMS; it is the chartered, multidisciplinary body charged with the ultimate review of the scientific merit, prioritization, and progress of all cancer trials proposed by UACC Principal Investigators, with the exception of those trials that have undergone external peer-review through NIH and its funding agencies. The SRC membership is composed of a broad spectrum of specialists in cancer treatment, cancer prevention, therapeutic development, and basic and population science that mirrors the breadth of the UACC's clinical trial portfolio. Cancer trials are risk-stratified for determination of need for full Committee versus administrative expedited review. A systematic process is in place for the monitoring of accrual to trials and of trial scientific progress. The SRC has the authority to terminate trials that have not met pre-specified accrual targets or that are not meeting their scientific objectives. The PRMS performance metrics are generated by the clinical research system OnCore® and provide the basis for PRMS quality improvement initiatives.