Protocol Review and Monitoring System

项目摘要/摘要：协议审查和监测系统(PRMS) 进行癌症临床试验是亚利桑那癌症大学的科学使命的核心 中心(UACC)。开发和实施广泛的癌症试验组合需要 对科学、操作和患者资源的广泛机构承诺；因此，监督 试验组合的科学价值和进展对于确保试验结果有助于塑造 癌症防治的未来。对所有癌症试验的科学方面的内部监督 对癌症试验研究进展的监测由UACC议定书审查和 监控系统(PRMS)。科学审查委员会(SRC)是主要职能部门 PRMS的组成部分；它是特许的多学科机构，负责最终审查 UACC主要研究人员提出的所有癌症试验的科学价值、优先顺序和进展， 通过美国国立卫生研究院及其资助机构进行外部同行审查的试验除外。 SRC成员包括癌症治疗、癌症预防、 治疗发展，以及反映UACC临床试验广度的基础和人口科学 公文包。癌症试验是风险分层的，以确定是否需要全面委员会和行政管理 加快审查。有一个系统的程序来监测试验的应计费用和试验的科学性 进步。SRC有权终止没有达到预先指定的应计目标的试验或 没有达到他们的科学目标。PRMS绩效指标由临床生成 研究系统OnCore®，并为PRMS质量改进计划提供基础。

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.