PROTOCOL REVIEW AND MONITORING SYSTEM (Core-010)

Harold C.西蒙斯癌症中心 方案审查和监测系统（PRMS） 项目总结/摘要 方案审查和监测系统（PRMS）的目标是确保最高的科学质量， 临床肿瘤学研究，包括三个癌症中心的方案审查和监测 委员会（PRMC）、数据和安全性监查委员会（DSMC）以及行政支持 临床研究办公室的服务。这些实体由临床癌症研究所监督。 该委员会向癌症中心副主任报告。SCC有三个PRMC;两个“一般” 每个委员会每月举行一次会议，一个委员会专门负责人口研究。PRMC 1和PRMC 2 职责相同，但会议日期错开，以便更及时地 审查和批准新方案。人口科学PRMC负责与以下方面有关的协议： 人口科学和癌症控制。 三个PRMC在IRB审查之前审查和监测所有癌症相关临床研究的科学价值。 PRMC有权开放符合科学价值和科学优先事项的协议， SCC，并关闭不证明科学进步的协议。PRMC的重点是 科学价值、研究优先次序和癌症中心临床试验的进展。研究已经 在国家一级进行了严格的同行审查，如国家合作研究所批准的国家合作小组研究 由PRMC主席进行行政审查。

Harold C. Simmons Cancer Center Protocol Review and Monitoring System (PRMS) Project Summary/Abstract The goal of the Protocol Review and Monitoring System (PRMS) is to ensure the highest scientific quality of clinical oncology research at UTSW and consists of three Cancer Center Protocol Review and Monitoring Committees (PRMCs), the Data and Safety Monitoring Committee (DSMC), and the administrative support services of the Clinical Research Office. These entities are overseen by the Clinical Cancer Research Committee, which reports to the Cancer Center's Deputy Director. The SCC has three PRMCs; two “general” committees, each of which meets monthly, and one reserved for Population Studies. PRMC1 and PRMC2 have the same responsibilities, but were created with staggered meeting dates so as to allow more timely review and approval of new protocols. The Population Sciences PRMC is responsible for protocols related to Population Sciences and Cancer Control. The three PRMCs review and monitor all cancer-related clinical studies for scientific merit prior to IRB review. The PRMCs have the authority to open protocols that meet the scientific merit and scientific priorities of the SCC, and to close protocols that do not demonstrate scientific progress. The focus of the PRMCs is on scientific merit, study prioritization, and progress of Cancer Center clinical trials. Studies which have already undergone rigorous peer review at the national level, such as NCI-approved national cooperative group studies are reviewed administratively by the PRMC Chair.