CORE--Protocol Review

方案审查和监测系统(PRMS)的任务是对在OHSU癌症研究所(CI)进行的所有癌症临床试验提供内部监督，以确保在临床研究过程中对受试者的科学完整性和保护。PRMS包括初步科学方案审查、对方案活动的实时监测、每月累积报告审查、年度审查和最终审查。全 癌症研究所PRMS的组成部分由临床研究审查委员会(CRRC)负责。CI主任要求CRRC确保在该研究所进行的所有临床试验和与癌症相关的研究：1)具有科学价值；2)经过适当的设计和统计验证；3)在指定的时间框架内完成是可行的；4)符合FDA和NIH的临床试验指南；以及5)与研究所的优先事项、目标和利益相一致。中国中车的职能包括 独立于OHSU机构审查委员会(IRB)和数据与安全监测委员会(DSMC)。中国中车的主席是克雷格·尼科尔斯医学博士。临床研究管理总监玛格丽特·麦克马洪·MN ANP是CRRC的联合主席和管理PRMS的人。

The mission of the Protocol Review and Monitoring System (PRMS) is to provide internal oversight of all cancer clinical trials conducted at the OHSU Cancer Institute (CI) to ensure both scientific integrity and the protection of human subjects through the course of the clinical research process. The PRMS includes initial scientific protocol review, real-time monitoring of protocol activity, monthly cumulative report review, annual review and final review. All components of the PRMS at the Cancer Institute are the responsibility of the Clinical Research Review Committee (CRRC). The CRRC is charged by the CI Director to ensure that all clinical trials and cancer-related research conducted at the Institute are: 1) scientifically meritorious; 2) appropriately designed and statistically validated; 3) feasible for completion within the specified time frame; 4) in compliance with FDA and NIH guidelines for clinical trials; and, 5) compatible with the priorities, goals, and interests of the Institute. The functions of the CRRC are independent of the OHSU Institutional Review Board (IRB) and the Data and Safety Monitoring Committee (DSMC). The CRRC Chair is Craig Nichols MD. The Director of Clinical Research Management, Margaret McMahon MN ANP, is CRRC co-chair and administers the PRMS.