Protocol Review and Monitoring System

议定书审查和监测系统(PRMS)项目摘要 贝勒医学院丹·L·邓肯综合癌症中心(DLDCCC)已经 设立了礼宾审查和监测委员会(PRMC)，以提供系统的内部监督 DLDCCC所有介入癌症临床方案的科学和研究方面 机构设施。根据BCM和DLDCCC政策，PRMC有权批准和关闭所有DLDCCC 临床研究方案。PRMC由医学博士Stacey Berg担任主席，并组成一个执行委员会 3个工作组，共49人。PRMC为每个协议分配一个科学的优点分数 1-9根据标准的NIH审查描述。此外，DLDCCC优先级分数为高、中或低 被分配来帮助确定协议的优先级。NCI癌症治疗评估批准的研究 项目或癌症预防和控制方案审查委员会，或由NIH资金支持的 要求在筹资过程中进行全面同行审查的机制需要加快行政程序 复习一下。此外，对于多地点机构试验，议定书可能有资格在以下情况下进行加速的PRMC审查 BCM不是铅站点，并且该铅站点的经批准的PRMS已对 协议。 PRMC还监测积极研究的进展和累积情况。在每个开放协议的年度IRB会议上 如果认为有必要，执行委员会进行全面审查，以确保 目前正在取得足够的科学进展。此外，执行委员会审查了所有未结案的应计项目。 每个计划中的协议每季度一次。应计费用持续滞后的议定书将被关闭 其科学目标可能被该领域的发展所取代的议定书也是如此。 PRMC审查是对IRB或数据安全监控委员会审查的补充，但不会重复。 2016年至2018年，预委会平均每年审查提交的新意见，其中包括10个DLDCCC 调查人员发起的机构，27个国家集团，2个其他外部同行审查，17个行业- 赞助协议。此外，平均每年进行226次进度审查和27次修正案审查 也进行了表演。

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) PROJECT SUMMARY The Dan L. Duncan Comprehensive Cancer Center (DLDCCC) at Baylor College of Medicine (BCM) has established the Protocol Review and Monitoring Committee (PRMC) to provide systematic internal oversight of the scientific and research aspects of all interventional cancer clinical protocols conducted in DLDCCC institutional facilities. By BCM and DLDCCC policy, the PRMC has authority to approve and close all DLDCCC clinical research protocols. Chaired by Stacey Berg, MD, the PRMC is organized into an Executive Committee and 3 Working Groups, with a total of 49 members. The PRMC assigns each protocol a scientific merit score of 1–9 according to standard NIH review descriptors. In addition, a DLDCCC priority score of High, Medium, or Low is assigned to aid protocol prioritization. Studies that have been approved by the NCI Cancer Therapy Evaluation Program or Cancer Prevention and Control Protocol Review Committee, or that are supported by an NIH funding mechanism that required full peer review as part of the funding process undergo an expedited administrative review. In addition, for multi-site institutional trials, the protocol may be eligible for expedited PRMC review if BCM is not the lead site and the approved PRMS of the lead site has performed full scientific review of the protocol. The PRMC also monitors progress and accrual of active studies. At the time of each open protocol's annual IRB review or more often if deemed necessary, the Executive Committee conducts a full review to ensure that adequate scientific progress is being made. In addition, the Executive Committee reviews the accrual to all open protocols in each Program on a quarterly basis. Protocols whose accrual continues to lag are subject to closure by the PRMC, as are protocols whose scientific goals may have been superseded by developments in the field. PRMC review complements, but does not duplicate, IRB or Data Safety Monitoring Committee review. From 2016 to 2018, the PRMC reviewed an average of 64 new submissions per year, including 10 DLDCCC investigator-initiated institutional, 27 National Group, 2 other externally peer reviewed, and 17 industry- sponsored protocols. In addition, an average of 226 progress reviews and 27 amendment reviews per year were also performed.