PROTOCOL REVIEW AND MONITORING SYSTEM (Core-016)

协议审查和监测系统（PRMS） 项目摘要 丹湖邓肯癌症中心（DLDCC）成立了方案审查和监测委员会 （PRMC）对所有癌症相关的科学和研究方面提供系统的内部监督。 在DLDCC附属机构进行的治疗和预防临床试验。由联合国开发计划署和DLDCC提供 根据政策，PRMC有权批准和关闭所有DLDCC临床研究方案。主持人：Stacey 贝格，医学博士，PRMC由一个执行委员会和三个工作组组成，共有44个成员 投票成员。PRMC根据标准NIH为每个协议分配1-9的科学价值评分 审查描述符。此外，还为援助协议分配了高、中或低的DLDCC优先级分数 优先化。已获得NCI癌症治疗评估项目（CTEP）批准的研究，或 癌症预防和控制协议审查委员会或由NIH资助的 作为供资进程一部分需要全面同行审议的机制， 审查. PRMC还监测积极研究的进展和累积。在每个开放协议的年度 IRB审查，或在认为必要时更频繁地进行审查，PRMC进行全面审查，以确保充分 科学正在进步。此外，PRMC还审查了每个项目中所有开放方案的应计费用， 按季度编制方案。PRMC与IRB以互补但不重复的方式运作 和数据安全监测委员会。PRMC向临床研究领导层提供报告 委员会，该委员会还接收数据安全性监查委员会的报告，从而确保 这两个独立的工作组的活动是一体化的。 从2011年到2013年，PRMC平均每年审查44份新提交的申请， 19个国家小组，3个其他外部同行审查，12个行业 赞助协议。每年还平均进行140次持续进展情况年度审查。

CORE: Protocol Review and Monitoring System (PRMS) PROJECT SUMMARY The Dan L. Duncan Cancer Center (DLDCC) has established the Protocol Review and Monitoring Committee (PRMC) to provide systematic internal oversight of the scientific and research aspects of all cancer-related therapeutic and prevention clinical trials conducted in DLDCC affiliated institutions. By BCM and DLDCC policy, the PRMC has authority to approve and close all DLDCC clinical research protocols. Chaired by Stacey Berg, M.D., the PRMC is organized into an Executive Committee and three working groups, with a total of 44 voting members. The PRMC assigns each protocol a scientific merit score of 1-9 according to standard NIH review descriptors. In addition, a DLDCC 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 (CTEP) 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. The PRMC also monitors progress and accrual of active studies. At the time of each open protocol’s annual IRB review, or more frequently if deemed necessary, the PRMC conducts a full review to ensure that adequate scientific progress is being made. In addition, the PRMC reviews the accrual to all the open protocols in each Program on a quarterly basis. The PRMC functions in a complementary but not duplicative way with the IRB and the Data Safety Monitoring Committees. The PRMC provides reports to the Clinical Research Leadership Committee, which also receives reports from the Data Safety Monitoring Committees, thus ensuring that activities of these two separate entitles are integrated. From 2011 to 2013, the PRMC reviewed an average of 44 new submissions per year, including 10 investigator-initiated institutional, 19 National Group, 3 other externally peer reviewed, and 12 industry sponsored protocols. An average of 140 annual reviews of ongoing progress were also performed each year.