PROTOCOL REVIEW AND MONITORING SYSTEM (Core-016)

核心：协议审查和监测系统(PRMS) 项目总结 丹·L·邓肯癌症中心(DLDCC)成立了礼宾审查和监测委员会 (PRMC)对所有与癌症有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BCM和DLDCC提供 政策，PRMC有权批准和关闭所有DLDCC临床研究方案。由Stacey担任主席 PRMC由一个执行委员会和三个工作组组成，共有44个工作组 有投票权的成员。根据美国国立卫生研究院的标准，PRMC为每个方案分配了1-9的科学价值分数 查看描述符。此外，将高、中或低的DLDCC优先级分数分配给AID协议 确定优先顺序。NCI癌症治疗评估计划(CTEP)批准的研究或 癌症预防和控制方案审查委员会或由NIH资助的 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。 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会议上 内部审查委员会进行全面审查，或在认为必要时进行更频繁的审查，以确保足够的 科学进步正在取得。此外，PRMC审查每个协议中所有开放协议的应计费用 计划在季度的基础上。PRMC的功能与IRB相辅相成，但不是重复的 和数据安全监控委员会。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监测委员会的报告，从而确保 这两个独立权利人的活动是综合的。 从2011年到2013年，PRMC平均每年审查44份新提交的材料，其中包括10份 调查员发起的机构，19个国家集团，3个其他外部同行审查，12个行业 赞助协议。每年还平均对正在进行的进展情况进行140次年度审查。

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.