PROTOCOL REVIEW AND MONITORING SYSTEMS

议定书审查和监测委员会(PRMC)提供全面的科学审查和监测 所有涉及患者的癌症临床方案的进展和收益 丹·L邓肯癌症中心附属机构。PRMC的功能是互补的 至数据安全监察委员会和内部审查委员会，但不得重叠。PRMS 审查所有以癌症相关为主要目标的治疗和预防临床试验。这个 PRMC由一个执行委员会和三个工作组组成，共有45个投票权 会员。由PRMC主任Stacey Berg博士担任主席的执行委员会分配每个 根据NIH审查描述符以及DLDCC优先级的1-9的科学功绩评分 初始评审时的高、中、低分数有助于确定优先顺序。在每次开业时 作为礼宾委员会的年度内部审查委员会，临立会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，执行委员会还审查了 按季度计入每个计划中的所有开放协议。在12个月内， 2008年7月至2009年6月，PMRC审查了50项新议定书，其中包括10项机构议定书 其中6个被批准等待修改，3个被提交，1个被否决。临市政署 在此期间对32个机构协议进行监控，以完成3项缓慢应计或 因为新的科学信息降低了研究的优先顺序。PRMC向以下人员提供报告 临床研究领导委员会也接受数据安全局的报告 监督委员会，确保这两个独立实体的活动相结合。

The Protocol Review and Monitoring Committee (PRMC) provides full scientific review and monitors the progress of and accrual to all cancer clinical protocols Involving patients that are conducted in Dan L Duncan Cancer Center (DLDCC)-affiliated Institutions. PRMC functions are complementary to, but do not overlap those of the Data Safety Monitoring Committee and the IRB. The PRMS reviews all therapeutic and prevention clinical trials whose primary aim Is cancer related. The PRMC Is organized Into an Executive Committee and three working groups, with a total of 45 voting members. The Executive Committee chaired by Dr Stacey Berg the PRMC director assigns each protocol a scientific merit score of 1-9 based on NIH review descriptors as well as DLDCC priority scores of High, Medium, and Low at initial review to aid In prioritization. At the time of each open protocol's annual IRB review, the PRMC 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 the open protocols in each Program on a quarterly basis. In the 12 month period from July 2008 to June 2009 the PMRC reviewed 50 new protocols including 10 institutional protocols of which 6 were approved pending modification, 3 were tabled, and 1 was disapproved. The PMRC monitored 32 Institutional protocols during this period for performance closing 3 for slow accrual or because new scientific information lowered the priority of the study. The PRMC provides reports to the Clinical Research Leadership Committee which also receives reports from the Data Safety Monitoring Committees ensuring that activities of these two separate entitles are integrated.