PROTOCOL REVIEW AND MONITORING SYSTEMS

方案审查和监测委员会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（DLDCC）-附属机构。PRMC的功能是互补的 数据安全监查委员会和IRB的职责，但不重叠。的prm 回顾了所有主要目的与癌症相关的治疗和预防临床试验。的 PRMC分为一个执行委员会和三个工作组，共有45个投票权 成员执行委员会由PRMC主任Stacey贝格博士担任主席， 根据NIH审查描述符以及DLDCC优先级，制定1-9的科学价值评分方案 在初始评审时，对高、中、低评分，以帮助确定优先级。在每次开放的时候， 方案的年度IRB审查，PRMC执行委员会进行全面审查，以确保 取得了充分的科学进步。此外，执行委员会还审查 每个计划中的所有开放协议的应计费用。在12个月期间， 2008年7月至2009年6月，PMRC审查了50项新协议，包括10项机构协议， 其中6项批准待修改，3项提交，1项不批准。PMRC 在本报告所述期间监测了32项机构协议的执行情况， 因为新的科学信息降低了研究的优先级。PRMC提供报告， 临床研究领导委员会，该委员会还接收来自数据安全部门的报告 监督委员会确保这两个独立的工作组的活动得到整合。

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.