Protocol Review and Monitoring System

项目总结：方案审查和监测系统（PRMS） 一个单一的方案审查和监测系统（PRMS）管理所有肿瘤学临床试验方案， 该联盟与机构合作，并确保与癌症相关的人类研究是（1）科学的 （2）设计适当，不排除非特定人群， 科学理由;（3）可行，考虑到现有患者人群，可合理实现应计目标; （4）支持联合体的研究使命。PRMS的核心特征是科学的 审查委员会（SRC）。PRMS委员会结构负责批准符合其 严格和明确的标准。在提交给SRC之前，需要进行研究小组审查， 作为两阶段审查过程的一部分，并确保联合体协议具有很高的科学价值， 在为发展投入更多的机构资源之前，这是可行的。 SRC评估所有联盟临床试验的科学价值、可行性、优先顺序和进展 协议.作为联合体试验启动过程的一部分，IRB审查前需要SRC批准。 高效的运营和每周的SRC会议使总流程时间中位数达到14个日历 日（10个工作日），自2015年以来一直保持不变。PRMS进一步确保在 应计，方案的科学依据仍然具有相关性，应计足以满足 审判的科学目的。自2015财年实施更新后的低计提政策以来， 审查和结案数量从25项审查和3项结案增加到2005财政年度的74项审查和24项结案 2018. PRMS批准的所有协议都可以访问CCSG支持的集中资源，包括 临床方案和数据管理（CPDM）以及生物统计学共享资源（BSR）。PRMS具有 最终有权关闭不显示科学进步的试验。

PROJECT SUMMARY: PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) A single Protocol Review and Monitoring System (PRMS) governs all oncology clinical trial protocols across the Consortium partner institutions and assures that cancer-relevant human research is (1) scientifically important and statistically sound; (2) designed appropriately without excluding special populations for non- scientific reason; (3) feasible, with reasonably attainable accrual targets given the available patient population; and (4) supportive of the research mission of the Consortium. The central feature of the PRMS is the Scientific Review Committee (SRC). The PRMS committee structure is responsible for approving protocols that meet its stringent and well-defined criteria. A Research Group Review is required prior to submission to the SRC as part of a two-stage review process and assures that Consortium protocols are of high scientific merit and feasible prior to investing additional institutional resources in development. The SRC evaluates scientific merit, feasibility, prioritization, and progress of all Consortium clinical trial protocols. As part of the Consortium’s trial activation process, SRC approval is required prior to IRB review. Efficient operations and weekly SRC meetings have resulted in a median overall process time of 14 calendar days (10 business days) which has remained consistent since 2015. The PRMS further ensures that during accrual, the scientific rationale for the protocol has remained relevant and that accrual is sufficient to meet the scientific aims of the trial. Since implementation of the updated Low Accrual Policy in FY 2015, the number of reviews and closures increased from 25 trials reviewed and three closures, to 74 reviewed and 24 closed in FY 2018. All protocols approved by PRMS have access to CCSG-supported centralized resources, including Clinical Protocol and Data Management (CPDM) and the Biostatistics Shared Resource (BSR). PRMS has the ultimate authority to close trials that do not demonstrate scientific progress.