PROTOCOL REVIEW AND MONITORING SYSTEM (Core 012)

项目总结/摘要 USC Norris协议审查和监测系统（PRMS）有两个组织组成部分， 临床研究委员会（CIC）和科学进展和应计监测小组委员会。 在项目期间，PRMS得到了显著改进，从而缩短了周转时间， 减少低累积试验。CIC的成员现在代表了广泛的科学学科， 绝大多数是高级调查员。为了保证质量审查，我们明确了成员选择标准， 期限限制政策。我们亦增加了议会会议的次数和出席率， 科学审查和优先排序流程，改进与PI的书面沟通，并增加最大限度的 PI响应时间，以减少延迟。增加了一个新的业务和财务审查程序， 集成到PRMS工作流程中，以确保运营可行性，而不会增加周转时间。这些和 其他改进提高了初始科学审查过程的质量，并将PRMS的时间减半 批准，平均四周。加强对已批准试验的科学监测并结束试验 对于未能更快实现招生目标的学生，我们成立了专门的科学进步组织， 应计监测小组委员会。由此产生的结构完全分离的科学审查和质量 保证。随着这一组织变化，现有的应计监测政策得到加强，以便我们能够 关闭正在消耗机构资源且招募速度不合理的试验。总的来说， 目前的PRMS流程在选择和支持研究者发起的试验方面非常有效， 这些变化对质量和效率都产生了非常积极的影响。将实现更多的改进 随着OnCore的全面实施和长期成果的实现，

Project Summary/Abstract The USC Norris Protocol Review and Monitoring System (PRMS) has two organizational components, the Clinical Investigations Committee (CIC) and the Scientific Progress and Accrual Monitoring Subcommittee. During the project period, PRMS has been significantly improved, resulting in reduced turnaround time and fewer low accruing trials. Members of the CIC now represent a broad range of scientific disciplines and the clear majority is senior investigators. To assure quality reviews, we have clarified member selection criteria and term limit policies. We have also increased the frequency of CIC meetings and attendance rates, enhanced scientific review and prioritization processes, improved written communications with PIs, and added maximum PI response times to reduce delays. A new operational and financial review process has been added and integrated into the PRMS workflow to assure operational feasibility without increasing turnaround. These and other improvements have improved quality in the initial scientific review process and halved time to PRMS approval, which averages four weeks. To enhance scientific monitoring of approved trials and to close trials that are not achieving their enrollment targets more quickly, we formed a dedicated Scientific Progress and Accrual Monitoring Subcommittee. The resulting structure completely separates scientific review and quality assurance. With this organizational change, an existing accrual monitoring policy was tightened so that we can close trials that are consuming institutional resources and are not enrolling at a reasonable pace. In summary, the current PRMS process is highly effective in selecting and supporting investigator initiated trials and recent changes having a very positive impact on both quality and efficiency. Additional improvements will be achieved as OnCore is fully implemented and longer-term results are realized.