PROTOCOL REVIEW AND MONITORING SYSTEM (Core 012)

项目摘要/摘要 南加州大学诺里斯协议审查和监测系统(PRMS)有两个组织组件，即 临床研究委员会(CIC)和科学进步和累积监测小组委员会。 在项目期间，PRMS得到了显著改进，从而缩短了周转时间，并 较少的低累积率试验。CIC的成员现在代表了广泛的科学学科和 显然，大多数是高级调查人员。为了确保评审的质量，我们明确了成员的遴选标准和 任期限制政策。我们还增加了CIC会议的频率和出席率，增强了 科学的审查和优先顺序流程，改进与绩效指标的书面沟通，并增加最大 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，并 整合到PRMS工作流程中，在不增加周转的情况下确保运营可行性。这些和 其他改进提高了最初科学审查过程的质量，并将PRMS的时间减半 批准，平均需要四周。加强对已批准试验的科学监测并结束试验 他们没有更快地实现他们的招生目标，我们成立了一个专门的科学进步和 应计项目监测小组委员会。由此产生的结构完全分离了科学审查和质量 保证。随着这一组织变革，现有的应计项目监测政策得到收紧，以便我们能够 正在消耗机构资源并且没有以合理的速度登记的封闭试验。总而言之， 目前的PRMS流程在选择和支持研究人员发起的试验和最近的 对质量和效率都有非常积极影响的变化。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.