PROTOCOL REVIEW AND MONITORING SYSTEM (Core 012)

项目总结/文摘

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.