Protocol Review and Monitoring System

项目总结：方案审查和监测系统 Shivaani Kummar，医学博士，临床和转化研究副总监 骑士癌症研究所（KCI）方案审查和监测系统（PRMS）支持开发 一个全面和科学相关的临床试验组合。PRMS确保癌症患者 获得设计科学合理、可及时完成、符合 联邦指导方针，值得优先考虑，并符合研究所的战略目标。有两 对所有临床试验进行科学审查的不同阶段。第一阶段包括临床研究疾病 第二阶段是KCI PRMS委员会。对拟议的试验进行初步审查 由DSG评估科学价值、与KCI和疾病现场目标的一致性、可用资源 包括相关患者人群、在规定时间内完成的可行性、竞争性试验， 并且符合疾病级别的组合。在该过程的第二阶段，PRMS审查 科学问题的合理性，设计的合理性，进行试验的可行性，以及试验满足 疾病试验组合中未满足的需求。符合条件的方案接受正式的科学进展评估 每年两次，对照目标监测应计费用，并对未达到目标的方案采取适当的纠正行动 应计目标。此外，对于五年以上开放累积的试验，重新评估科学相关性。的 PRMS全权制定科学进展评估决定。KCI临床工作人员 研究质量和管理小组为PRMS委员会提供行政支持， 独立于OHSU机构审查委员会（IRB）和KCI数据和安全性监查委员会 （DSMC）。

PROJECT SUMMARY: Protocol Review and Monitoring System Shivaani Kummar, M.D., Associate Director of Clinical and Translational Research The Knight Cancer Institute (KCI) Protocol Review and Monitoring System (PRMS) supports the development of a comprehensive and scientifically relevant portfolio of clinical trials. The PRMS ensures that cancer patients have access to clinical trials that are scientifically sound in design, feasible for timely completion, compliant with federal guidelines, deserving of priority, and in alignment with the strategic goals of the institute. There are two distinct stages of scientific review for all clinical trials. The first stage comprises the Clinical Research Disease Site Group (DSG), and the second stage is the KCI PRMS Committee. Proposed trials undergo an initial review by the DSG to assess scientific merit, alignment with the KCI and disease site goals, available resources including relevant patient population, feasibility for completion within the specified timeframe, competing trials, and fit within a disease-level portfolio. In the second stage of the process, the PRMS reviews for the relevance of the scientific question, soundness of the design, feasibility to conduct the trial, and ability of the trial to meet an unmet need within the disease trial portfolio. Eligible protocols undergo a formal scientific progress evaluation twice yearly to monitor accrual against the target with appropriate corrective actions for protocols that fail to meet accrual targets. In addition, scientific relevance is re-evaluated for trials open to accrual beyond five years. The PRMS has full authority to enact the scientific progress evaluation determination. Personnel in the KCI Clinical Research Quality and Administration group provide administrative support for the PRMS Committee, which acts independently of the OHSU Institutional Review Board (IRB) and the KCI Data and Safety Monitoring Committee (DSMC).