Protocol Review and Monitoring System

项目摘要 方案审查和监测系统（PRMS）的总体使命是确保斯坦福大学癌症研究中心 研究所（SCI）的研究人员执行的临床研究是科学上有价值的，精心设计的， 分布在广泛的癌症学科中，并且可行。SCI科学评论 委员会（SRC）和以疾病或方式为导向的临床研究小组（CRG）共同履行 PRMS负责SCI和斯坦福大学内的癌症相关临床研究。CRG进行 癌症相关临床试验的选择和优先顺序的第一阶段，SRC进行 第二阶段。SRC拥有批准研究的最终权力，确保所有与癌症相关的临床试验 在SCI进行的研究具有最高的科学价值，与SCI的优先事项一致，并且可行， 行为。在CCSG周期内，SRC平均每年审查140项新研究。初始SRC 在整个资助期间，61%的研究审查决定获得批准，24%需要答复，13%提交 2%被拒绝。平均每年审查116项研究，以了解科学进展。 SRC负责研究的常规科学进展审查，并有权暂停或 由于低累积、停止违反规则、科学相关性或其他科学- 基于或基于合规性的理由。 在本CCSG周期内，对PRMS进行了重大改进： ·PRMS职能的监督由新任命的SCI副主任石楠负责 Wakelee，MD，以加强PRMS与临床方案和数据管理的分离， 向临床研究副主任Mark Pegram，MD报告。 ·所有CRG都实施了研究优先级评分工具，以标准化第一阶段审查过程， 阐明拟议研究的影响，并促进试验的优先次序与SCI战略保持一致 计划和集水区癌症负担和人口统计学。 ·实施了一种利用应计制指数计算应计制进度的系统方法， 有效评估科学进步，从而改进行动规划。 ·每年审查所有开放累积5年或更长时间的干预性研究，以继续进行科学研究 本案无关 ·SRC实施了增强的数据和安全监测计划审查，以确保 管理计划与研究风险相称

PROJECT SUMMARY The overall mission of the Protocol Review and Monitoring System (PRMS) is to ensure that Stanford Cancer Institute (SCI) investigators execute clinical research that is scientifically meritorious, well designed, distributed across a broad range of cancer disciplines and feasible to conduct. The SCI Scientific Review Committee (SRC) and the disease or modality-oriented Clinical Research Groups (CRGs) together fulfill the PRMS responsibilities for cancer-related clinical research at the SCI and within Stanford. The CRGs conduct the first stage of the selection and prioritization of cancer-related clinical trials, and the SRC conducts the second stage. With the ultimate authority to approve studies, the SRC ensures all cancer-related clinical trials conducted at the SCI are of the highest scientific merit, align with the priorities of the SCI and are feasible to conduct. Over this CCSG cycle, the SRC reviewed an average of 140 new studies each year. The initial SRC study review determination across the grant period was 61% approved, 24% response required, 13% tabled and 2% rejected. An average of 116 studies were reviewed annually for scientific progress. The SRC is responsible for routine scientific progress reviews of studies and has the authority to suspend or close studies due to low accrual, stopping rule violations, changes in scientific relevance or other scientific- based or compliance-based rationales. Major improvements to the PRMS were implemented over this CCSG cycle: · Oversight of PRMS functions was moved under the newly appointed SCI Deputy Director, Heather Wakelee, MD, to enhance separation of PRMS from Clinical Protocol and Data Management which reports to the Associate Director for Clinical Research, Mark Pegram, MD. · A study priority scoring tool was implemented by all CRGs to standardize the first-stage review process, elucidate the impact of proposed studies and facilitate trial prioritization in alignment with the SCI Strategic Plan and catchment area cancer burden and demographics. · A systematic method to calculate accrual progress utilizing an accrual index was implemented for a more effective evaluation of scientific progress, leading to improved action planning. · Annual review of all interventional studies opened to accrual for 5 years or longer for continued scientific relevance. · Enhanced data and safety monitoring plan review was implemented by the SRC to ensure that the management plan was commensurate with the risks of the study