Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10239138
• 负责人: STACEY L BERG
• 金额: $ 5.32万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10239138
• 关键词: Amendment; Cancer Center; Cancer Center Support Grant; Cancer Control; Cancer Intervention; Cancer Therapy Evaluation Program; Cell Therapy; Clinic; Clinical; Clinical Cancer Center; Clinical Protocols; Clinical Research Protocols; Clinical Trials; Complement; Comprehensive Cancer Center; Concept Review; Conduct Clinical Trials; Consultations; Data; Descriptor; Development; Diagnostic Trial; Ensure; Funding; Funding Mechanisms; Goals; Health system; Hospitals; Industry; Institution; Institutional Review Boards; Intervention; Lead; Malignant Neoplasms; Medical center; Medicine; Methodist Church; Monitor; Observational Study; Pediatric Hospitals; Peer Review; Policies; Prevention; Process; Protocols documentation; Research; Research Personnel; Review Committee; Safety; Site; Supportive care; System; Texas; Time; United States National Institutes of Health; authority; cancer prevention; cancer research center director; college; epidemiology study; expedited review; gene therapy; group intervention; member; programs; working group

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) PROJECT SUMMARY The Dan L. Duncan Comprehensive Cancer Center (DLDCCC) at Baylor College of Medicine (BCM) has established the Protocol Review and Monitoring Committee (PRMC) to provide systematic internal oversight of the scientific and research aspects of all interventional cancer clinical protocols conducted in DLDCCC institutional facilities. By BCM and DLDCCC policy, the PRMC has authority to approve and close all DLDCCC clinical research protocols. Chaired by Stacey Berg, MD, the PRMC is organized into an Executive Committee and 3 Working Groups, with a total of 49 members. The PRMC assigns each protocol a scientific merit score of 1–9 according to standard NIH review descriptors. In addition, a DLDCCC priority score of High, Medium, or Low is assigned to aid protocol prioritization. Studies that have been approved by the NCI Cancer Therapy Evaluation Program or Cancer Prevention and Control Protocol Review Committee, or that are supported by an NIH funding mechanism that required full peer review as part of the funding process undergo an expedited administrative review. In addition, for multi-site institutional trials, the protocol may be eligible for expedited PRMC review if BCM is not the lead site and the approved PRMS of the lead site has performed full scientific review of the protocol. The PRMC also monitors progress and accrual of active studies. At the time of each open protocol's annual IRB review or more often if deemed necessary, the Executive Committee conducts a full review to ensure that adequate scientific progress is being made. In addition, the Executive Committee reviews the accrual to all open protocols in each Program on a quarterly basis. Protocols whose accrual continues to lag are subject to closure by the PRMC, as are protocols whose scientific goals may have been superseded by developments in the field. PRMC review complements, but does not duplicate, IRB or Data Safety Monitoring Committee review. From 2016 to 2018, the PRMC reviewed an average of 64 new submissions per year, including 10 DLDCCC investigator-initiated institutional, 27 National Group, 2 other externally peer reviewed, and 17 industry- sponsored protocols. In addition, an average of 226 progress reviews and 27 amendment reviews per year were also performed.

协议审核和监控系统（PRMS）项目摘要 贝勒医学院（BCM）的Dan L. Duncan综合癌症中心（DLDCCC） 建立了协议审查和监测委员会（PRMC），以提供系统的内部监督 在DLDCCC中进行的所有介入癌症临床方案的科学和研究方面 机构设施。通过BCM和DLDCCC政策，PRMC有权批准和关闭所有DLDCCC 临床研究方案。 PRMC由医学博士Stacey Berg主持，成立了执行委员会 和3个工作组，共有49名成员。 PRMC分配每个协议一个科学优点得分 根据标准NIH审查描述符1–9。此外，高，中或低的DLDCCC优先级评分 分配给辅助协议优先级。 NCI癌症治疗评估已批准的研究 计划或预防癌症控制协议审查委员会或NIH资金支持的计划审查委员会 需要全面同行审查作为资金过程的一部分的机制进行加速行政 审查。此外，对于多站点的机构试验，该协议可能有资格进行加急PRMC审查 BCM不是主要地点，铅网站的批准的PRM已对 协议。 PRMC还监视主动研究的进步和准确性。在每个公开协议的年度IRB时 执行委员会进行完整审查，以确保审查或更频繁地进行审查，以确保 正在取得足够的科学进步。此外，执行委员会还审查了所有公开的准确性 每季度中的每个程序中的协议。累积继续滞后的协议可能会关闭 通过PRMC，以及该方案可能已被该领域的发展所取代的协议也是如此。 PRMC审查完成，但不复制，IRB或数据安全监控委员会审查。 从2016年到2018年，PRMC平均每年审查64份新提交，其中包括10个DLDCCC 研究人员发动的机构，27个国家集团，其他2个外部同行评审，17个行业 - 赞助协议。此外，每年平均有226次进度审查和27个修正案评论 也执行。