Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10439834
• 负责人: STACEY L BERG
• 金额: $ 4.66万
• 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/10439834
• 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.

方案审查和监测系统 (PRMS) 项目摘要 贝勒医学院 (BCM) 的 Dan L. Duncan 综合癌症中心 (DLDCCC) 已 建立了方案审查和监测委员会（PRMC），以提供系统的内部监督 在 DLDCCC 进行的所有介入癌症临床方案的科学和研究方面 根据 BCM 和 DLDCCC 政策，PRMC 有权批准和关闭所有 DLDCCC。 PRMC 由医学博士 Stacey Berg 担任主席，下设一个执行委员会。 PRMC 设有 3 个工作组，共有 49 名成员，为每个方案分配科学评分。 根据标准 NIH 审查描述符，1-9 此外，DLDCCC 优先级评分为高、中或低。 被指定协助已获得 NCI 癌症治疗评估批准的方案优先级研究。 计划或癌症预防和控制方案审查委员会，或由 NIH 资助支持的计划 需要全面同行审查作为供资流程一部分的机制需要经过快速行政审查 此外，对于多中心机构试验，如果满足以下条件，该方案可能有资格获得快速 PRMC 审查。 BCM 不是牵头场所，牵头场所经批准的 PRMS 已对 BCM 进行了全面的科学审查 协议。 PRMC 还在每个开放协议的年度 IRB 期间监控活跃研究的进展和累积情况。 审查，或者执行委员会认为有必要时更频繁地进行全面审查，以确保 此外，执行委员会正在审查所有开放的应计费用。 每个计划中每季度的协议 其应计持续滞后的协议可能会被关闭。 由 PRMC 作为协议，其科学目标可能已被该领域的发展所取代。 PRMC 审查补充但不重复 IRB 或数据安全监控委员会的审查。 2016年至2018年，PRMC平均每年审查64份新提交的申请，其中包括10份DLDCCC 研究者发起的机构、27 个国家组、2 个其他外部同行评审以及 17 个行业- 此外，每年平均进行 226 次进度审查和 27 次修订审查。 也表演了。