Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10674570
• 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/10674570
• 关键词: Amendment; Authorization documentation; 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; Data; Descriptor; Development; Diagnostic Trial; Eligibility Determination; 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）项目总结 丹·L.贝勒医学院的邓肯综合癌症中心（DLDCCC） 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进行的所有介入性癌症临床方案的科学和研究方面 机构设施。根据合同和DLDCCC政策，PRMC有权批准和关闭所有DLDCCC 临床研究方案。主席斯泰西贝格，医学博士，PRMC是组织成一个执行委员会 和3个工作组，共有49名成员。PRMC为每个方案分配一个科学价值分数， 1-9根据标准NIH综述描述符。此外，DLDCCC优先级得分为高、中或低 被分配用于辅助协议优先化。NCI癌症治疗评估批准的研究 计划或癌症预防和控制协议审查委员会，或由NIH资助 作为供资进程一部分需要全面同行审议的机制， 审查.此外，对于多中心机构试验，如果符合以下条件，方案可能有资格进行快速PRMC审查： FDA不是牵头研究中心，牵头研究中心的批准PRMS已对 议定书 PRMC还监测积极研究的进展和累积。在每个开放方案的年度IRB时 执行委员会进行全面审查，以确保 取得了充分的科学进步。此外，执行委员会审查所有未结账户的应计费用， 每季度在每个方案中提供一份协议。应计费用继续滞后的协议将被关闭 由PRMC，因为是议定书的科学目标可能已被取代的发展领域。 PRMC审查是对IRB或数据安全监查委员会审查的补充，而不是重复。 从2016年到2018年，PRMC平均每年审查64份新提交的申请，其中包括10份DLDCCC 27个国家小组，2个其他外部同行审查，17个行业- 赞助协议。此外，平均每年进行226次进展审查和27次修正审查， 也执行。