PROTOCOL REVIEW MONITORING SYSTEM

方案审查监控系统

• 批准号: 7944577
• 负责人: FRANK L. MEYSKENS
• 金额: $ 4.63万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-06 至 2012-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7944577
• 关键词: Appointment; Cancer Center Support Grant; Cancer Patient; Clinical Research; Clinical Trials Cooperative Group; Clinical trial protocol document; Committee Membership; Comprehensive Cancer Center; Disease; Electronics; Elements; Faculty; Family; Future; Goals; Intervention; Monitor; Peer Review; Pharmacists; Pharmacologic Substance; Program Evaluation; Protocols documentation; Qualifying; Registries; Research Design; Research Ethics Committees; Research Personnel; Review Committee; Schedule; Secure; Specialist; Specimen; System; Time; University of California Irvine Cancer Center; Work; base; cancer site; meetings; member; professor; repository

9.2 Clinical Trials Protocol Review & Monitoring Committee As part of our NCI designation, the Chao Family Comprehensive Cancer Center's (CFCCC) Clinical Trials Protocol Review & Monitoring Committee (CTPRMC) serves as the primary Protocol Review and Monitoring System (PRMS). The CTPRMC reviews trials for scientific merit, adequacy of study design, and biostatistical concerns. The Committee also monitors trial accrual on an ongoing basis. The CTPRMC membership reflects the expertise required for the scientific review of trials and consists of CFCCC members and other faculty and staff from diverse fields necessary for complete review of investigator-initiated and pharmaceutical company sponsored trials. Currently, all studies involving cancer patients, including investigator-initiated protocols and industrysponsored trials, must undergo review by the CTPRMC prior to submission to, and review by, the Institutional Review Board (IRB). Studies that do not involve an intervention, such as observational, registry, specimen repository, and retrospective chart reviews studies, may qualify for CTPRMC exemption, as determined by the Director of the Clinical Research Office. In addition, cooperative group trials are exempt from initial review by the CTPRMC if they have received prior peer review by both the cooperative groups and the Clinical Trial Evaluation Program (CTEP). However, monitoring accrual for these trials remains a CTPRMC obligation. Prioritization of these trials is determined by the disease-specific groups at the CFCCC, supervised by the Associate Director for Clinical Research of the CFCCC. The CTPRMC meets twice monthly (alternating full Committee and sub-Committee), to review the essential protocol elements, including clear rationale, appropriate and efficient study design, biostatistical input, attainable accrual, and feasibility for completion within a reasonable time frame.

9.2临床试验方案审查和监测委员会 作为我们NCI认证的一部分，赵氏家族综合癌症中心(CFCCC)的临床试验 礼宾审查和监测委员会(CTPRMC)是主要的礼宾审查和监测 系统(PRMS)。CTPRMC审查试验的科学价值、研究设计的充分性，以及 生物统计学方面的问题。委员会还持续监测审判应计费用。CTPRMC 成员反映了对试验进行科学审查所需的专业知识，由CFCCC成员组成 以及来自不同领域的其他教职员工，以完成对调查人员发起和 制药公司赞助的试验。 目前，所有涉及癌症患者的研究，包括研究人员发起的方案和行业赞助的 试验，必须在提交给委员会和由委员会审查之前接受CTPRMC审查 院校评审委员会(IRB)。不涉及干预的研究，如观察性研究、注册研究、 标本库和回顾图表审查研究可能有资格获得CTPRMC豁免，因为 由临床研究室主任决定。此外，合作小组试验不受限制 如果两个合作小组事先都接受了同行审查，则不再接受禁毒委的初次审查 和临床试验评估计划(CTEP)。然而，监测这些试验的应计费用仍然是一个 CTPRMC义务。这些试验的优先顺序由疾病特定小组在 CFCCC，由CFCCC临床研究副主任监督。CTPRMC召开会议 每月两次(全体委员会和小组委员会轮流)，以审查基本的议定书要素， 包括明确的理论基础，适当和有效的研究设计，生物统计学投入，可实现的应计利润，以及 在合理的时间框架内完成的可行性。