PROTOCOL REVIEW MONITORING SYSTEM

9.2临床试验方案审查和监测委员会 作为我们NCI指定的一部分，Chao Family Comprehensive Cancer Center（CFCCC）的临床试验 方案审查和监测委员会（CTPRMC）是主要的方案审查和监测机构。 系统（PRMS）。CTPRMC审查试验的科学价值，研究设计的充分性， 生物统计学问题。审咨委还持续监测审判应计制。CTPRMC 成员资格反映了试验科学审查所需的专业知识，由CFCCC成员组成 和其他教师和工作人员从不同领域的必要的完整审查， 制药公司赞助的试验 目前，所有涉及癌症患者的研究，包括制药商发起的方案和行业赞助的研究， 试验，必须在提交给CTPRMC之前接受CTPRMC的审查，并由 机构审查委员会（IRB）。不涉及干预的研究，如观察性、登记研究， 标本储存库和回顾性图表审查研究可能符合CTPRMC豁免的条件， 由临床研究办公室主任确定。此外，合作组试验是豁免的 如果他们已经接受了两个合作小组的事先同行审查， 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问题。 CTPRMC义务。这些试验的优先顺序由疾病特异性组在 CFCCC，由CFCCC临床研究副主任监督。CTPRMC会议 每月两次（交替举行全体委员会和小组委员会会议），审查议定书的基本内容， 包括明确的理由、适当和有效的研究设计、生物统计学输入、可实现的应计费用，以及 在合理的时间范围内完成的可行性。

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.