Protocol Review and Monitoring System

协议审查和监测系统(PRMS) 摘要 JCCC方案审查和监测系统(PRMS)的目标是确保所有加州大学洛杉矶分校的临床 癌症研究应用合理的科学方法为JCCC、癌症和 科学界、提供者，最重要的是为JCCC集水区及其周围的患者提供服务， 洛杉矶县(LAC)。在JCCC主任Michael Teitell，MD，PhD(CMINT)的权限下， PRMS监督加州大学洛杉矶分校进行的所有与肿瘤学相关的临床研究。这一疏忽包括 干预性的、非干预性的，以及一些更基础的癌症研究。PRMS执行严格的 对涉及人类受试者或标本的研究进行科学审查，包括但不限于治疗， 预防、诊断、筛查和其他干预措施。PRMS的工作是确保临床研究 合理确定优先顺序，并有效利用JCCC现有资源和指导。 在之前的项目期内，JCCC领导层修订了项目管理系统的结构和职能。PRMS的核心是 在联合专家委员会的授权下，建立内部科学同行审查委员会(ISPRC) 1993年。ISPRC是JCCC议定书审查和监测委员会(PRMC)。作为该计划的一部分 重组项目管理系统，进一步符合《国家预防犯罪准则》并满足联合协调中心的需要 调查人员，新任命的PRMS主任，John Glaspy，医学博士，公共卫生硕士(STT)，建立了一个两阶段 审查所有JCCC机构干预试验的流程。这一进程涉及一个新的委员会，即 机构礼宾委员会(IPC)，负责对JCCC机构试验概念进行初步审查或 提交ISPRC之前的协议。只有获得IPC批准的研究才会继续进行审查 ISPRC。这一过程始于2019年初，作为考察研究的完整性、效率和质量的试点 向ISPRC提交的材料。一旦提交给ISPRC，成员审查研究方案并与 研究所需的科学方法、统计方法、患者群体和JCCC资源 执行力，包括人员配备、专业知识、临床研究设施和任何必要的基础设施。平等的 重要的是ISPRC对正在进行的干预试验进行审查，以确保研究进展、适当的执行、 和及时的患者收益，以满足研究终点。作为研究进展审查的一部分，继续进行科学研究 临床试验的贡献也被考虑在内。ISPRC可要求对试验或研究人员进行特别审查 根据报告或根据议定书和条例确定的与审判执行有关的问题， 可能使数据、结果和最终的科学贡献化为乌有。PRMS提供免费和 机构审查委员会(IRB)的必要但不重叠的职能。

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) ABSTRACT The objective of the JCCC Protocol Review and Monitoring System (PRMS) is to ensure that all UCLA clinical cancer studies apply sound scientific approaches to produce meaningful results for the JCCC, cancer and scientific communities, providers, and most importantly for patients in and around the JCCC catchment area, Los Angeles County (LAC). Under the purview of the JCCC Director, Michael Teitell, MD, PhD (CMINT), the PRMS has oversight of all oncology-related clinical research conducted at UCLA. This oversight includes interventional, non-interventional, and some more basic science cancer studies. The PRMS performs rigorous scientific review of studies involving human subjects or specimens, including, but not limited to, treatment, prevention, diagnosis, screening, and other interventions. The PRMS works to assure that clinical studies are appropriately prioritized and utilize available JCCC resources and guidance efficiently. Over the prior project period, JCCC leadership revised the PRMS structure and functions. The core of the PRMS remains the Internal Scientific Peer Review Committee (ISPRC), under the authority of the JCCC, established in 1993. The ISPRC serves as the JCCC protocol review and monitoring committee (PRMC). As part of the reorganization of the PRMS, in further alignment with NCI-guidelines and meeting the needs of JCCC investigators, the newly appointed Director of PRMS, John Glaspy, MD, MPH (STT), established a two-stage review process for all JCCC institutional interventional trials. This process involves a new committee, the Institutional Protocol Committee (IPC), which conducts an initial review of JCCC institutional trial concepts or protocols prior to ISPRC submission. Only studies that receive IPC approval move forward for review by the ISPRC. This process began in early 2019 as a pilot looking at the completeness, efficiency, and quality of study submissions to the ISPRC. Once submitted to the ISPRC, members review the research protocol and associated scientific approaches, statistical approaches, patient populations, and JCCC resources required for study execution including staffing, expertise, clinical research facilities, and any necessary infrastructure. Of equal importance is ISPRC review of on-going interventional trials to ensure study progress, appropriate execution, and timely patient accrual to meet study endpoints. As part of study progress review, the continued scientific contribution of the clinical trial is also considered. The ISPRC may request ad-hoc reviews of trials or researchers based upon reports or identified issues related to trial execution according to the protocol and regulations, which may possibly nullify data, results, and ultimately scientific contribution. The PRMS provides complimentary and necessary, but non-overlapping, functions to the institutional review board (IRB).