PROTOCOL REVIEW AND MONITORING SYSTEM

NYUCI的方案审查和监测系统（PRMS）负责评估在NYU Langone医学中心校园及其战略联盟中进行的所有癌症相关人群，转化和临床研究的科学价值。一旦完成临床方案文件，PRMS将提供一个多层次审查的论坛，以确认科学价值和方案适合性。在纽约大学医学院机构审查委员会（IRB）批准该方案后，PRMS监测科学进展和性能。PRMS的核心是方案审查和监测委员会（PRMC）。PRMC成员来自NYUCI成员，基于临床试验开发和实施方面的专业知识以及关键临床职位的领导能力。该委员会的医生成员代表在NYUCI内提供护理和参与临床研究的不同亚专科。此外，PRMC还包括实验室科学家、生物统计学家、NYUCI的行政人员、肿瘤学护理人员和研究药物。需要PRMC批准才能提交和批准IRB。PRMC审查包括基本假设、设计和试验将产生有临床意义结果的可能性。PRMC每年监测招募情况，并要求研究者提供正式计划，以在招募情况<预期目标的50%时增加招募。该委员会有权结束累积不足的审判。研究者发起的研究是NYUCI的最高优先级，特别是那些涉及基于NYUCI基础和/或转化科学家实验室结果的新型药物的研究。自上次审查以来，审查的议定书数量有所增加。2011年，PRMC审查了126份协议，而2007年为94份。

The Protocol Review and Monitoring System (PRMS) for the NYUCI is responsible for evaluating the scientific merit of all cancer-related population-based, translational and clinical research studies that take place on the NYU Langone Medical Center campus and those of its strategic alliances. Once the clinical protocol documentation has been completed, the PRMS provides a forum for multi-level review, confirming the scientific merit and programmatic fit. After the NYU School of Medicine Institutional Review Board (IRB) approves the protocol, the PRMS monitors for scientific progress and performance. A central core of the PRMS is the Protocol Review and Monitoring Committee (PRMC). PRMC membership is drawn from the membership of the NYUCI based on expertise in the development and conduct of clinical trials, as well as leadership in key clinical positions. Physician members of the committee represent the different subspecialties providing care and participating in clinical research within the NYUCI. In addition, the PRMC includes bench scientists, biostatisticians, members of the administrative staff of the NYUCI, oncology nursing and the investigational pharmacy. PRMC approval is required for IRB submission and approval. PRMC review includes the underlying hypothesis, design, and the likelihood that the trial will lead to clinically meaningful results. The PRMC monitors accrual yearly and requires that investigators provide a formal plan to increase enrollment if accrual is < 50% of projected target. The PRMC has the authority to close under-accruing trials. Investigator initiated studies are the highest priority for the NYUCI especially those involving novel agents based on laboratory results from NYUCI basic and/or translational scientists. The number of reviewed protocols has increases since the last review. In 2011, PRMC reviewed 126 protocols as compared to 94 in 2007.