PROTOCOL REVIEW AND MONITORING SYSTEM (Core 019)

摘要-方案审查和监测系统（PRMS） Lineberger综合癌症中心的PRMS促进了科学研究的内部监督。 北卡罗来纳州大学所有癌症临床试验的各个方面，重点是科学价值，优先事项， 临床方案研究进展。该系统是一个多步骤的过程，初步审查由 礼宾办公室疾病小组和礼宾办公室执行委员会，随后是 方案审查委员会（PRC）的正式审查。 PRC由医学博士Peter Voorhees担任主席，每两个月召开一次会议，审查每一个癌症相关的临床 在提交给人类研究伦理办公室的机构审查委员会（IRB）之前，的 PRC的主要职能是确保拟议研究的科学质量。如临床方案所述 和数据管理（CPDM），POD和POEC审查方案的可行性，质量和优先级 它们被提交给PRC。PRC监控研究应计费用，并有权在以下情况下关闭- 进行审判2014年，PRC审查了295项方案，其中112项新研究和183项正在进行的试验， 更新和监测。

Abstract – Protocol Review and Monitoring System (PRMS) The UNC Lineberger Comprehensive Cancer Center's PRMS facilitates internal oversight of the scientific aspects of all cancer clinical trials at the University of North Carolina focusing on the scientific merit, priorities, and progress of clinical protocol research. The system is a multi-step process with preliminary review by Protocol Office Disease teams (PODs) and the Protocol Office Executive Committee (POEC), followed by a formal review by the Protocol Review Committee (PRC). The PRC is chaired by Peter Voorhees, MD, and meets bi-monthly to review every cancer-related clinical protocol before it is submitted to The Office of Human Research Ethics' Institutional Review Board (IRB). The PRC's primary function is to ensure the scientific quality of proposed studies. As described in Clinical Protocol and Data Management (CPDM), PODs and POEC review protocols for feasibility, quality, and priority before they are submitted to the PRC. The PRC monitors study accrual and has the authority to close under- performing trials. During 2014, the PRC reviewed 295 protocols -- 112 new studies and 183 active trials for renewal and monitoring.