CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

北卡罗来纳大学莱恩伯格大学礼宾审查和监测系统的主要组成部分是礼宾审查委员会(PRC)，由Tom Shea博士担任主席。由28人组成的中华人民共和国每两周举行一次会议，审查每一项与癌症相关的临床试验方案，然后将其提交给OHRP批准的北卡罗来纳大学医学院保护人类受试者权利委员会(IRB)。中华人民共和国的主要职能是确保拟议研究的科学质量和患者安全，并确定研究的优先顺序。中华人民共和国还监测研究的应计费用，并建议关闭表现不佳的试验。中华人民共和国与数据和安全监测委员会(DSMC)和肿瘤学方案审计委员会(OPAC)合作，审查患者的安全性和试验的适当进行。总体来说，中国的使用量相对稳定 或者在过去五年里缓慢增长。虽然审查的新方案的数量相对不变，但研究的复杂性有所增加。随着对临床研究、新疗法和行为干预的持续战略重视，该中心预计在北卡罗来纳大学LCCC启动的新临床试验的数量将会增加，目前试验的质量、复杂性和强度也将继续提高。此外，该中心还正式成立了由克莱尔·迪斯博士领导的第一阶段开发治疗小组。这些趋势将增加进入中国的新审判的数量，并继续增加续签申请的数量。

The principal component of the UNC Lineberger's Protocol Review and Monitoring Systems is the Protocol Review Committee (PRC), chaired by Dr. Tom Shea. The 28-person PRC meets bi-weekly and reviews every cancer-related clinical trial protocol before it is submitted to the OHRP-approved UNC School of Medicine Committee for the Protection of the Rights of Human Subjects (IRB). The PRC's primary function is to ensure the scientific quality and patient safety of proposed studies and determine study priority. The PRC also monitors study accrual and recommends closure of under-performing trials. The PRC works with the Data and Safety Monitoring Committee (DSMC) and the Oncology Protocol Audit Committee (OPAC) on review of patient safety and the proper conduct of a trial. Overall PRC use has been relatively steady or slowly growing over the past five years. While the number of new protocols reviewed has been relatively constant, the complexity of the studies has increased. With a continuing strategic emphasis on clinical research, novel therapeutics, and behavioral interventions, the Center expects increases in the number of new clinical trials initiated at UNC LCCC, as well as a continued increase in the quality, complexity, and intensity of the current trials. In addition, the Center has formalized a Phase I Developmental Therapeutics group under the leadership of Dr. Claire Dees. These trends will increase the number of new trials coming to the PRC and continue to increase the number of renewal applications.