PRMS

方案审查和监测系统 UMCCC维持两个多学科委员会进行方案审查;方案审查 委员会（PRC）和癌症预防和控制PRC（CPC PRC）。的目标 委员会包括： (1)就拟在本中心进行的所有临床试验研究的科学价值提供同行评审， 密歇根大学综合癌症中心（UMCCC） (2)确定癌症中心资源使用的优先顺序（临床试验办公室，癌症中心 核心、空间和患者） (3)提高癌症中心临床研究的整体质量 (4)提供操作监督，以确保支持的方案取得充分的科学进展 PRC审查了所有癌症相关治疗（包括I期）临床研究方案， 癌症中心资源在提交给机构IRB之前，必须进行该审查。此外，本发明的目的是， 涉及知情同意并包括癌症中心患者的相关或成像研究， 但须经委员会审查。癌症控制研究、预防研究、健康研究和生活质量 没有治疗成分的试验和其他类似的研究方案由CPC-PRC审查。 先前已由公认的同行评审机构进行同行评审的协议可免于 由全体委员会进行科学审查，但由PRC主席或其 指定人员。所有新的临床研究方案和非管理性修订， 经批准的试验由PRC审查。不需要PRC审查且可能合格的研究 供中国共产党审查的文件包括： (1)无治疗成分的研究（即调查、焦点组试验、HRQOL试验）。 (2)非癌症患者的癌症预防研究 (3)癌症控制研究 UMCCC方案审查和监测系统符合所有NIH、FDA和密歇根大学的要求。 临床研究指导原则。

PROTOCOL REVIEW AND MONITORING SYSTEM The UMCCC maintains two multidisciplinary committees for protocol review; the Protocol Review Committee (PRC) and the Cancer Prevention and Control PRC (CPC PRC). The objectives of the committees are: (1) To provide peer review of the scientific merit of all clinical trial research to be conducted at the University of Michigan Comprehensive Cancer Center (UMCCC) (2) To define priorities for the use of the Cancer Center resources (Clinical Trials Office, Cancer Center cores, space and patients) (3) To improve the overall quality of clinical research throughout the Cancer Center (4) To provide operational oversight to ensure sufficient scientific progress of supported protocols The PRC reviews all cancer-related therapeutic (including Phase I) clinical research protocols which use cancer center resources. This review is mandatory before submission to the institutional IRB. Additionally, correlative or imaging studies that involve informed consent and include Cancer Center patients are subject to committee review. Cancer control studies, prevention studies, health research and quality of life trials without a therapy component and other similar research protocols are reviewed by the CPC-PRC. Protocols that have been previously peer reviewed by recognized peer-review bodies are exempt from the scientific review by the full committee, but are administratively reviewed by the chair of the PRC or his/her designee. All new clinical research protocols and non-administrative amendments to active, previously approved trials are reviewed by the PRC. Studies not requiring review by the PRC and potentially eligible for review by the CPC-PRC include the following: (1) Studies without a treatment component (i.e. surveys, focus group trials, HRQOL trials). (2) Cancer prevention studies in non-cancer patients (3) Cancer control studies The UMCCC Protocol Review and Monitoring system adheres to all NIH, FDA and University of Michigan guidelines for the conduct of clinical research.