PRMS

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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.