Protocol Review & Monitoring

罗斯威尔公园癌症研究所（RPCI）的协议审查和监测是在直接指导下进行的

Protocol Review and Monitoring at Roswell Park Cancer Institute (RPCI) is under the direct supervision of Dr Alex Adjei, Associate Director for Clinical Research. Components include the Scientific Review Committee (SRC), the Response Review Committee (RRC), the Clinical Research Management System (CRMS) and the new Clinical Research Feasibility and Prioritization Committee (CRFPC). The SRC provides oversight and assures the maintenance of high quality institutional clinical research. All research studies conducted at RPCI are reviewed by the SRC prior to submission to the IRB. The scope of the SRC responsibilities includes review and approval of new and ongoing clinical research studies, review and approval of study amendments and review and approval of the outcome of the analysis of non-accruing and slow accruing studies. The SRC reviews new studies to ensure that scientific content and study design are appropriate and that statistical oversight and collaboration is in place. The review of non-accruing and slow accruing studies occurs twice annually. The SRC provides a forum where the utilization of RPCI resources and the prioritization of clinical research studies are discussed. The Response Review Committee is charged with monitoring radiological response assessment and reporting the outcome of the review to the Scientific Review Committee and the Data and Safety Monitoring Board. Ellis Levine, MD, chairs the Response Review Committee and Alan Li twin, MD, provides the radiological review conducted by the Response Review Committee. Under the leadership and supervision of Dr Alex Adjei, Joyce Yasko, PhD oversees the function of the SRC including the development of prompt SRC communication of the outcome of the SRC review with the Principal Investigators and the review of slow or non accruing research studies. Julie Haney BS, CRS Director, Study Submission and Regulatory Affairs provides the administrative support for the role, responsibilities and outcomes of the SRC. Jennifer Cartonia provides critical secretarial support to the SRC.