Protocol Review & Monitoring

罗斯威尔公园癌症研究所(RPCI)的方案审查和监测正在直接进行 临床研究副主任Alex Adjei博士的监督。组件包括科学的 评审委员会(SRC)、反应评审委员会(RRC)、临床研究管理 系统(CRMS)和新的临床研究可行性和优先排序委员会(CRFPC)。SRC 提供监督并确保维持高质量的机构临床研究。所有研究 在RPCI进行的研究在提交给IRB之前由SRC进行审查。SRC的范围 职责包括审查和批准新的和正在进行的临床研究、审查和 批准研究修订并审查和批准非应计项目和 学习进展缓慢。SRC审查新的研究，以确保科学内容和研究设计 适当，并确保统计监督和协作到位。非应计项目和迟延项目的回顾 累积研究每年进行两次。SRC提供了一个论坛，在这个论坛上，RPCI资源的利用 并对临床研究的优先顺序进行了讨论。 反应审查委员会负责监测辐射反应评估和 向科学审查委员会以及数据和安全监测报告审查结果 冲浪板。Ellis Levine医学博士担任响应审查委员会主席，Alan Li TWin医学博士提供 由反应审查委员会进行的放射审查。 在Alex Adjei博士的领导和监督下，Joyce Yasko博士负责监督 SRC包括制定SRC与SRC审查结果的即时沟通 首席调查员和对缓慢或非累积研究的审查。朱莉·哈尼·BS，CRS 主任、研究报告提交和法规事务为这一角色提供行政支持， SRC的责任和结果。Jennifer Cartonia为 SRC。

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.