Protocol Review and Monitoring at Roswell Park Cancer Institute (RPCI) is under the directsupervision of Dr Alex Adjei, Associate Director for Clinical Research. Components include the ScientificReview Committee (SRC), the Response Review Committee (RRC), the Clinical Research ManagementSystem (CRMS) and the new Clinical Research Feasibility and Prioritization Committee (CRFPC). The SRCprovides oversight and assures the maintenance of high quality institutional clinical research. All researchstudies conducted at RPCI are reviewed by the SRC prior to submission to the IRB. The scope of the SRCresponsibilities includes review and approval of new and ongoing clinical research studies, review andapproval of study amendments and review and approval of the outcome of the analysis of non-accruing andslow accruing studies. The SRC reviews new studies to ensure that scientific content and study design areappropriate and that statistical oversight and collaboration is in place. The review of non-accruing and slowaccruing studies occurs twice annually. The SRC provides a forum where the utilization of RPCI resourcesand the prioritization of clinical research studies are discussed.The Response Review Committee is charged with monitoring radiological response assessment andreporting the outcome of the review to the Scientific Review Committee and the Data and Safety MonitoringBoard. Ellis Levine, MD, chairs the Response Review Committee and Alan Li twin, MD, provides theradiological review conducted by the Response Review Committee.Under the leadership and supervision of Dr Alex Adjei, Joyce Yasko, PhD oversees the function ofthe SRC including the development of prompt SRC communication of the outcome of the SRC review withthe Principal Investigators and the review of slow or non accruing research studies. Julie Haney BS, CRSDirector, 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 theSRC.
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