9.10.1 ABSTRACT: CLINICAL PROTOCOL AND DATA MANAGEMENT {Clinical Trials Office) Director, Scott Baker. M.D., M.S. The mission of the University of Minnesota Cancer Center (UMCC) Clinical Protocol and Data Management Shared Resource (hereafter referred to;as the Clinical Trials Office [CTO]) is to provide a resource to UMCC investigators allowing them to perform high quality clinical research that insures validity and integrity of data and fulfiHs all NCI, federal, and local regulatory requirements. The CTO's centralized services enable the investigator to initiate and participate in a wider spectrum of clinical research activities, with the primary focus on supporting the development of investigator-initiated novel therapeutic strategies that arise out of the various UMCC research programs. In addition, the CTO is a center of excellence for clinical trial planning, execution and training. The CTO provides a centralized location for the development, administration and conduct all cancer protocols including investigator initiated IND/IDE trials and all related correspondences with regulatory agencies including the University of Minnesota Institutional Review Board (IRB), National Institutes of Health (NIH) and U.S. Food and Drug Administration (FDA). The Clinical Trial Office provides four major distinct functions: 1) Clinical Trial Operations and Management, 2) Regulatory Affairs 3) Quality Control/Assurance 4) Systems Management and Resources. In conjunction with the principal investigator the CTO staff channel the development of a new clinical trial from protocol design, protocol review and approval, research staff education, study implementation, data collection and entry, through trial completion. The CTO supports investigator-initiated therapeutic and non-therapeutic studies which may be sponsored by the NCI, NHLBI or other NIH branches, in addition to cooperative group and industry studies. From September 1, 2006 to August 31,2007, more than 300 clinical trials were registered with the CTO and open to patient accrual. Of these, 29% were investigator initiated institutional trials.
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