CLINICAL TRIALS OFFICE The Clinical Trials Office (CTO) provides infrastructure support for the conduct of clinical trials at the University of Michigan Comprehensive Cancer Center. CTO services are grouped into three major categories;regulatory services, data management services, and information technologies services. Major areas of responsibility include support for regulatory submissions to the IRB, two Protocol Review Committees (therapeutic and prevention), GCRC and other institutional review committees, FDA, and NCI. The CTO provides data management services for PRC-approved clinical trials as well as serving as a centralized data repository for research data generated on clinical trials. These services include study implementation, data collection and entry, and submission to investigators and outside sponsors. The information technology services include Case Report Form (CRF) development and database implementation and maintenance. The primary mission of the CTO is to assist the Cancer Center investigators in the development, conduct, and reporting of innovative clinical research in an efficient, regulatory compliant, and scientifically sound manner.
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