CORE--CLINICAL RESEARCH SERVICES CLINICAL TRIALS OFFICE

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The Clinical Research Services (CRS) was established in December 1986 as a shared resource to facilitate development, implementation, and completion of all UPCI clinical research studies. CRS provides study development and implementation assistance, IRB processing, patient recruitment, study coordination, and specimen and data collection for all investigators conducting cancer-related studies at all UPMC Cancer Centers. The University of Pittsburgh Cancer Institute (UPCI) recently reorganized its clinical research organization to be in a better position to rapidly implement clinical trials and to comply with the more stringent regulatory requirements. To achieve these goals, additional infrastructure has been developed, to ensure timely review by the regulatory bodies, review by legal counsel for both UPMC and the University of Pittsburgh, budgetary negotiations with sponsors, and financial review of all aspects of the clinical trial. CRS facilitates IRB review of all clinical research studies approvcd by the PRC, and for which needed resources are allocated. The CRS database maintains up to date on the status of each study, including timely submission of all required documents and amendments to the IRB, study renewal forms, progress reports, Data Safety Monitoring information, Serious Adverse Events, monthly reports, IRB and other correspondences.