Clinical trials are an essential component of Research Projects 1, 2, 4 and 5. The Clinical Trial Core exists to support all of the clinical trials research conducted within the context of this SPORE grant. This Core provides the necessary infrastructure to develop, organize and execute any clinical trial. MSKCC has a comprehensive network at both the institutional and departmental levels which provides the required oversight and guidance for the conduct of human subject research. The Office of Clinical Research at MSKCC is the primary body which governs clinical trials. This office supervises clinical trials, manages the institutional clinical research database, performs audits to assure high quality data and accuracy of reporting, and provides uniform training and quality control for all research study assistants. Protocol development is initiated by the central nervous system multidisciplinary disease management team and then must be approved first at the MSKCC Research Council for scientific merit and, subsequently, at the IRB to assure patient safety and compliance with all local and Federal regulations. The Clinical Trials Core will provide these services in a coordinated and organized fashion for all of the SPORE investigators.
