The Administrative Core includes biostatistics, clinical trials management, nursing, and pharmacy. This core plays an integral part in all projects, providing a closely interactive biostatistics group that is integrated into each Project, nursing, data management and pharmacy support for all clinical trials throughout Projects 1-3. The role of the biostatistics group for this project is to contribute to the design, conduct and analysis of the clinical trials, and preclinical experiments. The Administrative Core supports data management through the Office of Clinical Research at MSKCC. This office is responsible for patient registration, data management support, quality assurance/control, regulatory affairs and interfacing with the FDA, protocol oversight, and assisting protocol review. The data managers on this program attend meetings weekly and participate in clinic sessions where patients are treated. The Immunology Research Nurses are experienced nurses who deliver therapies including mAb and vaccines, perform patient monitoring, and record data of toxicity. Finally the research pharmacist handles and stores vaccines, and prepares them for treatment, with maintenance of appropriate records.
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