The Administrative Core includes biostatistics, clinical trials management, nursing, and pharmacy. This coreplays an integral part in all projects, providing a closely interactive biostatistics group that is integrated intoeach 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 theclinical trials, and preclinical experiments. The Administrative Core supports data management through theOffice of Clinical Research at MSKCC. This office is responsible for patient registration, data managementsupport, quality assurance/control, regulatory affairs and interfacing with the FDA, protocol oversight, andassisting protocol review. The data managers on this program attend meetings weekly and participate inclinic sessions where patients are treated. The Immunology Research Nurses are experienced nurses whodeliver therapies including mAb and vaccines, perform patient monitoring, and record data of toxicity. Finallythe research pharmacist handles and stores vaccines, and prepares them for treatment, with maintenance ofappropriate records.
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