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Covers applications of epidemiologic principles in the conduct of observational studies as taught in advanced epidemiologic methods. Focuses on developing skills to conduct and manage a research protocol, monitor data collection, manage data and disseminate results. Covers components of a clinical research team, responsibilities, expertise and tasks study members perform, and organizational, logistical and attitudinal issues that need to be addressed in producing an effective research group. Topics include infrastructure needed for single-site and multi-site studies, selection bias and analytical intent in the determination of populations and methods for recruitment, development of a manual of operations and forms for data collection and administration, data management tools, implementation and review of quality assurance, specimen repository tracking, and useful statistics for evaluating the progress of the study.