Clinical Data Management

Learn about the data elements used to conduct a clinical trial. Emphasis will be placed on accurate documentation, how the data is used for writing reports to regulatory agencies, and the importance of data organization. Enhance your knowledge of applicable FDA regulations (Part 11) and guidelines, and the documentation necessary to achieve FDA compliance. The course will be of interest to clinical data management professionals, clinical research coordinators, clinical research associates, project managers, and programmers who support the design and development of clinical databases.