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Data Management in Clinical Trials

Acquaints students with important principles of the acquisition, management, and distribution of data in the clinical research environment. Focuses on real-world needs of investigators and emphasizes those issues that researchers need to understand to work effectively with other members of study teams, including coordinators, data entry staff, programmers, and data managers. Covers topics that apply to many studies, and discusses approaches ranging from small single-investigator trials using only a spreadsheet through international networks using sophisticated web-based data management systems, although does not focus on any particular type or size of study. Discusses the benefits and costs of alternatives rather than recommending particular courses of actions. Combines practical and hands-on exercises with advanced treatment of important concepts, although it does not focus on computer programming.