340.633.01 DATA MANAGEMENT IN CLINICAL TRIALS

Acquaints students with important principles of the acquisition, management, and distribution of data in the clinical research environment. Topics focus 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. Does not focus on any particular type or size of study but 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. Discussions often stress the benefits and costs of alternatives rather than recommending particular courses of actions. Does not focus on computer programming, although it combines practical and hands-on exercises with advanced treatment of important concepts.

Upon successfully completing this course, students will be able to: explain basic and advanced concepts of data management; to make reasonable decisions about how to collect and manage data for studies of various sizes and budgets; to evaluate alternative courses of action and policies regarding data collection and management issues in a trial; to integrate data management activities into the conduct of a research project; and to communicate with or supervise other study staff involved with data management issues.