The field of clinical research is expanding, driven by changing disease patterns and emerging therapeutic approaches from the laboratory, clinical and population sciences. There are growing concerns about the quality and safety of research in humans, and there are increasing regulations by the U.S. Food and Drug Administration. The result is an increasing demand for individuals trained in clinical research design and implementation.

The need and demand reaches beyond Minnesota. The epidemiologic transition, which posits increasing numbers of chronic diseases throughout the developing world, expands the need for testing innovative therapies.

The Certificate program prepares students to:

• Understand different study design approaches
• Review and Critique the literature in the field
• Understand research study implementation, data collection and quality control
• Understand good clinical practice in research studies
• Understand the factors associated with ethical conduct of research
• Understand statistical approaches to analyze clinical research data
• Understand the role of the FDA, industry and the NIH in clinical research

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