This is the REd Online (ASYNCHRONOUS) Class.

Class Description: Information and materials to prepare investigators and research personnel to initiate, manage and oversee a drug or device trial at the University will be presented. The Food and Drug Administration (FDA) Investigational New Drug (IND) and Investigational Device Exemption (IDE) requirements will be described. Topics such as additional investigator responsibilities, the IRB submission and approval process including pre-approval audit, and methods of continued study oversight will be discussed.

Class Objectives: At the conclusion of this class, you should be able to:

• Identify when an IND is necessary from the FDA
• Describe FDA requirements
• Describe IRB requirements
• Summarize the extra responsibilities for these studies

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Instructor:

Sarah Mumford, MBA, CIP
Associate Director, Institutional Review Board
sarah.mumford@hsc.utah.edu
Institutional Review Board