Full course description
Tuesday, October 29th, 2019, 2:00PM - 4:00PM, Health Sciences Education Building (HSEB), Room 2110
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.