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Preparation for Investigator-Initiated Drug and Device Studies - October 7th is a Course

Preparation for Investigator-Initiated Drug and Device Studies - October 7th

Oct 7 - Oct 10, 2020

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Full course description

Wednesday, October 7, 2020 2:00pm - 3:00pm, Zoom

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.

 

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