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

Preparation for Investigator-Initiated Drug and Device Studies

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THIS LISTING IS THE TBA SESSION OF THIS CLASS. To be notified when a session of this class is scheduled, or if you cannot attend the already scheduled course, please enroll in this class.

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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