Event Title | Investigational Device Exemption (IDE) Workshop |
Location | Brinkhous-Bullitt Building, Room 219, UNC-CH Campus |
Sponsor | NC TraCS (Translational and Clinical Sciences) Institute: NIH CTSA at UNC-CH |
Date/Time | 05/30/2014 1:00 PM - 4:00 PM |
This course will offer best practices when conducting trials using FDA approved and non-approved devices. It will cover the IDE application process and the obligations of the sponsor-investigator once the IDE application is filed with the FDA. This workshop will address the following information:
This course is designed for anyone directly involved in conducting investigator-initiated trials:
This workshop is a CTSA collaboration by the NC TraCS (Translational and Clinical Sciences) Institute and the Duke Translational Medical Institute (DTMI).
The IND and IDE Workshops have each been pre-approved for 3 Contact Hours of Clinical Research Education for re-certification of ACRP’s CCRC®, CCRA®, CPI®, at no cost. Certificates of attendance will be available at the conclusion of the training.