Investigational Device Exemption (IDE) Workshop

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. Speakers include Erika Segear Johnson, PhD RAC (Duke) and Amy Franklin, BS (UNC).

  • Investigational Device Exemption (IDE) Workshop
  • 2015-11-05T12:00:00-05:00
  • 2015-11-05T15:00:00-05:00
  • 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. Speakers include Erika Segear Johnson, PhD RAC (Duke) and Amy Franklin, BS (UNC).
When Nov 05, 2015 from 12:00 PM to 03:00 PM (EST / UTC-500)
Where Brinkhous-Bullitt, Room 219
Contact Name
Contact Phone 919.843.9636
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These course are designed for anyone directly involved in conducting investigator-initiated trials:

  • Investigators
  • Regulatory Personnel
  • Clinical Research Nurses
  • Clinical Research Associates

IDE Workshop

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:

  • Definition of a medical device
  • Examples of when an IDE is required by the FDA
  • What are PMA, 510k, and other terms used in device regulations?
  • What is an abbreviated IDE and when is this applicable?
  • What is the difference between an abbreviated IDE and a “full” IDE and when is the “full” IDE applicable?
  • How do I submit my IDE application to the FDA?
  • How do I maintain the IDE once it’s filed with the FDA?
  • How and when should I report Serious Adverse Events (SAEs) once I hold the IDE?
  • Is my trial required to be registered on Clinicaltrials.gov?
  • Roundtable discussion about the IDE process and general questions from participants

Speakers: Erika Segear Johnson, PhD RAC (Duke) and Amy Franklin, BS (UNC)

Details and registration

These workshops are a CTSA collaboration by the North Carolina Translational and Clinical Sciences (NC TraCS) Institute and the Duke Translational Medical Institute (DTMI).