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

This course is designed for anyone directly involved in conducting investigator-initiated trials:

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

Speakers:

• Erika Segear Johnson, PhD RAC (Duke)
• Amy Franklin, BS (UNC)

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 Points of Clinical Research Related Education on application for maintenance of ACRP’s CCRC®, CCRA®, CPI® certification designations. Certificates of attendance will be available at the conclusion of the training.