- 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).
|When||Nov 05, 2015 from 12:00 PM to 03:00 PM (EST / UTC-500)|
|Where||Brinkhous-Bullitt, Room 219|
|Contact Name||Donna L. Polat|
|Web||Visit external website|
|Add event to calendar||iCal|
These course are designed for anyone directly involved in conducting investigator-initiated trials:
- Regulatory Personnel
- Clinical Research Nurses
- Clinical Research Associates
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)
These workshops are a CTSA collaboration by the North Carolina Translational and Clinical Sciences (NC TraCS) Institute and the Duke Translational Medical Institute (DTMI).