May 30, 2014
from 01:00 PM to 04:00 PM
|Where||Brinkhous-Bullitt Room 219|
|Contact Name||Marie Rape|
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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:
- Regulatory Personnel
- Clinical Research Nurses
- Clinical Research Associates
This workshop is a CTSA collaboration by the NC TraCS (Translational and Clinical Sciences) Institute and the Duke Translational Medical Institute (DTMI).