NC TraCS IND/IDE Workshops

Calling all Investigators, Regulatory Personnel, Clinical Research Nurses and Clinical Research Associates (CRAs)! This two-day course will offer best practices when conducting clinical trials using FDA approved and non-approved drugs or devices. It will cover the IND/IDE process and the regulatory obligations of the sponsor- investigator once an IND/IDE is filed with the FDA.

When May 18, 2011 12:00 AM to
May 19, 2011 12:00 AM
Where Brinkhous-Bullitt Building, Room 219
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Some of the topics for discussion will be:

  • Do I even need an IND or IDE to conduct my research?
  • Examples of when an IND or IDE may be required
  • What should be included in my IND or IDE application?
  • How do I report a serious adverse event (SAE) when I have an IND or IDE?
  • Is my trial required to be registered on Clinicaltrials.gov?

We have divided this workshop into 2 days.  You may sign up for either the IND, IDE or both workshops, depending on your specific interests and investigational needs.

More information about this event…