Investigational New Drug (IND) Workshop

When May 29, 2014
from 01:00 PM to 04:00 PM
Where Brinkhous-Bullitt Room 219
Contact Name
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This course will offer best practices when conducting clinical trials using FDA approved and non-approved drugs or substances (including botanicals and biologics). It will cover the IND process and the regulatory obligations of the sponsor- investigator once an IND is filed with the FDA. This workshop will address the following information:

  • Do I need an IND for my investigation?
  • Provide examples of trials requiring an IND and studies that are IND exempt
  • What should I include in my IND submission to the FDA?
  • What happens after I submit my IND application to the FDA?
  • How and when should I report Serious Adverse Events (SAEs) once I have an IND?
  • Is my trial required to be registered on Clinicaltrials.gov?
  • Roundtable discussion about the IND process and general questions from participants

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

  • Investigators
  • 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).

More information about this event…