May 29, 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 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:
- 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).