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.
Event details
When
May 18, 2011 12:00 AM
to
May 19, 2011 12:00 AM
May 19, 2011 12:00 AM
Where
Brinkhous-Bullitt Building, Room 219
Contact Name
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.
