May 23, 2012
from 01:00 PM to 04:00 PM
|Where||Brinkhous-Bullitt Building, Room 219|
|Contact Name||Lori Smith|
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This workshop will address the following information:
- Do I even need an IND for my investigation?
- What are some examples of trials requiring an IND and examples of 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
Filed under: CTSA