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 If your research is done under an IND or IDE, you must notify NIAID in writing if the FDA places your study on clinical hold. If it's not done under an IND or IDE, you and NIAID jointly determine safety reporting requirements.
IND and IDE sponsors must notify FDA about serious adverse events through safety
reports and provide copies to the NIAID program or project officer within
24 hours of FDA notification. These include:
Report other adverse events you document during the trial in the annual IND or IDE report.
If we have an issue, your program or
project officer will let you know within ten working days by email
or fax, followed in 30 days by an official letter.
For more information, read the Guidance
on Reviewing and Reporting Unanticipated Problems Involving Risks to
Subjects or
Others and Adverse Events issued by the Office
for Human Research Protections.
Additional Resources
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