Required under 21 CFR 312.32, IND safety reports must be submitted on accelerated timelines (7 days for fatal/life-threatening unexpected reactions; 15 days for other qualifying reports) and shared with all participating investigators.
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Glossary Term
IND Safety Report
Data & Safety
Also known as: IND safety reports, 312.32 report
A sponsor report to FDA of serious, unexpected, suspected adverse reactions and certain other safety findings in an IND study.
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