SAEs are reported to the sponsor on accelerated timelines (typically 24 hours for awareness). Sponsors integrate SAE data across sites to identify safety signals and submit IND safety reports when criteria are met.
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Glossary Term
Serious Adverse Event (SAE)
Data & Safety
Also known as: SAE, serious adverse events, serious AE
An adverse event that results in death, is life-threatening, requires hospitalization, causes persistent disability, or is otherwise medically important.
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