All terms
Serious Adverse Event
Adverse event resulting in death, life-threat, hospitalization, persistent disability, or congenital anomaly.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
An SAE per ISO 14155 is any AE that led to death; serious deterioration in health resulting in life-threatening illness or injury, permanent impairment, in-patient hospitalization, or medical/surgical intervention; or fetal distress or congenital anomaly.What this means in practice
Sponsors must report SAEs and SADEs to regulators and IRBs/ECs within defined timeframes (often 7 or 15 days depending on jurisdiction and seriousness).Cross-references
Part of
A larger framework or document this term belongs to.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
ISO·1FDA·1NIH·1
- 1
ISO 14155:2020VerifiedISOiso.org
- 2
FDA - Clinical Trials and Human Subject ProtectionVerifiedFDAfda.gov
- 3
ClinicalTrials.govVerifiedNIHclinicaltrials.gov
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