Clinical & Trials
Serious Adverse Event(SAE)
In one line
Adverse event resulting in death, life-threat, hospitalization, persistent disability, or congenital anomaly.
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.
Serious adverse events must be reported promptly. Under MDR Article 80 and MDCG 2020-10/1, sponsors report reportable SAEs to the competent authorities of all member states running the investigation, within set timeframes as short as two days for events suggesting imminent risk. In the US, unanticipated adverse device effects must reach FDA and IRBs within 10 working days under 21 CFR 812.150.
Why it matters
Sponsors must report SAEs and SADEs to regulators and IRBs/ECs within defined timeframes (often 7 or 15 days depending on jurisdiction and seriousness).
Common pitfalls
- •Confusing a Serious Adverse Event with an Adverse Event, which has different reporting criteria.
- •Failing to report a Serious Adverse Event within the mandated timeframe, leading to non-compliance.
- •Misinterpreting the criteria for "serious deterioration in health" or "life-threatening illness or injury."
- •Not having a clear internal procedure for identifying, documenting, and reporting Serious Adverse Events.
- •Failing to track all required data elements for a Serious Adverse Event report.
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