Serious Adverse Event
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.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).Examples
- A participant in a clinical trial for a novel cardiac stent experiences a myocardial infarction leading to emergency hospitalization, which is classified as a Serious Adverse Event.
- A subject using an investigational continuous glucose monitor develops severe hypoglycemia requiring intervention, meeting the definition of a Serious Adverse Event due to serious deterioration in health.
- During a clinical study, a participant succumbs to an unforeseen illness unrelated to the investigational device, but because it resulted in death, it is still reported as a Serious Adverse Event by the study sponsor.
- •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.
Frequently asked questions
Cross-references
Part of
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsAny untoward medical occurrence in a subject, whether or not related to the device.
Good clinical practice for clinical investigations of medical devices.
Reporting and management of serious incidents and field safety corrective actions.
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Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1ISO 14155:2020Tier 1 VerifiedISOiso.org
- 2FDA - Clinical Trials and Human Subject ProtectionTier 2 VerifiedFDAfda.gov
- 3ClinicalTrials.govTier 3 VerifiedNIHclinicaltrials.gov
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