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    Adverse Event

    Any untoward medical occurrence in a subject, whether or not related to the device.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Per ISO 14155, an adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational device.

    What this means in practice

    AEs are the foundational unit of clinical safety reporting. Serious AEs (SAEs) and device-related AEs (ADEs/SADEs) trigger expedited reporting obligations.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·1FDA·1NIH·1
    1. 1
      ISO 14155 AE definitions
      Verified
      ISOiso.org
    2. 2
      FDA - Clinical Trials and Human Subject Protection
      Verified
      FDAfda.gov
    3. 3
      ClinicalTrials.gov
      Verified
      NIHclinicaltrials.gov

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