Clinical & Trials
Adverse Event(AE)
In one line
Any untoward medical occurrence in a subject, whether or not related to the device.
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.
ISO 14155 asks sponsors to record all adverse events in a device investigation and to assess each for seriousness and for relationship to the device or procedure. Adverse device effects are the subset related to the device. Clinical investigation plans define how events are collected, coded (often with MedDRA) and adjudicated, and the results feed safety reporting and the final clinical investigation report.
Why it matters
AEs are the foundational unit of clinical safety reporting. Serious AEs (SAEs) and device-related AEs (ADEs/SADEs) trigger expedited reporting obligations.
Common pitfalls
- •Confusing an adverse event with a device malfunction that did not lead to an adverse clinical outcome, as these have distinct reporting pathways.
- •Failing to initiate an investigation or report an adverse event due to a perceived lack of direct causal link to the device, as all untoward occurrences must be assessed.
- •Delaying the reporting of serious adverse events (SAEs) beyond the mandated regulatory timelines, which can lead to non-compliance.
- •Not adequately documenting the assessment of causality between the device and the adverse event, which is critical for regulatory review.
- •Inconsistently applying definitions of "serious" across different studies or reporting jurisdictions, causing reporting errors.
Sources