Serious adverse event (SAE)

A serious adverse event (SAE) means any untoward medical occurrence that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, is life-threatening, or results in death (Art. 2(2)(33) EU Clinical Trials Regulation 536/2014; ICH E2A). Other important medical events may be judged serious by the investigator. Seriousness is a regulatory classification based on outcome and must not be confused with severity, which grades intensity.

Under Art. 41 CTR the investigator must report all SAEs to the sponsor without undue delay and within 24 hours of becoming aware, unless the protocol exempts certain events. The sponsor assesses causality and expectedness against the reference safety information in the investigator's brochure; suspected unexpected serious adverse reactions (SUSARs) are reported to EudraVigilance within 7 days (fatal or life-threatening) or 15 days (other), and all SAEs are summarised in the annual safety report under Art. 43.

SAE reports contain detailed clinical narratives, medical history, concomitant medications and outcomes for an identified subject, often with dates and hospital details that increase identifiability. They are health data processed under legal obligation and public health (Art. 6(1)(c) and 9(2)(i) GDPR), exempt from the right to erasure and retained for the life of the product. The safety database vendor and the CRO's pharmacovigilance unit act as processors; transfers to non-EU sponsors, partners and regulators must be covered by appropriate safeguards or the public-interest derogation, and narratives should be written with only the information necessary for medical assessment.