Serious adverse event

An Adverse Event (AE) is an adverse event (UE) that occurs in the temporal context of a clinical trial. In principle, a distinction can be made according to the severity of the event in:

• Adverse Event and
• Serious Adverse Event (SAE).

According to the GCP Ordinance or the Medical Devices Act (MPG) and the German Medicines Act (AMG), a Serious Adverse Event is to be assumed if a death of the patient, a life-threatening situation, a hospital extension or permanent damage to the patient or congenital anomalies occur.

If a Serious Adverse Event occurs or is suspected, a report must be made to the sponsor and the authorities(ethics committee, higher federal authority). The obligation to report is independent of whether the investigational product or the investigational medicinal product caused the Serious Adverse Event.

An assessment is made by the investigator as to whether the SAE was caused by the trial or whether it occurred independently. In randomized trials, this assessment is usually made without the investigator knowing whether the patient took the verum or placebo. In severe serious serious adverse events with acute risk to the patient, emergency unblinding may be performed if this affects the patient's further treatment.