Serious adverse event

A serious adverse event ( SAE) (of English. Serious adverse event, SAE ) is a serious incident that occurs in the context of a clinical trial of drugs or medical devices in a patient or subjects. At first, does not matter whether the SUE stands in a causal relationship with the study or not; the only decisive factors of the temporal context.

According to GCP and German Medicines Act or law for medical products all adverse events are considered to be severe, the:

• In death of a test result
• Are immediately life threatening
• Make an unforeseen hospitalization or prolongation of hospitalization required
• Draw a congenital anomaly or birth defect according to
• Have a permanent or severe disability or incapacity result

If a SAEs, the investigator the sponsor of the study must be notified immediately. There is suspicion of a causal relationship with the test substance or the test methods and can not be classified as expected the event, the sponsor of the study is required to inform all relevant health authorities and all relevant ethics committees and the agency responsible for pharmacovigilance department of the respective publishers of to set the SUE in knowledge. In addition, the GCP Regulation also prescribes a detailed documentation of the SUE.

To the attention of a wider public got the occurrence of SUE, as in spring 2006 in London six previously healthy volunteers critically ill after they had been administered previously considered harmless substance classified TGN1412 in the context of clinical trials.