| An Adverse Event (AE) is any untoward medical occurrence during a clinical trial. It is irrelevant whether the AE is related to the use of an investigational drug or a medical device. The study doctor records the symptoms of the AE, the severity, the first occurrence, and the end as well as countermeasures in the patient chart and the CRF (Case Report Form for clinical trials). The documentation periods for a non-serious AE are determined in the protocol. Strict reporting deadlines apply in the case of a Serious Adverse Event (SAE). |
Deutsche Erklärung |
