08 Mar Adverse event record template

Adverse event (AE) refers to any adverse medical event that occurs after the administration of the test drug, which does not necessarily have a causal relationship with the treatment of the drug. An adverse event can be any unprofitable or unexpected sign (including abnormal laboratory results), symptom or disease that has a time-dependent relationship with the administration of the trial drug, whether or not there is a causal relationship with the treatment of the drug. This includes events that did not exist before treatment, that occurred during treatment, or that were more severe than before treatment.

Serious adverse event (SAE) refers to the serious events such as prolonged hospital stay, disability, affecting work ability, life-threatening or death in the process of clinical trial, regardless of the relationship with clinical medication.