AEs and SAEs In Clinical Research in Under 2 Minutes

Generally speaking, adverse events are medical occurrences that happen after a patient signs an ICF. An AE may range from falling or developing an illness but must be recorded by the site. If the event is an SAE then the patient has most likely experienced a hospitalization or death. After all data is collected, the PI must make a determination regarding the cause and severity of an AE and SAE.