שאלה משלב א׳ בבריאות הציבור · מועד 2022, שאלה 104

In a clinical trial, THE SEVERITY of an adverse event is graded BY THE INVESTIGATOR (mild, moderate, severe), separately from its 'seriousness', which is a regulatory definition (death, life-threatening, hospitalisation, persistent disability, congenital anomaly or an important medical event). A serious adverse event need not be severe nor fatal, and reporting timelines are defined by regulation (24 hours for a fatal or life-threatening unexpected suspected reaction, 7 or 15 days otherwise).