(CCA) CATO Certified Associate Practice Test
CCA CATO Associate Safety Reporting & Adverse Events
What is the definition of a Serious Adverse Event (SAE) in clinical trials?
Select your answer
A
Any adverse event that causes mild discomfort
B
An adverse event that results in death, is life-threatening, requires hospitalization, causes persistent disability, or is a congenital anomaly
C
An adverse event that requires dose reduction only
D
Any event reported by the subject regardless of severity
Hint
