CCRA - Certified Clinical Research Associate Practice Test
CCRA Adverse Event Management
What distinguishes a Serious Adverse Event (SAE) from a non-serious adverse event?
Select your answer
A
An SAE is any adverse event reported by the subject
B
An SAE results in death, is life-threatening, requires hospitalization, results in disability, or involves a congenital anomaly
C
An SAE must always be caused by the investigational product
D
An SAE requires statistical significance to be classified as serious
Hint
