CCRA® — Certified Clinical Research Associate

What distinguishes a Serious Adverse Event (SAE) from a non-serious adverse event?

An SAE is any adverse event reported by the subject An SAE results in death, is life-threatening, requires hospitalization, results in disability, or involves a congenital anomaly An SAE must always be caused by the investigational product An SAE requires statistical significance to be classified as serious

Correct Answer:

An SAE results in death, is life-threatening, requires hospitalization, results in disability, or involves a congenital anomaly

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