SOCRA CCRP Practice Exam

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What FDA regulations govern SAE reporting?

  1. 21 CFR 312

  2. 18 CFR 200

  3. 10 CFR 50

  4. 29 CFR 1910

The correct answer is: 21 CFR 312

Explanation FDA regulations governing SAE (Serious Adverse Event) reporting are found in 21 CFR 312. Options B, C, and D do not pertain to FDA regulations for SAE reporting. Option B refers to eligibility for electricity and option D refers to general industry safety standards. Option C refers to nuclear reactor safety.

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