SOCRA CCRP Practice Exam

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Which regulations dictate adverse event and serious adverse event reporting?

21 CFR 312.32 and 21 CFR 812.46
21 CFR 314.80 and 21 CFR 600.80
21 CFR 210 and 21 CFR 211
ICH E6 and ICH E2A

The correct answer is: 21 CFR 312.32 and 21 CFR 812.46

21 CFR 312.32 and 21 CFR 812.46 specifically address adverse event and serious adverse event reporting in clinical trials under the FDA. Option B (21 CFR 314.80 and 21 CFR 600.80) relates to post-marketing reporting for drug and biologic products, but does not cover clinical trials. Option C (21 CFR 210 and 21 CFR 211) refer to general good manufacturing practice regulations, not reporting requirements. Option D (ICH E6 and ICH E2A) are international guidelines, but do not have the same legal authority as FDA regulations. Therefore, these options are not as relevant to adverse event and serious adverse event reporting as option A.