SOCRA CCRP Practice Exam

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What FDA regulations govern continuing review reports?

21 CFR 312.33
21 CFR 812.150(b)(5)
21 CFR 314.80
21 CFR 806.10

The correct answer is: 21 CFR 312.33

Answer FDA regulations for clinical trials are covered under 21 CFR 312. In particular, 21 CFR 312.33 covers the requirements and procedures for submitting continuing review reports to the FDA. The other options are not directly related to clinical trials: 21 CFR 812.150(b)(5) pertains to the responsibilities of sponsors of medical device studies; 21 CFR 314.80 covers post-marketing responsibilities for drug products; 21 CFR 806.10 is for medical device manufacturer reporting requirements.