SOCRA CCRP Practice Exam

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Under which FDA regulation are investigators required to keep records of deviations from protocol?

21 CFR 312.64
21 CFR 812.140(a)(4)
ICH GCP guideline, section 8
21 CFR 50.25

The correct answer is: 21 CFR 812.140(a)(4)

Under 21 CFR 312.64, investigators are required to keep accurate and complete records of all investigational drugs received, administered, or dispensed. This regulation does not specifically mention deviations from protocol. Under 21 CFR 812.140(a)(4), investigators are required to keep records of all deviations from the investigational plan (protocol). This option is correct because it specifically mentions deviations from protocol. The ICH GCP guideline, section 8, also discusses record keeping requirements for clinical trials, but it does not specifically mention deviations from protocol. Under 21 CFR 50.25, investigators are required to obtain and document informed consent from the trial participants. This option is incorrect as it does not pertain to record keeping of deviations from protocol.