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The requirement for investigators to keep records of deviations from the approved protocol is specifically stated in 21 CFR 812.140(a)(4). This regulation pertains to clinical investigations of devices. It mandates that investigators maintain accurate records of all protocol deviations, which is crucial for ensuring the integrity of the study and the safety of participants. This requirement serves to foster transparency and rigor in clinical trials, as documenting deviations allows for proper oversight and evaluation of the study’s conduct.

In contrast, while other regulations and guidelines may touch on aspects of clinical research compliance and reporting, they do not specifically address the record-keeping of protocol deviations. For example, 21 CFR 312.64 primarily outlines the responsibilities for maintaining records of clinical investigations of drugs but does not specifically mention protocol deviations. The ICH GCP guideline focuses on overarching principles of Good Clinical Practice but does not impose the record-keeping requirement about deviations as explicitly as 812.140(a)(4). Similarly, 21 CFR 50.25 relates to informed consent requirements and does not cover deviations directly. Therefore, the correct answer is based on explicit regulatory language that identifies the documentation of protocol deviations as a key component in the context of device clinical trials.