CITI Training Practice Exam

To which does 21 CFR 812.140 refer?

1. Biologics regulations

2. Device recordkeeping

3. Clinical trial conduct

4. Electronic signatures in clinical trials

The correct answer is: Device recordkeeping

21 CFR 812.140 refers to device recordkeeping. This is the section of the Code of Federal Regulations (CFR) that outlines the specific requirements for keeping records related to medical devices used in clinical trials. Option A refers to biologics regulations, which fall under a different section of the CFR (21 CFR 600-680). Option C relates to the general conduct of a clinical trial, which is covered in multiple sections of the CFR including 21 CFR 312 for investigational drugs and 21 CFR 812 for medical devices. Option D refers to electronic signatures, which is not specific to medical devices and is instead covered under 21 CFR 11 for electronic records and signatures. Therefore, the correct choice for this question is B because it is the only option that specifically addresses the topic of recordkeeping for medical devices in clinical trials.