I am often asked by industry colleagues that if I had to pick just one “favorite” federal regulation what would it be? The answer is easily 21 CFR 812.100, as this regulation embodies 95% of the investigational site non-compliances I observe as I conduct clinical investigator audits. Let me elaborate.
21 CFR 812.100 falls under Subpart E- Responsibilities of Investigators of the IDE Regulations. This regulation succinctly details investigator responsibilities in just two sentences.