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Posted by Mary Lewis on Wed, Jan 27, 2016

21 CR 812.100: A Medical Auditor's Favorite Regulation

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.

Topics: Investigator Responsibilities, Clinical Reearch, FDA, 21 CR 812.100

Posted by Mary Lewis on Wed, Mar 04, 2015

A Medical Device Clinical Auditor’s Favorite Regulation: 21 CR 812.100

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.

Topics: 21CFR812.100, Investigator Responsibilities, Clinical Auditing, FDA, Clinical Research

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