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Compliance In Focus
Posted by Mary Lewis on Mon, Sep 22, 2014

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” federalA Medical Device Clinical Auditor%27s Favorite Regulations 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. 

Investigators are responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan, applicable FDA regulations and for control of investigational product. 

It further details that investigators are responsible for protecting the rights, safety and welfare of subjects by ensuring that informed consent is obtained in accordance with 21 CFR Part 50 regulations. 

IMARC publishes an annual whitepaper detailing the top 10 FDA Warning Letter citations as published on FDA’s website.  These letters result from regulatory violations observed during BIMO inspections that meet the “official action indicated” threshold.  The top findings repeat year after year and some examples include:

  • Failure to promptly report all research activity changes to the IRB
  • Failure to protect the rights, safety and welfare of subjects
  • Failure to maintain adequate and accurate case histories on each individual administered investigational product or employed as a control in an investigation
  • Failure to personally supervise the clinical investigation
  • Failure to ensure that the investigation was conducted according to the investigational plan

The over arching goal of FDA’s BIMO Program is to improve the quality of clinical trial conduct specifically focusing on data integrity and protection of human subjects.  Please check out the resources on our website and think about how the studies you work on would compare to these observations and my favorite regulation.  I would be interested in hearing about your experiences and efforts to raise the quality bar in clinical research conduct.

Photo Credit: monsieurlam

FDA Regs vs ISO Whitepaper

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


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