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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 John Lehmann on Wed, Mar 04, 2015

The Difference is in the Details: Drugs vs. Devices

IMARC Research’s whitepaper investigates the differences between the drug and medical device clinical research process.  First and foremost, there is a common thread that ties the seemingly different clinical research processes together…patients.  Real people exist on the other side of an investigational product and they face risk when they choose to take part in a clinical research study.  So while the investigations of drugs and devices have their differences, by design these differences are intended to accomplish the game goal:  to safeguard those research participants while bringing safe and effective products to the market as quickly as possible.

Topics: Sandra Maddock, Drugs vs. Devices, Clinical Reearch

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Clinical Research Training Requirements
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clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.