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Compliance In Focus
Posted by John Lehmann on Tue, Feb 12, 2013

Top 5 FDA Warning Letters for 2012

Our annual report announcing the Top 5 Warning Letter Findings for Clinical Investigators forTop 5 FDA Warning Letters for 2012 2012 is hot off the press! Take the time to download and read IMARC’s newest whitepaper “2012 Top 5” list. This list is not intended to point fingers at investigators, but rather, to document the non-compliance trends in an effort to raise industry awareness of improvement needed. Whether you are a sponsor, a monitor, or an investigative site, everyone has a stake in the outcome of an FDA BIMO inspection.

Check out IMARC’s warning letter “report card” and download our newest whitepaper now!

The warning letters of the past several years reveal familiar trends in the violations uncovered during BIMO Audits. A common theme is failure to follow:

  • The agreement
  • The investigational plan or
  • The regulations stipulated by IRB, FDA or the state

Keeping these items in mind when planning your next project will help to keep your study team focused on compliance and may help prevent your team from repeating the same mistakes. Incorporating warning letter review into your regular staff trainings is a good way to start the hard discussions, brainstorm ideas, and better equip your staff to cultivate compliance among clinical research sites.

Well-run, compliant studies result from well-trained staff. And of course, maintaining compliance ensures patients are protected and data has integrity, so when a new drug or device hits the market, we can be confident that it belongs there.

Are you surprised at any of the findings? Or, did you notice the recent trend of non-compliances? How can we improve as an industry? Share the steps you think we need to take to keep from making the same mistakes.

Top 10 FDA Warning Letter Findings, 2011

Topics: Non-Compliance, 2012, FDA Warning Letters


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