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Compliance In Focus
Posted by Lauren Easley on Tue, Feb 25, 2014

2013 Top FDA Warning Letter Findings

For the fifth year, IMARC has searched through the warning letters posted on the FDA’s websiteTop 2013 Warning Letters to compile a list of the top findings for clinical investigators. This year, we noted twelve warning letters that were issued in 2013. In the past years, the most common citings tend to revolve around failure to follow the clinical investigational plan, insufficient recordkeeping, and inadequate subject protection. Interested to see if the trends continued for 2013?

Take a look at IMARC's new whitepaper.

We also took a look at the top findings for Sponsors and Institutional Review Boards. Five warning letters were reviewed for IRBs and one for a Sponsor.

No matter whether you work for a sponsor, CRO, or site; there are many lessons one can learn from studying the citations. They provide a valuable “report card” of the clinical research industry and also give the industry insight into the current thinking of the FDA. Keeping the findings in mind when you start your next project can help positively impact compliance from day one.

Interested in looking back through our past warning letter whitepapers? They are also available to download off IMARC’s website (2009, 2010, 2011, and 2012).

Were any of the citations noted in the whitepaper a surprise to you? What plans do you take away from the letters to affect compliance at your own institution? Let us know your thoughts in the comments below.


Topics: Sponsors, FDA Warning Letters, IRBs, IMARC Research


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