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Top 10 2011 FDA Warning Letter Findings for Clinical Investigators


Top 10 2011 FDA Warning Letters

After reviewing warning letters issued to investigators and sponsor-investigators last year, through FDA’s Bioresearch Monitoring Inspection Program, IMARC’s clinical monitoring team has assembled the 2011 “TOP 10” 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.

As in years past, many of the findings focus around:

  • Protocol compliance
  • Human subject protection
  • Record keeping
  • Study oversight

It’s interesting that the most common findings have not changed significantly in years past. Check out IMARC’s “Top Ten” lists for 2009 & 2010. 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.

Take time to compare all three lists and let us know what you think.


FDA warning letters sometimes cite a failure to do something not required by the referenced regulation. 21 CFR 312.62(a) does not require a record of drug transfer from one site to another. 
You failed to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects [21 CFR 312.62(a)]. 
a. ... 
b. During the inspection, you and your staff informed Investigator Tait that the investigational drugs were stored at one office, and were transported to another office, where the subjects received the drugs. However, there are no records to document this transfer of the investigational drugs.
Posted @ Wednesday, March 07, 2012 7:24 AM by Shirley Isbill
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