For the sixth year consecutive year, IMARC is presenting its Top 10 Warning Letter findings for your review.
In April of 2015, the Food and Drug Administration released the BIMO metrics for 2014. These statistics are based on their findings after completing 1326 clinical research audits in the US and abroad. As a result of these audits, 42% (337 out of 803) of Clinical Investigators were found to have some type of deficiency. Of the issues noted, 13% received an official Form FDA 483 and thus were strongly encouraged to promptly implement corrective and preventative action plans. Listed below are the top ten Warning Letter findings for Clinical Investigators for the year 2014.
We see that the BIMO inspection findings are in line with the trends noted in previous years. Continued violations are noted in failing to follow the investigational plan, agreement, or IRB requirements, failure to obtain informed consent in accordance with the regulations, and inadequate subject protection.
Are you interested in looking back through our past warning letter whitepapers? They are also available to download off IMARC’s website.
Take time to download our 2018 Top 10 Warning Letters listing and compare to the previous year’s lists and let us know your thoughts.