FDA warning letters: Findings for clinical investigators

Each year the Food and Drug Administration (FDA) releases metrics on the Bioresearch Monitoring (BIMO) Program. The purpose of the BIMO program is to inspect FDA-regulated clinical trials to ensure the rights, safety and welfare of human research subjects have been protected and that the validity of research data is accurate to support a marketing application. When serious violations are found during a BIMO inspection, a warning letter is issued. These BIMO inspection metrics provide the common findings that are found during these inspections by fiscal year (FY). According to the United States federal government, the FY begins on October 1^st of the previous calendar year and ends on September 30^th, the year in which it is numbered.

In FY’15, over 1,077 BIMO Inspections were conducted on Clinical Investigators (CIs), Institutional Review Boards (IRBs) and Sponsors/Monitor/Contract Research Organizations (CRO). As a result of these inspections, 36% of CIs, 41% of IRBs, and 39% of Sponsors/Monitors/CROs were found to have either voluntary or official action indicated.

To review FY’15 top findings in more detail for CIs, check out IMARC’s new whitepaper

You will notice that these findings over the past years have not changed, which is why it is important for you to be aware of them. Whether you are a CI, the Chair of an IRB, or a Sponsor, the underlying question is, how prepared are you for a BIMO inspection? Find out how IMARC can help prepare you here.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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