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Compliance In Focus
Posted by Sandra Maddock on Tue, Mar 26, 2013

FDA Releases BIMO Metrics for 2012

FDA Releases BIMO Metrics for 2012The FDA Bioresearch Monitoring Program (BIMO) was created to: “Protect the rights, safety, and welfare of human research subjects involved in FDA-regulated clinical trials; Verify the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications; and To assess compliance with statutory requirements and FDA's regulations governing the conduct of clinical trials.” But, how exactly does FDA safeguard human subjects, ensure data integrity, and verify compliance with applicable standards?

FDA uses Compliance Program Guidance Manuals (CPGM) to conduct site visits to any/all of the parties involved in the clinical research process (Clinical Investigators, Sponsors/Monitor/CRO, IRB’s, etc.) to help achieve BIMO objectives. The result of these inspections can go one of three ways:

  • No Action Indicated (NAI)
  • Voluntary Action Indicated (VAI), or
  • Official Action Indicated (OAI)

The third category above results in what FDA terms a Warning Letter, or written correspondence that notifies whoever was inspected of the violations FDA noted during the inspection.  FDA posts the warning letters to their website, making them available to the public for review.  Each year, FDA also publishes BIMO Metrics- a summary of the inspections conducted and the results of the inspections broken down by category (i.e. Clinical Investigators, Sponsor/Monitor/CRO, IRB, etc.).  The Metrics also summarize the most common deficiencies for each.

At IMARC we focus heavily on the Warning Letters that are posted to the website to review findings, determine trends, and to ensure we are assisting sites and Investigators to avoid similar findings.  Similar to how FDA releases the BIMO Metrics each year, we publish a Top 10 (or in this year’s case, Top 5) List of common deficiencies by reviewing the warning letters that are posted on the FDA website.  This was done just prior to when FDA releases the Metrics, which provides the perfect opportunity for comparison once released.  Of note, our findings are based on the Warning Letters that are posted in that calendar year, and not necessarily on the inspections that happened that year (there is often some lag time between the time of inspection and the time the letter is issued and posted for review).  Because of this, our tally may be slightly different, although a comparison of years past shows similar results.

Here’s how IMARC’s Top 5 List compares with FDA’s Metrics for 2012:

Most Common Deficiency

IMARC

FDA

Failure to follow the investigational plan and/or regulations

X

x

Protocol Deviations

x

x

Inadequate recordkeeping

x

x

Inadequate accountability for the investigational product

 

x

Inadequate communication with the IRB

x

x

Inadequate subject protection – including informed consent issues

x

x

Not only does our manual look through the Warning Letters give us a good summary of the findings for the year, it also illustrates the fact that the findings are not changing much from year to year.  Aside from “Inadequate communication with the IRB” coming in as a finding in 2011, the findings have not changed, and the same issues are cited over and over.

How do you use the BIMO metrics in your role?  Share your experiences with us.

Photo Credit: RambergMediaImages

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Topics: BIMO Metrics, IMARC Research, FDA, Warning Letters

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