When the Food and Drug Administration (FDA) identifies significant findings with the conduct of a clinical trial during an inspection, what happens to those findings? According to a recent article published online by JAMA Internal Medicine, those findings remain hidden in plain sight.

This week is FDA Warning Letter Week at IMARC! Have you had a chance to catch up on the first three blogs that aim to help you response to the FDA? This last blog in the series attempts to take the perspective of the agency when reading your response letters.

This week is FDA Warning Letter Week at IMARC! Did you check out the first two blogs in a series of 4 titled Differences and similarities between FDA Warning Letters and Form 483s and Tips to avoid when responding to FDA Warning Letters and Form 483s? Next learn 10 Tips to consider when responding to a FDA Warning Letter or Form 483:

One way that the Food and Drug Administration (FDA) protects public health and ensures compliance with the Food, Drug and Cosmetic Act is by conducting inspections of clinical trial investigators, clinical trial sponsors, Institutional Review Boards (IRB) and facilities that manufacture, process or pack FDA-regulated products.  At the conclusion of an investigation, a site may be issued a Form 483 or a Warning Letter. Read on to learn the differences and similarities of these forms of communication provided by the FDA to the inspection site.

This week is FDA Warning Letter Week at IMARC Research!  Over the next four days, IMARC will provide the following blogs to help learn and generate conversation:

The 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?

In clinical research this phrase is used to emphasize the importance of complete and accurate documentation to site staff.  Still, every year we see that FDA issues multiple warning letters which cite, “You failed to maintain adequate and accurate records.”

While working on a recent project involving researching FDA warning letters, it astonished me the number of investigators and investigative sites who had issues with informed consent.  I was surprised at the seemingly little familiarity study staff had regarding Federal Regulations when it came to the informed consent and the consenting process.

In thinking about working with sites to prepare for a potential FDA audit, we reviewed several of the recent FDA warning letters which had been sent to sites after audits were conducted.

Dr. K. Kringle
Adjunct Professor of Child Psychology
Far Northern University