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  • Lorrie D. Divers, President, QRCP Solutions, Inc.

Heed the Warning (Letters)

I found a recent FDA Warning Letter issued to a Clinical Investigator for a pediatric flu vaccine study quite interesting. A few points I found particularly notable:

The first violation cited may have potential implications for Interactive Response Technologies (IRT) as it appears the site randomized but did not actually consent or vaccinate several subjects. If you are involved in IRT, I would be very interested in your thoughts on this.

Next, there are a number of detailed observations with regards to protocol compliance and on the topic of case histories (source documents versus CRFs). It shows the depth of the FDA's review during an inspection and how such discrepancies are considered regulatory non-compliance.

Finally, the Clinical Investigator appears to have provided a well-constructed action plan in response to the 483 because for the most part, the FDA has indicated that the corrective actions, "if implemented as described" were considered "adequate."

Take a look at the full Warning Letter and let me know your thoughts:

Let’s start a conversation! Follow QCRP Solutions, Inc. on LinkedIn for more quality assurance, regulatory compliance and process excellence topics. Contact me at to learn more about our services.

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