ICON Warning Letter from the FDA

keep the investigational medicinal product secure in a clinical trial

Please check out a recent warning letter sent to ICON Clinical Research in regards to monitoring services they provided for two antibiotic trials.

Routine Inspections Triggered Serious Findings

My understanding is that the sponsor submitted the NDA, triggering routine inspections, and the CRO has now been asked to respond to a series of serious findings.  There were reportedly issues in regards to storage/dispensing of investigational product, protocol deviations, incomplete source documents, inadherence to the monitoring plan, and insufficiency in monitoring oversight.  It is a very detailed letter and appears to question whether 100% Source Data Verification was completed properly with a series of concrete examples of discrepancies.  As monitors, we need to comply with all regulations and stay abreast of these kinds of relevant FDA findings – hope you will find reading the warning letter as helpful as I have.  Here is the link again: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm193156.htm

About The Author

The Lead CRA

Nadia started The Lead CRA blog in 2007. She is now lead author for ClinOps Toolkit. Nadia is currently working as a Clinical Program Manager at a small specialty pharmaceutical company in the San Francisco Bay Area. You can reach Nadia via email at [email protected] anytime.

1 Comment

  • Anonymous

    January 8, 2010

    Thanks for posting this. It seems really familiar; like one sent to a pharma last year.

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