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Clinical Data Integrity: Clean US FDA Inspection No Guarantee That DoJ Won’t Investigate

 
• By Sue Sutter

Justice department has investigative tools that can uncover fraudulent activity even when a clinical site passes inspection, DoJ’s Clint Narver says; in deciding whether to self-report possible clinical trial fraud to FDA and DoJ, sponsors should consider that other companies would benefit from knowing this information about a particular site or investigator.  

Escalator
Drug sponsors need to have clear processes in place for escalating concerns about clinical data fraud. • Source: Shutterstock

A “glowing” US Food and Drug Administration inspection may not protect a pharmaceutical sponsor, contract research organization or site investigator from a Department of Justice investigation into potential clinical trial fraud.

Although DoJ looks at an entity’s inspectional history, that may not tell the full story in terms of whether fraud...

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