Clinical Investigators Cited for Protocol Deviations in 483s

July 12, 2016

Three clinical investigators were cited for deviating from their investigational plans recently by the FDA for a litany of different reasons.

The FDA issued a Form 483 to Brian Driver of Hennepin County Medical Center for failing to report three patient deaths after experiencing serious adverse effects. The serious adverse effects had not been documented, reviewed or evaluated, as required by protocol, inspectors noted.

Inspectors also reported discrepancies in Driver’s evaluation of adverse effects, with certain events that should have been categorized as life-threatening being documented as moderate, according to the 483.

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