Investigator Admits Ignoring Trials, Receives FDA Warning

A principal investigator who confessed to disregarding her trial responsibilities received an FDA warning for “systemic failures” in trial conduct that include failing to personally execute or adequately oversee two trials, as well as protocol deviations.

The investigation revealed Leslie Diaz, Infectious Disease Associates of the Palm Beaches, enrolled ineligible study subjects, failed to properly evaluate adverse events, failed to properly report serious adverse events and dispensed investigational medication to patients prior to confirming that they were enrolled in a study, according to an FDA warning letter posted online.

Results of the FDA inquiry and Diaz’s affidavit raise significant concerns about the safety and welfare of study subjects and the integrity of the site’s data, the letter states.

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