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Home » FDA: Researcher Delays Reporting Patient Hospitalization to IRB
FDA: Researcher Delays Reporting Patient Hospitalization to IRB
February 20, 2009
A Florida investigator did not properly supervise three clinical trials and failed to notify the institutional review board (IRB) for two months that a subject had been hospitalized in an intensive care unit for a bilateral pulmonary embolism for a week, an FDA warning letter says.