Fda: Researcher Delays Reporting Patient Hospitalization To Irb

摘要

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.rnTwo of the trials investigated hypertension drugs, and the third looked at Pfizer's Lipitor (atorvastatin) in combination with another drug to treat hypercholesterolemia, according to the letter, which was based on an inspection conducted in 2007.