FDA: Researcher Delays Reporting Patient Hospitalization to IRB

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. When Christopher Chappel of Family Practice Associates reported the incident to the IRB, he called it a protocol deviation rather than an adverse event, according to the agency’s letter.
Washington Drug Letter