Study guides, Class notes & Summaries

A sponsor who determines and unanticipated AE presents unreasonable risk, termination shall occur within _____ working days and not later than ___ working days after sponsor first received notice of effect - ANSWER-5, 15 IRB determinations for emergency situations are to be retained by IRB for at least ___ years after completion of clinical investigation - ANSWER-3 Al IRB records need to be kept for ____ years follow completion of research - ANSWER-3 FDA will provide written determinati...