An IRB/IEC: 1  Reviews all study-related materials before and during the trial. 2  Must operate in accordance with national and/or local regulations, as well as with ICH good clinical practices (GCPs) guidelines.
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VAERS Information What is VAERS? The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program administered by the FDA and the CDC. VAERS collects and analyzes information about adverse events that occur after the administration of U.S. licensed vaccines.