Examples


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Examples A serious adverse event can be any situation that is unanticipated within a research protocol and meets the definitions included in the FDA web site, see the Federal Regulations link above. Examples include: A life threatening or persistent disability Hospitalization, or prolonging an existing hospitalization Death of the research subject Unexpected or life threatening adverse drug experience Congenital anomaly or birth defect Questions to ask when an event occurs: Does the event meet one of the above criteria for serious? Was the event probably or definitely caused by the research? Is the event beyond the scope of the risk information described in the Investigator Brochure, investigational plan, or informed consent? In other words, is the event unanticipated? If the answer to all of these questions is yes, the IRB should be notified by completing the proper form and submitting it to the IRB within 10 business days. The IRB staff is always available to consult with you regarding the serious adverse event process. Let's test your knowledge! <<< Back