What are the requirements for reporting adverse events?
All adverse events that are BOTH unexpected and serious are reported to the IRB. Investigators must submit information to the IRB within 10 working days for any event that occurs at your site that is BOTH serious AND unexpected. An unexpected SAE is an adverse event that meets the definition of serious but does not appear as a potential risk in the protocol, clinical investigator brochure (CIB), package insert (if applicable) or the most recent informed consent document for the study. When the report is sent to the IRB, the IRB will review the unexpected SAE and determine whether additional risks to the subjects require a revision to the Subject Information and Consent Form.
All adverse events that are BOTH unexpected and serious are reported to the IRB. Investigators must submit information to the IRB within 10 working days for any event that occurs at your site that is BOTH serious AND unexpected. An unexpected SAE is an adverse event that meets the definition of serious but does not appear as a potential risk in the protocol, clinical investigator brochure (CIB), package insert (if applicable) or the most recent informed consent document for the study. When the report is sent to the IRB, the IRB will review the unexpected SAE and determine whether additional risks to the subjects require a revision to the Subject Information and Consent Form. Events which are BOTH serious AND unexpected should be faxed to the IRB using the IRB SAE Submission coversheet and attaching either the sponsor’s SAE form or the IRB SAE Form. If the SAE is reported without using the IRB SAE Submission coversheet, the investigator must note a determination of whether they determin
