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Advevntguid html - PowerPoint PPT Presentation

SAEs and IND Safety Reports

SAEs and IND Safety Reports. When to report to the IRB. Is it Serious? (death, disability, incapacity, hospitalization (initial/prolonged), required intervention to prevent permanent impairment). Is it Unanticipated? (not listed in protocol/informed consent form). Event is an AE; not SAE

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Advevntguid html - PowerPoint PPT Presentation

SAEs and IND Safety Reports