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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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SAEs and IND Safety Reports

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  1. SAEs and IND Safety Reports When to report to the IRB

  2. 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 Report to IRB at continuing Review Is the event Internal or external? Report to IRB in writing within 5 days using Report of SAE/IND Safety Report Form Report to IRB within 10 days using Report of SAE/IND Safety Report Form Is it Related, Probably related or Possibly related to the study interventions? Yes No Anticipated unanticipated No Yes Internal External for guidance see http://www.hhs.gov/ohrp/policy/advevntguid.html

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