Event Type Deadline from when the Comments investigator first learns of an (*= Requires Full Board internal event for reporting Review or SAE Subcommittee to IRB for an internal event Review) (e.g., those that occurred with within the DMC IRB’s See definitions in IRB jurisdiction) guidance documents for a description of each event. *Government inspection (or Report findings within 24 The study team should alert audit) hours, if any serious or the IRB when the inspection is continuing non-compliance scheduled or if an inspector was found or proposed; arrives unannounced, so the otherwise within 5 days. IRB may help as needed. *Privacy Violation (or Immediately report this to IRB and Privacy Officer Breach). Immediately report this to IRB *Information (Data) Security and Data Security Officer Violation (or Breach). Incarceration of a research Immediately, if participant is participant. actively incarcerated; otherwise within 5 days Any FDA Actions or changes Immediate to a HUD. Serious Adverse Event. 24 hours, if an internal AE in a The is not term “alarming” Clinical Trial meets the defined by the FDA, so it is up An AE or SAE may also meet following criteria: to the or PI’s Sponsor’s the definition of an UPIRPO, discretion on how to interpret UAE, or UADE, as described serious (or alarming) this term. below. AND An individual AE occurrence unanticipated ordinarily does not meet
Event Type (*= Requires Full Board Review or SAE Subcommittee Review) See definitions in IRB guidance documents for a description of each event. Deadline from when the investigator first learns of an internal event for reporting to IRB for an internal event (e.g., those that occurred with within the DMC IRB’s jurisdiction) Comments *Government inspection (or audit) Report findings within 24 hours, if any serious or continuing non-compliance was found or proposed; otherwise within 5 days. The study team should alert the IRB when the inspection is scheduled or if an inspector arrives unannounced, so the IRB may help as needed. *Privacy Violation (or Breach). Immediately report this to IRB and Privacy Officer *Information (Data) Security Violation (or Breach). Immediately report this to IRB and Data Security Officer Incarceration of a research participant. Immediately, if participant is actively incarcerated; otherwise within 5 days Any FDA Actions or changes to a HUD. Immediate Serious Adverse Event. An AE or SAE may also meet the definition of an UPIRPO, UAE, or UADE, as described below. 24 hours, if an internal AE in a Clinical Trial meets the following criteria: serious (or alarming) AND unanticipated The term “alarming” is not defined by the FDA, so it is up to the PI’s or Sponsor’s discretion on how to interpret this term. An individual AE occurrence ordinarily does not meet
GuidanceReportableEvents03.30.2017_000.docx