Event Type Deadline from when the Comments investigator first learns of an (*= Requires Full Review internal event for reporting or SAE Subcommittee Review) to IRB for an internal event (e.g., those that occurred with See definitions in IRB within the DMC IRB’s guidance documents for a jurisdiction) 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 Breach). and Privacy Officer 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 in Clinical When reporting a death, when the AE meets all of the please include the date of An AE or SAE may also meet following criteria: death, if known. the definition of an UPIRPO, UAE, or UADE, as described serious (SAE) or Investigators are required to below. alarming, report promptly the sponsor “to unanticipated, AND any adverse effect that may definitely, probably, or reasonably be regarded as possibly related to the caused by, or probably caused investigational agent. by, the drug. If the adverse effect is alarming, the For more information, see . investigator shall report the adverse effect immediately’”. Consult with the Sponsor or FDA for additional guidance. The term is not “alarming” defined by the FDA, so it is up to the PI’s or Sponsor’s discretion on how to interpret this term.
Event Type (*= Requires Full 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 in Clinical when the AE meets all of the following criteria: serious (SAE) or alarming, unanticipated, AND definitely, probably, or possibly related to the investigational agent. For more information, see . When reporting a death, please include the date of death, if known. Investigators are required to report promptly “to the sponsor any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, the investigator shall report the adverse effect immediately’”. Consult with the Sponsor or FDA for additional guidance. 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.
IRB-01HumanResearchProtectionsProgramPolicyDRAFT03.08.2017-LOCKED.docx