See definitions in IRB guidance documents for a description of each event. *Government inspection (or Report findings within 24 If the IRB is not aware of the audit) hours, if any serious or government inspection, the continuing non-compliance study team should alert the was found or proposed; IRB when the inspection is otherwise report at the time of scheduled or if an inspector continuing review or study arrives unannounced, so the closure. 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 If an already-enrolled research participant. actively incarcerated; participant becomes otherwise within 5 days. incarcerated, all research interventions and interactions cease (except those required for the well-being of the research participant) until the IRB has made the prisoner determinations. Any FDA Actions or changes Immediate. to a HUD. Serious Adverse Event. 24 hours, if in a Clinical Trial CAUTION: If the IRB approves an internal AE meets the a protocol that has more strict An AE or SAE may also meet following criteria: SAE reporting requirements the definition of an UPIRPO, (e.g., required by the sponsor), UAE, or UADE, as described serious (or alarming) the PI must report those SAEs below. AND
See definitions in IRB guidance documents for a description of each event. *Government inspection (or audit) Report findings within 24 hours, if any serious or continuing non-compliance was found or proposed; otherwise report at the time of continuing review or study closure. If the IRB is not aware of the government inspection, 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. If an already-enrolled research participant becomes incarcerated, all research interventions and interactions cease (except those required for the well-being of the research participant) until the IRB has made the prisoner determinations. 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 a Clinical Trial an internal AE meets the following criteria: serious (or alarming) AND CAUTION: If the IRB approves a protocol that has more strict SAE reporting requirements (e.g., required by the sponsor), the PI must report those SAEs
SUNYDMCIRB-01Policy01.19.2017FINAL-LOCKED.docx