What is the policy on reporting Unanticipated Problems/Adverse Events?
Investigators must report all unanticipated problems/adverse events in accordance with the submission guidelines below utilizing the Reportable Events Submission Form: Internal anticipated events will be reported in summary to the IRB at the next Continuing Review. If the investigator determines that the adverse event represents an unanticipated problem, the investigator must report it to the IRB Office within 24 hours of occurrence. The investigator must also ensure that the adverse event is reported to the sponsor or DSMB as required by protocol. External anticipated events will be reported in summary to the IRB at the next continuing review. Death or life-threatening unanticipated events must be reported to the IRB office within 5 business days. Other serious unanticipated events must be reported to the IRB office within 5 business days.
