LOCAL UNANTICIPATED SERIOUS ADVERSE EVENTS (SAEs) UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS (UPRs) SIGNIFICANT SAFETY REPORTS / DATA MONITORING COMMITTEE (DMC) REPORTS Reviewed & Reported to CATEGORIZED BY IRB* categorized Date Date IRB within Date reported within Reported to ORO UPR/SAE Learned of Subject ID Event required to IRB required time Y/N/NA U R S time period Occurred Event period Y/N Y/N Y/N Y/N/NA Y/N/NA * U Unanticipated R Related to study participation S Serious – – –
LOCAL UNANTICIPATED SERIOUS ADVERSE EVENTS (SAEs) UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS (UPRs) SIGNIFICANT SAFETY REPORTS / DATA MONITORING COMMITTEE (DMC) REPORTS Date UPR/SAE Occurred Date Learned of Event Subject ID Event Date reported to IRB Reported to IRB within required time period Y/N/NA Reviewed & categorized within required time period Y/N/NA CATEGORIZED BY IRB* Reported to ORO Y/N/NA U Y/N R Y/N S Y/N * U – Unanticipated R – Related to study participation S – Serious