LOCAL UNANTICIPATED SERIOUS ADVERSE EVENTS (SAEs) UNANTICIPATED SERIOUS PROBLEMS SIGNIFICANT SAFETY REPORTS / DATA MONITORING COMMITTEE (DMC) REPORTS Reported to Reviewed & CATEGORIZED BY IRB* Date IRB within categorized Date event Date reported Reported to ORO Learned Subject ID Event required within required Occurred to IRB Y/N/NA U R S time period time period of Event 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 SERIOUS PROBLEMS SIGNIFICANT SAFETY REPORTS / DATA MONITORING COMMITTEE (DMC) REPORTS Date event 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
2017-2018_HRPP_Audit_Tool.docx