VPR-CLS/BRANY Central IRB
Reporting Timelines
UPIRTSOS (Unanticipated Problems) | Report per occurrence within 5 days |
Serious Adverse Events (Local) | Report per occurrence within 5 days |
Unanticipated Adverse Device Events (UADEs) | Report per occurrence within 10 days |
Complaints | Report per occurrence within 5 days |
Major Deviations | Report per occurrence within 10 days |
Minor Deviations | Report in aggregate with continuing review or study closure |