Forms & Downloads

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

IRB Forms & Downloads

  • Minor Deviation Log
  • Supplement for Multi-Center Research Projects
    For Multi-Center Research Projects — BRANY IRB requires a representative of the Study Sponsor, the Lead Investigator, or the Master File site PI for a multi-site study to provide a brief summary of study-wide progress and findings, including study-wide subject accrual data, adverse event data, unanticipated problem reports, safety updates, recent literature, and any other interim findings or available study-wide progress information. This information is intended to assist the IRB in evaluating how the site-specific data and progress reported by local PIs with continuing review applications compare to the study-wide data and progress.

BRANY IRB does not require submission of external (off-site) adverse event reports unless they meet the criteria for an Unanticipated Problem.