Forms & Downloads

IRB Forms & Downloads

IRB Membership List — Compliance Statement — Meeting Schedule    

Initial Submission or Exemption Request               

IRBManager Getting Started

Informed Consent

Continuing Review          

  • 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.

Reportable Events

Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSOs)

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

Notification of Study Status Changes