BRANY IRB Forms and Downloads

IRB Membership List — Compliance Statement — Meeting Schedule

xForms Submissions How-to

Initial Submission or Exemption Request

Informed Consent

HIPAA Authorization (Waiver or Alteration)

Modifications to Already Approved Studies

  • Submission guidance: Modifications
  • xForm #01 – Request for IRB Review of Modifications – via IRBManager
    • Additional or relocated research site
    • Protocol Amendment
    • New or updated device or drug brochure
    • New or updated consent document
    • New or updated subject material (e.g., advertisements, diaries, ID cards, surveys)
    • Request for or submission of translated material
    • Report (e.g., Interim Analysis, DSMB, Annual Reports, Safety Updates)

Personnel Changes

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Continuing Review

  • xForm #11 – Application for Continuing Approval
    • 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

Reporting Timelines

Reporting timelines

Notification of Study Status Changes

General Information & Guidance

Not sure what form to use or how to fill it out? Please contact us