IRB forms
If you want to copy, save or otherwise work with any of these files, please right-click on the link and click on "save
target as."
IRB Protocol Submission Application
For a pdf that shows what was changed click here.
FDA Determination – Biologic
FDA Determination – Device
FDA Determination – Drug
Exempt Protocol Submission Application
For a pdf that shows what was changed click here.
Request to Review Medical Records, Charts, or Databases for Research Purposes (502-A)
Modification Form
Addition of Aurora Facility Form
Application for Continuing Review/Final Report
Suggested template format for reporting adverse events to the IRB at time of continuing review
AE Reporting Template for Continuing Review
Adverse Event Report Forms
Local Unanticipated or Adverse Event Reporting Form
External Unanticipated or Adverse Event Reporting Form
Memo to Sponsors Regarding Aurora IRB's AE Reporting Policy
Event Reporting Flow Chart
Significant New Findings Reporting Form
Significant Violation Reporting Form
Investigator Conflict of Interest Statement
Delegation of authority log
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