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IRB forms

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IRB Protocol Submission Application *Minor Correction*

For a PDF that shows what was changed, click here.

FDA Determination -- Biologic

FDA Determination -- Device

FDA Determination -- Drug

Exempt Protocol Submission Application

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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