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Forms

Current forms related to the Duke Health IRB and Human Research Protection Program (HRPP) are located here. Click on the drop-down menu below, and you can search for forms in the following categories:

  • Advertisement and Flyer Templates
  • Continuing Review Forms
  • Consent Form Templates
  • IDE Billing Notice
  • Outside Duke Key Personnel Form
  • Research Summary Instructions and Templates
  • Review Preparatory to Research (RPR) Form
  • Telephone Scripts
  • Waivers
  • Specialty Committee Review Forms
  • CRU/Departmental Checklists
  • IRB Primary Reviewer Checklists
  • IRB Reviewer Checklists
  • Principal Investigator Checklists

Final Progress Report for Closure of an IRB-Approved Study

Continuing Review Forms

Please note in iRIS this form is no longer uploaded but part of the final report.

Humanitarian Use Device Checklist

IRB Reviewer Checklists
Principal Investigator Checklists

Checklist for Use of a Humanitarian Use Device

IDE Checklist

IRB Reviewer Checklists
Principal Investigator Checklists

The IDE Checklist below should be used to determine if an IDE is needed.

The IVD Regulatory Assessment Guide should be used to help determine when an In Vitro Diagnostic Device is subject to 21 CFR 812, the FDA's IDE regulations.

IND Checklist

IRB Reviewer Checklists
Principal Investigator Checklists

Checklist to determine if an IND is needed.

IRB Primary Reviewer Checklist - Continuing Review

IRB Primary Reviewer Checklists

Please note in iRIS this checklist is no longer uploaded but found within iRIS when you log in and navigate to your assigned protocol.

IRB Primary Reviewer Checklist - UPIRTSO

IRB Primary Reviewer Checklists

Please note in iRIS this checklist is no longer uploaded but found within iRIS when you log in and navigate to your assigned protocol.

Maestro Phone Script

Telephone Scripts

This form is a suggested format for telephone scripts to enable scheduling of research activities in Maestro Care prior to obtaining written consent.

MO345 Template-Adults

Consent Form Templates

This is a special template that is required for use with iRIS.

MO345 Template-Minors

Consent Form Templates

This is a special template that is required for use with iRIS.

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