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Department for Human Research Protections : Biomedical IRB Submission Forms

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Department for Human Research Protections
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Biomedical IRB Submission Forms
Adverse Events Continuing Review
Summary Table

Deviation/Violation

UT Adverse Event Form

Adverse Event Policy

The UT Adverse Event policy was updated  and became effective 09/01/2008.

Convened Continuing Review Checklist       

Please complete and attach this checklist to your application.

Continuing Review Application  

This application was updated 08/01/2009

                            

 
Amendments/Modifications Exempt Review

Convened Amendment Checklist 

Please complete this checklist and attach to your application.

Change Cover Sheet
     
A. Additions/Deletions

B. Protocol Change

C. Investigators Brochure or Safety Changes

D. Changes to Consent

E. Miscellaneous Changes            

Exempt Categories & Screening Questions

Exempt Research Application

This application was updated 08/01/2009

 

Assent Information Expedited Review

Adult Assent Form

Expedited Review Checklist

Please complete this checklist and attach to your application.

Expedited Research Categories

Expedited Application

This application was updated 08/01/2009

Waiver of Authorization for Use and Disclosure of PHI 

The Waiver form was updated 08/01/2009

Chart Reviews Initial Convened Review
Chart Review Plan

Please submit a Chart Review Plan to the IRB office before completing an application.  After the plan has been reviewed, the office staff will contact you with the name of the application you should complete.

Initial Convened Review Checklist

Please complete this checklist and attach to your application.

Initial Convened Application 

This application was updated 08/01/2009

Section E-2 Drug Information Attachment

         Section E-3 Device Information Attachment

 

Compliance Forms

 

Final Reports

        RSP Conflict of Interest Disclosure

       Please complete this form for all research projects regardless of funding status.
Final Report Instructions

Final Report Form
Consent Forms

Miscellaneous Forms

Consent Instructions

Consent Template         

Addendum to Consent

Waiver of Authorization for Use and Disclosure of PHI

The Waiver form was updated 08/01/2009

Cancellation or Modification of Participation in Research

Supplemental Consent for Genetics Research


 

GRAD Approval Form

Elements of a Research Protocol

PI Responsibilities

Trade Secrets & Intellectual Property

Statement of Compliance

WIRB Forms

WIRB Pre-Review Approval Form

WIRB Approval Checklist 

External IRB Personnel Log

Page updated: November 05, 2009
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