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Forms, Templates, and Tips

This page contains forms currently required by eIRB.  For the full listing of IRB forms, go to the IRB Forms Page on the Office of Research Website.

Consent Forms

01- WFUHS Adult Informed Consent Template
Last Modified:  4/15/2021 4:04 PM
 
02-WFUHS Information Sheet Template
Last Modified:  9/2/2020 7:03 AM
 
03-Advarra Template langauge
Last Modified:  2/22/2019 12:46 PM
 
04-WFUHS Parental Permission Template
Last Modified:  6/28/2019 10:12 AM
 
05-WFUHS Short Form Consent Template
Last Modified:  2/22/2019 1:06 PM
 
06-Tips on Informed Consent Forms
Last Modified:  2/22/2019 1:06 PM
 
07-Spanish Adult Informed Consent Template
Last Modified:  2/22/2019 1:06 PM
 
08-Spanish Parental Permission Template
Last Modified:  2/22/2019 1:07 PM
 
09-External - Central IRB's Mandatory Language Document for Wake Forest .Approved v.23APR2019.pdf
Last Modified:  5/9/2019 9:16 AM
 

Assent Forms

01-Wake Forest Assent Template Age 7-10
Created Date:  2/22/2019 12:57 PM
 
02-Wake Forest Assent Template Age 11-15
Created Date:  2/22/2019 12:58 PM
 
03-Wake Forest Assent Template Age 16-17
Created Date:  2/22/2019 12:59 PM
 
04-Spanish Assent Template Age 7-10
Created Date:  2/22/2019 1:03 PM
 
05-Spanish Assent Template Age 11-15
Created Date:  2/22/2019 1:03 PM
 
06-Spanish Assent Template Age 16-17
Created Date:  2/22/2019 1:04 PM
 

Protocol & Biosketch

01 - WFUHS General Protocol Example.doc
Last Modified:  9/24/2014 3:00 PM
 
Biosketch good through 2/28/2023
Last Modified:  8/27/2020 5:04 PM
 
CV-Template2019.docx
Last Modified:  9/20/2018 11:30 AM
 

Monitoring and Oversight Checklists

EligiblilityChecklist.docx
Last Modified:  12/4/2020 11:31 AM
 
FDA Audit Checklist
Last Modified:  2/3/2011 8:34 AM
 
Informed Consent Checklist
Last Modified:  4/3/2018 10:40 AM
 
MajorProtocolDeviationDefined.docx
Last Modified:  12/4/2020 11:33 AM
 
Regulatory Binder Checklist
Last Modified:  4/4/2018 8:43 AM
 
Subject Eligibility Checklist
Last Modified:  2/3/2011 8:33 AM
 

Monitoring and Oversight Log Templates

DeviationReportForm.06NOV2018.docx
Last Modified:  11/13/2018 11:07 AM
 
Device Accountability Log
Last Modified:  4/3/2018 9:56 AM
 
Drug Accountability Log
Last Modified:  4/3/2018 9:56 AM
 
Monitoring Log
Last Modified:  4/4/2018 8:41 AM
 
Protocol Deviation Tracking
Last Modified:  4/3/2018 10:02 AM
 
Retained Body Fluids/Tissue Sample Log
Last Modified:  4/3/2018 9:58 AM
 
Screening Log
Last Modified:  4/3/2018 10:03 AM
 
Serious Adverse Event Tracking Log
Last Modified:  4/3/2018 10:04 AM
 
Site Signature and Responsibility Log
Last Modified:  4/3/2018 9:58 AM
 
Site Training Log
Last Modified:  4/4/2018 8:42 AM
 
Subject Enrollment Log
Last Modified:  4/3/2018 9:58 AM
 
Subject Identification Log
Last Modified:  4/4/2018 8:41 AM
 

Other Templates & Forms

Contents of a subject binder
Last Modified:  4/4/2018 8:46 AM
 
Contents of the regulatory file
Last Modified:  4/4/2018 8:46 AM
 
Data Use Agreement for Limited Data Sets
Last Modified:  8/19/2013 2:29 PM
 
FDA MedWatch (FDA 3500) Voluntary Reporting
Last Modified:  2/6/2019 3:54 PM
 
MajorProtocolDeviationDefined.docx
Last Modified:  12/4/2020 11:36 AM
 
Medical Records Confidentiality Agreement.pdf
Last Modified:  8/19/2013 2:27 PM
 
Vulnerable population definitions
Last Modified:  2/6/2019 3:51 PM
 
WFUHS FDA Documentation Form
Last Modified:  3/13/2014 9:57 AM
 
WFUHS Protocol Re-activation Form.docx
Last Modified:  6/1/2010 8:40 AM
 

Web Page Links

FDA Form 1572 
Last Modified:  1/17/2008 11:05 AM  
      

Radiation Safety

Radiation Safety TEDE Calculator
Save this document to your computer or network drive before completing. When complete, attach it to the Application where indicated.
Last Modified:  6/27/2007 3:15 PM
 

Memos

Short Forms

Short Form - Arabic
Last Modified:  3/10/2020 10:10 AM
 
Short Form - English
Last Modified:  3/10/2020 10:10 AM
 
Short Form - French
Last Modified:  3/10/2020 10:10 AM
 
Short Form - Russian
Last Modified:  3/10/2020 10:10 AM
 
Short Form - Spanish
Last Modified:  3/10/2020 10:10 AM
 
Short Form -Vietnamese
Last Modified:  3/10/2020 10:11 AM
 

IRB Member Tools & Documents

For use by IRB members during the review process.