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All Forms

Many of CGIRB’s Word-format submission forms are now retired and replaced with dynamic, PDF-based submission forms!

New pdf-based smart forms are now available below for sending initial reviews, changes in research, promptly reportable information, continuing review, and study closure information.

Please note the following about our improved forms:

  • The SMART Forms must be completed using either Adobe’s free Reader or Adobe Acrobat (version 9.1 or newer). Use of a program other than Adobe (version 9.1 or newer) to view or complete the forms will result in missing questions and non-functional fields. To download Adobe Reader for free, please visit https://get.adobe.com/reader/. (If you do not have access to Adobe’s Reader or Acrobat, you may continue to submit the Word-format forms. In 2016 we will be making available an html5 [online] version of the forms that do not require Adobe software.)
  • Because these SMART Forms are dynamic (change based on your responses), they must be completed electronically; therefore, you cannot print them out and complete them on paper. However, at any time during their completion, you can edit, save, print, or share with your colleagues.
  • We will continue to accept the old forms until December 1, 2016.

A brief orientation and tutorial on the new forms is available here: http://www.cgirb.com/wp-content/uploads/2015/12/WCG-SMART-Forms-Training-Guide.pdf

The forms below provide CGIRB with all the required IRB review information required. Please provide a submission form with each protocol you submit for review.

For questions or assistance, please see the CGIRB Guide for Researchers available below, call 1-888-303-2224, or email irb@cgirb.com.

New Studies

Name Version Date Fillable Word Adobe PDF
Initial Review Submission Form 09/22/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Addendum for Department of Defense Funded Research Form 12/19/2016 Word
IRB Reliance Agreement Form 07/19/2016 Word
Submission Guidelines for Study Start Up 01/21/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Submission Letter for CGIRB Review 01/21/2016 Word
Investigator Site Questionnaire for In Vitro Diagnostic (IVD) Research 06/29/2015 Word
Investigator Site Questionnaire for Post-approval Registry/Observational Studies 06/29/2015 Word
Conflict of Interest Disclosure Form for Investigative Sites 01/21/2016 Word
Request for Waiver/Alteration of HIPAA Authorization 01/20/2017 Word
Guidance on Completion of Request for Waiver/Alteration of HIPAA Authorization 05/15/2013 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
WCG Indemnification Agreement (Blanket) 04/15/2015 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
WCG Indemnification Agreement (Study Specific) 04/15/2015 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Impartial Witness Form for Limited and Non-Readers 03/01/2017 Word
Informed Consent Form and HIPAA Authorization Template 01/20/2017 Word
Short Form Subject Information and Consent Form Template 04/10/2015 Word
Children’s Assent FAQ 09/13/2011 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Children’s Assent 06/30/2014 Word

Studies in Progress

Name Version Date Fillable Word Adobe PDF
Change in Research Form 08/19/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Promptly Reportable Information Submission Form (Please submit via Connexus, or via email at: up@cgirb.com). Use the Promptly Reportable Information Submission Form to report SUSARs or IND safety reports that qualify as unanticipated problems. 08/19/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
NOTICE: Change in acknowledgment process for Promptly Reportable Information submissions 01/15/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Translation Request Form 05/16/2016 Word
Submission Letter for CGIRB Review 01/21/2016 Word
Conflict of Interest Disclosure Form for Investigative Sites 01/21/2016 Word
Principal Investigator Transfer Form 01/21/2016 Word

Continuing and Final Review

Name Version Date Fillable Word Adobe PDF
Site Continuing Review Report 09/22/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Closure Report (To be completed when the PI site is ready to close out IRB approval for the study) 09/22/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Continuing Review Report – Study (To be completed by Sponsor or CRO) 09/22/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form

Resources

Name Version Date Fillable Word Adobe PDF
2017 CGIRB Meeting Schedule 01/01/2017 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
California Experimental Research Subject’s Bill of Rights – English Word
California Experimental Research Subject’s Bill of Rights – Spanish Word
California Experimental Research Subject’s Bill of Rights – Tagalog Word
CGIRB Investigator Guidebook 04/21/2017 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Investigator Obligations and Guidance SOPs 03/01/2017 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Nuremburg Code PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Belmont Report 04/18/1979 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Declaration of Helsinki PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form

New Studies

Name Version Date Fillable Word Adobe PDF
Initial Review Submission Form 09/22/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Addendum for Department of Defense Funded Research Form 12/19/2016 Word
IRB Reliance Agreement Form 07/19/2016 Word
Submission Guidelines for Study Start Up 01/21/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Submission Letter for CGIRB Review 01/21/2016 Word
Investigator Site Questionnaire for In Vitro Diagnostic (IVD) Research 06/29/2015 Word
Investigator Site Questionnaire for Post-approval Registry/Observational Studies 06/29/2015 Word
Conflict of Interest Disclosure Form for Investigative Sites 01/21/2016 Word
Request for Waiver/Alteration of HIPAA Authorization 01/20/2017 Word
Guidance on Completion of Request for Waiver/Alteration of HIPAA Authorization 05/15/2013 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
WCG Indemnification Agreement (Blanket) 04/15/2015 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
WCG Indemnification Agreement (Study Specific) 04/15/2015 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Impartial Witness Form for Limited and Non-Readers 03/01/2017 Word
Informed Consent Form and HIPAA Authorization Template 01/20/2017 Word
Short Form Subject Information and Consent Form Template 04/10/2015 Word
Children’s Assent FAQ 09/13/2011 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Children’s Assent 06/30/2014 Word

Studies in Progress

Name Version Date Fillable Word Adobe PDF
Change in Research Form 08/19/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Promptly Reportable Information Submission Form (Please submit via Connexus, or via email at: up@cgirb.com). Use the Promptly Reportable Information Submission Form to report SUSARs or IND safety reports that qualify as unanticipated problems. 08/19/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
NOTICE: Change in acknowledgment process for Promptly Reportable Information submissions 01/15/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Translation Request Form 05/16/2016 Word
Submission Letter for CGIRB Review 01/21/2016 Word
Conflict of Interest Disclosure Form for Investigative Sites 01/21/2016 Word
Principal Investigator Transfer Form 01/21/2016 Word

Continuing and Final Review

Name Version Date Fillable Word Adobe PDF
Site Continuing Review Report 09/22/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Closure Report (To be completed when the PI site is ready to close out IRB approval for the study) 09/22/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Continuing Review Report – Study (To be completed by Sponsor or CRO) 09/22/2016 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form

Resources

Name Version Date Fillable Word Adobe PDF
2017 CGIRB Meeting Schedule 01/01/2017 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
California Experimental Research Subject’s Bill of Rights – English Word
California Experimental Research Subject’s Bill of Rights – Spanish Word
California Experimental Research Subject’s Bill of Rights – Tagalog Word
CGIRB Investigator Guidebook 04/21/2017 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Investigator Obligations and Guidance SOPs 03/01/2017 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Nuremburg Code PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Belmont Report 04/18/1979 PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form
Declaration of Helsinki PDF
Right-click the link and select ‘Save Target As’ or ‘Save Link As’ and navigate to the destination folder to open form