Forms

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Frequent Caller Questions

New Studies

Name Version Date Fillable Word Adobe PDF
2012 CGIRB Meeting Schedule 01/01/2012 PDF
CGIRB Compliance Statement PDF
Study Application Form 06/07/2011 Word PDF
Study Application Addendum (for Canadian submissions only) 08/10/2011 Word PDF
CGIRB Indemnification Agreement 06/07/2011 Word PDF
Submission Guidelines for Study Start Up 01/06/2012 Word PDF
Submission Letter for CGIRB Review 01/06/2012 Word PDF
Investigator Site Questionnaire 04/18/2012 Word
Investigator Site Questionnaire for Additional Sites 04/18/2012 Word
Investigator Site Questionnaire for Post-approval Registry/Observational Studies 04/18/2012 Word
Investigator Site Questionnaire for Social/Behavioral/Educational Studies 04/18/2012 Word
Conflict of Interest Disclosure Form for Investigative Sites 03/07/2011 Word PDF
CGIRB Investigator Guidebook 02/02/2012 PDF
Checklist for HIPAA Authorization Language 10/20/2009 Word PDF
Subject Information and Consent Form and Authorization to Use and Disclose Personal Health Information for Research Template 01/07/2011 Word PDF
Short Form Subject Information and Consent Form Template 01/06/2012 Word PDF
Subject Information and Consent Form Checklist 06/07/2010 PDF
Children’s Assent FAQ 09/13/2011 PDF
Children’s Assent 09/07/2011 Word PDF
Request for Waiver/Alteration of Authorization & Guidance on Completion 03/07/2011 Word PDF
Transfer of IRB Obligations Form 03/07/2011 Word PDF
IRB Authorization Agreement 01/14/2010 Word PDF

Studies in Progress

Name Version Date Fillable Word Adobe PDF
Submission Letter for CGIRB Review 01/06/2012 Word PDF
Conflict of Interest Disclosure Form for Investigative Sites 03/07/2011 Word PDF
Site-specific Change Request Form 03/04/2011 Word PDF
Principal Investigator Transfer Form 03/07/2011 Word PDF
Transfer Study Subject Form 03/07/2011 Word PDF
Unanticipated Problem (UP) Submission Form (for Protocol Deviations, Violations, AEs, SAEs and all other reportable UPs) 03/07/2011 Word PDF
IND Submission Form (for UPs that are INDs [eg, SUSARs, CIOMs, MedWatch]) 03/07/2011 Word PDF
Instructions for Completing UP Submission Form 09/13/2010 Word PDF
Instructions for Completing IND Submission Form 03/07/2011 Word PDF

Continuing and Final Review

Name Version Date Fillable Word Adobe PDF
Continuing Review Status Report 04/04/2011 Word PDF
Principal Investigator Site Closeout Report 10/04/2011 Word PDF
Continuing Review Study Contact Questionnaire 03/07/2011 Word PDF
Belmont Report 04/18/1979 PDF