Forms

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Frequent Caller Questions

New Studies

Name Version Date Fillable Word Adobe PDF
Request for Waiver/Alteration of HIPAA Authorization 04/02/2014 Word
Guidance on Completion of Request for Waiver/Alteration of HIPAA Authorization 05/15/2013 PDF
2014 CGIRB Meeting Schedule 01/01/2014 PDF
CGIRB Compliance Statement (currently effective through 07/20/2015) 05/15/2012 PDF
Study Application Form 02/18/2014 Word
Study Application Addendum (for Canadian submissions only) 02/18/2014 Word
CGIRB Indemnification Agreement 02/18/2014 Word
Submission Guidelines for Study Start Up 02/18/2014 PDF
Submission Letter for CGIRB Review 02/18/2014 Word
Investigator Site Questionnaire 02/18/2014 Word
Investigator Site Questionnaire for Additional Sites 02/18/2014 Word
Investigator Site Questionnaire for Post-approval Registry/Observational Studies 02/18/2014 Word
Investigator Site Questionnaire for Social/Behavioral/Educational Studies 02/18/2014 Word
Conflict of Interest Disclosure Form for Investigative Sites 02/18/2014 Word
CGIRB Investigator Guidebook 02/18/2014 PDF
Informed Consent Form and HIPAA Authorization Template 02/18/2014 Word
Short Form Subject Information and Consent Form Template 02/18/2014 Word
Children’s Assent FAQ 09/13/2011 PDF
Children’s Assent 02/18/2014 Word
Transfer of IRB Obligations Form 02/18/2014 Word
IRB Authorization Agreement 02/18/2014 Word

Studies in Progress

Name Version Date Fillable Word Adobe PDF
Submission Letter for CGIRB Review 02/18/2014 Word
Conflict of Interest Disclosure Form for Investigative Sites 02/18/2014 Word
Site-specific Change Request Form 02/18/2014 Word
Principal Investigator Transfer Form 02/18/2014 Word
Transfer Study Subject Form 02/18/2014 Word
Unanticipated Problem (UP) Submission Form (for Protocol Deviations, Violations, AEs, SAEs and all other reportable UPs) 02/18/2014 Word
IND Submission Form (for UPs that are INDs [eg, SUSARs, CIOMs, MedWatch]) 02/18/2014 Word
Instructions for Completing UP Submission Form 02/18/2014 PDF
Instructions for Completing IND Submission Form 02/18/2014 PDF

Continuing and Final Review

Name Version Date Fillable Word Adobe PDF
Continuing Review Status Report 02/18/2014 Word
Principal Investigator Site Closeout Report 02/18/2014 Word
Continuing Review Study Contact Questionnaire 02/18/2014 Word
Belmont Report 04/18/1979 PDF