Forms

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Frequent Caller Questions

New Studies

Name Version Date Fillable Word Adobe PDF
Study Applicaton Addendum for Single Review with CGIRB and WIRB (SRS Addendum) 07/19/2014 Word
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 09/02/2014 Word
Study Application Addendum (for Canadian submissions only) 08/26/2014 Word
CGIRB Indemnification Agreement 02/18/2014 Word
Submission Guidelines for Study Start Up 02/18/2014 PDF
Submission Letter for CGIRB Review 07/15/2014 Word
Investigator Site Questionnaire 07/15/2014 Word
Investigator Site Questionnaire for Additional Sites 06/30/2014 Word
Investigator Site Questionnaire for Post-approval Registry/Observational Studies 06/30/2014 Word
Investigator Site Questionnaire for Social/Behavioral/Educational Studies 07/15/2014 Word
Conflict of Interest Disclosure Form for Investigative Sites 08/05/2014 Word
CGIRB Investigator Guidebook 09/02/2014 PDF
Informed Consent Form and HIPAA Authorization Template 08/04/2014 Word
Short Form Subject Information and Consent Form Template 02/18/2014 Word
Children’s Assent FAQ 09/13/2011 PDF
Children’s Assent 06/30/2014 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
Promptly Reportable Information Submission Form 06/30/2014 Word
Submission Letter for CGIRB Review 07/15/2014 Word
Conflict of Interest Disclosure Form for Investigative Sites 08/05/2014 Word
Site-specific Change Request Form 02/18/2014 Word
Principal Investigator Transfer Form 07/15/2014 Word
Transfer Study Subject Form 07/15/2014 Word
Unanticipated Problem Report Form – The Unanticipated Problem Report form was retired on 06/30/2014. The Promptly Reportable Information Form replaces the Unanticipated Problem Report Form. 06/30/2014 Word
IND Safety Reports – Use the Promptly Reportable Information Submission Form to report SUSARs or IND safety reports that qualify as unanticipated problems. 06/30/2014 Word

Continuing and Final Review

Name Version Date Fillable Word Adobe PDF
Continuing Review Status Report 02/18/2014 Word
Principal Investigator Site Closeout Report 07/15/2014 Word
Continuing Review Study Contact Questionnaire 02/18/2014 Word
Belmont Report 04/18/1979 PDF