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NEW STUDY VERSION DATE FILLABLE WORD ADOBE PDF CGIRB Meeting Schedule (HTML) - - - Current CGIRB Board Membership Roster (HTML) - - - CGIRB Board Membership Roster Archive (HTML) - - - CGIRB Compliance Statement (HTML) - - - Study Information and Commitment Form 05/17/2010 CGIRB Indemnification Agreement 01/14/2010 Submission Guidelines for Study Start Up 01/12/2010 - Submission Letter for CGIRB Review 05/17/2010 Investigator Site Questionnaire 09/03/2010 Investigator Site Questionnaire for Additional Sites 09/03/2010 Investigator Site Questionnaire for Post-approval Registry/Observational Studies 09/03/2010 Investigator Site Questionnaire for Social/Behavioral/Educational Studies 09/03/2010 Conflict of Interest Disclosure Form for Investigative Sites 05/17/2010 FDA 1572 (HTML) - - - CGIRB Investigator Guidebook 05/17/2010 - Checklist for HIPAA Authorization Language 10/20/2009 Subject Information and Consent Form and Authorization to Use and Disclose Personal Health Information for Research Template 05/17/2010 Subject Information and Consent Form Checklist 05/17/2010 Request for Waiver/Alteration of Authorization & Guidance on Completion 07/02/2010 Transfer of IRB Obligations Form 07/02/2010 STUDIES IN PROGRESS VERSION DATE FILLABLE WORD ADOBE PDF Investigator Site Questionnaire 09/03/2010 Site-specific Change Request Form 07/02/2010 Conflict of Interest Disclosure Form for Investigative Sites 05/17/2010 FDA 1572 (links externally to fda.gov website) - CGIRB has two forms for reporting Unanticipated Problem (UP) events. Submit each UP event on the appropriate form. Instructions for Completing IND Submission Form 07/02/2010 IND Submission Form (for UPs that are INDs [eg, SUSARs, CIOMs, MedWatch]) 07/02/2010 Instructions for Completing UP Submission Form 07/02/2010 UP Submission Form (for AE's, deviations and all other reportable UPs) 07/02/2010 Please submit all UPs to one of the following: UP Email: up@cgirb.com UP Fax: 919-654-7199 CONTINUING AND FINAL REVIEW VERSION DATE FILLABLE WORD ADOBE PDF Continuing Review Status Report 05/21/2010 Investigator Site Closure Request and Final Study Status Report 07/02/2010 Continuing Review Study Contact Questionnaire 08/19/2010 The Belmont Report 04/18/1979 -

FORMS FOR INSTITUTIONS VERSION DATE FILLABLE WORD ADOBE PDF IRB Authorization Agreement 01/14/2010