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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 08/20/2009 CGIRB Indemnification Agreement 01/14/2010 Submission Guidelines for Study Start Up 01/12/2010 - Submission Letter for CGIRB Review 04/15/2009 Investigator Site Questionnaire 02/11/2008 Investigator Site Questionnaire for Additional Sites 02/11/2008 Investigator Site Questionnaire for Phase IV Studies, Non-IND, and Device Studies 02/11/2008 Investigator Site Questionnaire for Post-approval Registry/Observational Studies 09/17/2009 Investigator Site Questionnaire for Social/Behavioral/Educational Studies 02/11/2008 Conflict of Interest Disclosure Form for Investigative Sites 04/28/2008 FDA 1572 (links externally to fda.gov website) - CGIRB Investigator Guidebook 04/28/2008 - 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 12/02/2008 Subject Information and Consent Form Checklist 07/22/2009 Request for Waiver/Alteration of Authorization & Guidance on Completion 05/16/2008 Transfer of IRB Obligations Form 02/11/2008 STUDIES IN PROGRESS VERSION DATE FILLABLE WORD ADOBE PDF Investigator Site Questionnaire 02/11/2008 Site-specific Change Request Form 02/11/2008 Conflict of Interest Disclosure Form for Investigative Sites 04/28/2008 FDA 1572 (links externally to fda.gov website) - Instructions for Completing Suspected Unanticipated Problem Report Form 10/16/2009 - Suspected Unanticipated Problem Report Form Please submit all reportable Safety information including but not limited to SAEs, Protocol Deviations and IND Safety Reports to one of the following: UP Email: up@cgirb.com UP Fax: 919-654-7199 10/16/2009 CONTINUING AND FINAL REVIEW VERSION DATE FILLABLE WORD ADOBE PDF Continuing Review Status Report 03/31/2008 Investigator Site Closure Request and Final Study Status Report 03/31/2008 Continuing Review Study Contact Questionnaire 04/25/2008 Continuing Review Process (HTML) - - - The Belmont Report 04/18/1979 -

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