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All Forms

New Studies

Name Version Date Fillable Word Adobe PDF
Submission Guidelines for Study Start Up 04/10/2015 PDF
Submission Letter for CGIRB Review 01/30/2015 Word
Study Application Form 11/07/2014 Word
Study Application Addendum for Canadian Review with CGIRB and WIRB 01/30/2015 Word
Investigator Site Questionnaire 04/21/2015 Word
Investigator Site Questionnaire for Additional Sites 06/30/2014 Word
Investigator Site Questionnaire for Social/Behavioral/Educational Studies 07/15/2014 Word
Investigator Site Questionnaire for Post-approval Registry/Observational Studies 06/30/2014 Word
IRB Authorization Agreement 04/10/2015 Word
Transfer of IRB Obligations Form 04/10/2015 Word
Conflict of Interest Disclosure Form for Investigative Sites 08/05/2014 Word
CGIRB Indemnification Agreement 02/18/2014 Word
Request for Waiver/Alteration of HIPAA Authorization 04/10/2015 Word
Guidance on Completion of Request for Waiver/Alteration of HIPAA Authorization 05/15/2013 PDF
Informed Consent Form and HIPAA Authorization Template 08/04/2014 Word
Short Form Subject Information and Consent Form Template 04/10/2015 Word
Children’s Assent FAQ 09/13/2011 PDF
Children’s Assent 06/30/2014 Word

Studies in Progress

Name Version Date Fillable Word Adobe PDF
Submission Letter for CGIRB Review 01/30/2015 Word
Conflict of Interest Disclosure Form for Investigative Sites 08/05/2014 Word
Change Request Form 11/07/2014 Word
Principal Investigator Transfer Form 01/30/2015 Word
Transfer Study Subject Form 07/15/2014 Word
Promptly Reportable Information Submission 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 Study Contact Questionnaire 02/27/2015 Word
Continuing Review Status Report 01/30/2015 Word
Principal Investigator Site Closeout Report 07/15/2014 Word

Resources

Name Version Date Fillable Word Adobe PDF
2015 CGIRB Meeting Schedule PDF
CGIRB Investigator Guidebook 02/27/2015 PDF
Investigator: Sample SOPs 02/27/2015 PDF
Nuremburg Code PDF
Belmont Report 04/18/1979 PDF
Declaration of Helsinki PDF

New Studies

Name Version Date Fillable Word Adobe PDF
Submission Guidelines for Study Start Up 04/10/2015 PDF
Submission Letter for CGIRB Review 01/30/2015 Word
Study Application Form 11/07/2014 Word
Study Application Addendum for Canadian Review with CGIRB and WIRB 01/30/2015 Word
Investigator Site Questionnaire 04/21/2015 Word
Investigator Site Questionnaire for Additional Sites 06/30/2014 Word
Investigator Site Questionnaire for Social/Behavioral/Educational Studies 07/15/2014 Word
Investigator Site Questionnaire for Post-approval Registry/Observational Studies 06/30/2014 Word
IRB Authorization Agreement 04/10/2015 Word
Transfer of IRB Obligations Form 04/10/2015 Word
Conflict of Interest Disclosure Form for Investigative Sites 08/05/2014 Word
CGIRB Indemnification Agreement 02/18/2014 Word
Request for Waiver/Alteration of HIPAA Authorization 04/10/2015 Word
Guidance on Completion of Request for Waiver/Alteration of HIPAA Authorization 05/15/2013 PDF
Informed Consent Form and HIPAA Authorization Template 08/04/2014 Word
Short Form Subject Information and Consent Form Template 04/10/2015 Word
Children’s Assent FAQ 09/13/2011 PDF
Children’s Assent 06/30/2014 Word

Studies in Progress

Name Version Date Fillable Word Adobe PDF
Submission Letter for CGIRB Review 01/30/2015 Word
Conflict of Interest Disclosure Form for Investigative Sites 08/05/2014 Word
Change Request Form 11/07/2014 Word
Principal Investigator Transfer Form 01/30/2015 Word
Transfer Study Subject Form 07/15/2014 Word
Promptly Reportable Information Submission 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 Study Contact Questionnaire 02/27/2015 Word
Continuing Review Status Report 01/30/2015 Word
Principal Investigator Site Closeout Report 07/15/2014 Word

Resources

Name Version Date Fillable Word Adobe PDF
2015 CGIRB Meeting Schedule PDF
CGIRB Investigator Guidebook 02/27/2015 PDF
Investigator: Sample SOPs 02/27/2015 PDF
Nuremburg Code PDF
Belmont Report 04/18/1979 PDF
Declaration of Helsinki PDF