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Forms/Instructions/Guidelines/
Other Materials
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Last Updated
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Description/Comments
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Application forms
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Application for HUD Review
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March 2004
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Request for approval of a Humanitarian Use Device protocol
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Application for New Protocol Review
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August 2012
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Application for full, expedited and exempt protocol submissions
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Consent forms
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Consent Form Template and Guidelines
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August 2012
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Consent form template, guidelines and requirements
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Consenting Tips
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December 2006
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AHC IRB consenting help sheet
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HIPAA forms, instructions & guidelines
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HIPAA Authorization
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April 2003
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Advocate HIPAA Authorization form for research
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HIPAA Authorization, Arabic
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HIPAA Authorization translation into Arabic
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HIPAA Authorization, Polish
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HIPAA Authorization translation into Polish
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HIPAA Authorization, Russian
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HIPAA Authorization translation into Russian
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HIPAA Authorization, Spanish
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HIPAA Authorization translation into Spanish
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HIPAA Waiver
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Advocate HIPAA Waiver request form for research
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HIPAA Waiver Instructions
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October 2006
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Information Sheet HIPAA Waiver instructions
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Other forms
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Adverse Event Report
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June 2005
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All local and non-local adverse events on active protocols have to be submitted with this completed form
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Amendment Report
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November 2012
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All amendments to active protocols, consents, and other protocol-related documents have to be submitted with this completed form
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Continuing Review Report
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December 2012
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Continuing review should be submitted at least 6 weeks before the study approval expiration date
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| Financial Disclosure Form |
December 2012
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This is the attestation page required in Continuing Review Reports for each investigator
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Study Closure Report
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December 2012
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Due upon study completion or 6 weeks before study approval expiration date, whichever is earlier
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Deviation/Violation Report
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June 2002
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All deviation/violations on active protocols have to be submitted with the completed form
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AHC IRB policies & guidelines
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| Advocate IRB Amendment guide |
March
2013
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Advocate Health Care IRB Amendment Submission Guidelines
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| Advocate IRB E-file procedures |
December 2011
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Advocate Health Care IRB E-file Submission Procedures
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Advocate IRB Amd form example
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June
2002
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Advocate Health Care IRB Amendment Form Example
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Advertising & Recruiting Research Subjects
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October 2006
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Information Sheeet on OHRP and FDA policy and guidelines on advertising and recruiting study subjects
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Application & Protocol Status Terminology
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October 2006
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Information Sheet on the AHC IRB application and protocol status terminology
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HIPAA & PHI Overview
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October 2006
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Information Sheet on federal HIPAA and PHI requirements
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PI Change Requirements
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February 2013
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Advocate IRB Requirements for Change of Principal Investigator
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Policies & Procedures
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June 2001
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AHC IRB Policies & Procedures (74 pages)
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QA/QI & Research
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October 2006
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Information Sheet on determining whether a project is human subject research or a Quality Assurance (QA), or Quality Improvement (QI) activity
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Term "Experiment(al)" in Human Subject Research
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October 2006
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Information Sheet on avoiding the use of the term "experiment(al)" in human subject research
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Other documents
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IRB News Letter
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April 2012
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IRB News Letter- April 2012
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Advocate IRB 2013 Schedule
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September 2012
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Advocate IRB 2013 Meeting Schedule and submission deadlines |
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Advocate IRB 2012 Schedule
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December
2011
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Advocate IRB 2012 Meeting Schedule |
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Advocate IRB Brochure
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October 2006
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Summary information on the AHC IRB
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NCI Central IRB Process
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October 2003
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NCI Central IRB initiative and process
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