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Forms & Templates
In This Section
Overview
Federalwide Assurance
Forms & Templates
Investigator Certification
Policies & Procedures
Related Links
Research HIPAA
Staff Information
Frequently Asked Questions
HIPAA Update
HIPAA Authorization templates and waivers have moved to the
Research HIPAA
page
Contact Information
IRB Administration Office
[University Hospitals]
Lakeside 1400
11100 Euclid Avenue
Cleveland, OH 44106
MS: LKS 7061
(216) 844-1529
FAX: 216-844-1547
Forms & Templates
Checklists (required as the first page of all submissions to the IRB)
New Protocol (N)
:: Feb 2008
New Protocol Chart Review or Disc Tissue (N-C or /DT)
:: May 2007
Continuing Review (CR)
:: May 2007
Continuing Review Chart Review or Disc Tissue (CR-C or DT)
:: August 2005
Exemption Determination Form
:: May 2007
Emergency Use of Drug or Device (EMRG)
:: May 2007
Protocol Addendum (A)
:: August 2005
Information to File with Protocol (F)
:: August 2005
Report Unanticipated Problem or Protocol Deviation (UD)
:: July 2007
Report External Adverse Events (EAE)
:: July-2007
Report Internal Adverse Events (IAE)
:: July-2007
Closure of an IRB Approved Protocol (C)
: May 2007 (Note: replaces
Protocol Termination (T)
)
Forms (completed to provide additional information as part of a submission to the IRB)
Request for Expedited Review of New Protocol
:: October 2002
Additional Required Information for a Study that Includes Prisoners
:: Augsut 2004
External AE Summary Log
:: July 2005
Internal AE Summary Log
:: July 2005
Request for Exemption
:: May 2007
Activity Determination Form
(DET)
Templates for Consent Documents (contain required and suggested language to use in developing consent forms)
Assent Language
:: March 2008
Consent Language for International Studies
:: April 2007
Consent Language
:: October 2007
Consent Language and Tutorial
:: October 2007
Reminder Lists (lists to help users determine if IRB submissions are complete)
New Protocol
:: August 2005
Continuing Review
:: August 2005
Addendum
:: August 2005
Chart Review/Discarded Tissue Reminders
Adverse Event Reporting Forms and Information
Adverse Event Reporting Flowchart
:: July 2007
Adverse Event Reporting Policy Summary
:: July 2007
External Adverse Event Summary Log
:: June 2005
Internal Adverse Event Summary Log
:: July 2005