IRB Forms and Templates

Checklists

(required as the first page of all submissions to the IRB)

New Protocol Submission review requests, including Human Research Determinations, Exemptions, HUDs and Emergency Use requests, must be submitted for review in the iRIS system (https://cortex.case.edu).

• Continuing Review (CR) :: May 2007
• Continuing Review Chart Review or Disc Tissue (CR-C or DT) :: August 2005
• 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)

• External AE Summary Log :: July 2005
• Internal AE Summary Log :: July 2005
• UH Administrative Form, CP-7: IDS Exception Request Form (Word version) :: May 2009

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 Template :: July 2010
• Consent Language and Tutorial :: June 2011

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