Forms & Templates

Checklists/Forms

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).

Please reference the following table to identify the appropriate forms you should use when submitting to the IRB. Your IRB number will dictate which forms to use.

Use these paper forms when submitting to the IRB Use these iRIS™ forms when submitting to the IRB
(Use these forms ONLY IF your study is not already in iRIS™) Once your protocol has been approved by the IRB, you will submit all forms for this study via iRIS.
Continuing Review (CR) :: May 2007
Continuing Review Chart Review or Disc Tissue (CR-C or DT):: August 2005
UH IRB Continuing Review Form
Protocol Addendum (A) :: August 2005 UH IRB Addendum
Information to File with Protocol (F) :: August 2005 UH IRB Information to File
Report Unanticipated Problem or Protocol Deviation (UD) :: July 2007 UH IRB Unanticipated Problem or Protocol Deviation
Report External Adverse Events (EAE) :: July 2007
Report Internal Adverse Events (IAE) :: July 2007
UH IRB Adverse Event Reporting Form
Closure of an IRB Approved Protocol (C) :: May 2007 (Note: replaces Protocol Termination (T) ) UH IRB Closure

How to Locate iRIS™ Forms

  1. From your iRIS homepage, access your studies by selecting the “My Studies” link.
  2. Find the approved study that you wish to submit a form for and select “Open”.
  3. This will take you to the “Submissions” screen for that particular study.
  4. In the middle of the screen, there is a list of “Submission Forms” which you can select and fill out for this study.

(Refer to the University Hospitals Case Medical Center IRB - iRIS User Manual - Part 5 - Amendments, Continuing Reviews, etc for details instructions. To access all iRIS User Manuals, please log in to iRIS and select the Help link found in the upper right corner of any screen.)

Supplemental Forms

(Completed to provide additional information as part of a submission to the IRB)

Templates for Consent Documents

(Provide required and suggested language to use in developing consent forms)

Assent Language :: November 2012
This template contains suggested text for creating an assent form for children 7 to 13 years old.

Consent Template :: November 2012
The UH IRB Consent Template document contains headers denoting the basic required elements of informed consent. These elements are required to be contained in all consent documents. Please note, based on the nature of your study additional elements may be required. Please refer to the UH IRB Consent Language and Tutorial document for additional information.

Consent Language and Tutorial :: November 2012
The UH IRB Consent Language and Tutorial document contains template language for the numerous required sections or sections that may be required in your consent form. If you are new to writing informed consent documents it is recommended you begin the process by reviewing this tutorial.

Adverse Event Reporting Forms and Information

Please reference the following table to identify the appropriate forms you should use when submitting to the IRB. Your IRB number will dictate which forms to use.

If your IRB Number looks like this: Use these documents/logs as a guide when submitting to the IRB
xx-xx-xx

Example: 03-01-10

Note: The number should NOT have the letter C at the end.
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
CCxxxxx

Example: CC000017

Note: ‘CC’ will be found at the beginning of the number

or

xx-xx-xxC

Example: 11-11-05C

Note: ONLY the letter C will be found at the end of this number.
Minor Protocol Deviation Log :: May 2008

Adverse Event & Unanticipated Problem Log :: Sept 2010

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