Forms & Templates


New Protocol Submission review requests, including Human Research Determinations, Exemptions, HUDs and Emergency Use requests must be submitted for review in the iRIS system (

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 iRIS™ forms when submitting to the IRB
Once your protocol has been approved by the IRB, you will submit all forms for this study via iRIS.
UH IRB Continuing Review Form
UH IRB Addendum
UH IRB Information to File
UH IRB Unanticipated Problem or Protocol Deviation
UH IRB Adverse Event Reporting Form
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 Cleveland 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.)


“Becoming a Research Volunteer” Brochure: This brochure, created by the Office of Human Research Protection (OHRP), explains what research is. It is recommended that this brochure is given to potential participants.

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)

Alternative Wording Suggestions for Consent Documents

Assent Language :: September 2016
This template contains suggested text for creating an assent form for children 7 to 13 years old.

Cancer Consent Template and Tutorial :: September 2016
Informed Consent Template and Tutorial :: January 2018
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

Example: 03-01-10

Note: The number should NOT have the letter C at the end.
Internal Adverse Event Reporting Flowchart :: Updated July 2017

External Adverse Event Reporting Flowchart :: July 2017

External Adverse Event Summary Log :: June 2005

Internal Adverse Event Summary Log :: July 2005

Example: CC000017

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



Example: 11-11-05C

Note: ONLY the letter C will be found at the end of this number.
Adverse Event & Unanticipated Problem Log :: Sept 2010

Make an Appointment

Schedule your appointment with a specialist at University Hospitals.
1-866-UH4-CARE (1-866-844-2273)

More Scheduling Options

Need to Refer a Patient?

Click here for Patient Referrals

Browse Services A-Z

Maps and Directions

Click here for directions