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IRB Forms and 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.

If your IRB Number looks like this: Use these paper forms when submitting to the IRB
(Use these forms ONLY IF your study is not already in iRIS™)		 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.

xx-xx-xx

Example: 03-01-10

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

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. 		Request for Continuing Review Form :: 9-30-2010
Continuing Review Form for Retrospective Chart Reviews :: 5-26-2011

Amendment to Research Form :: 7-16-2009

Adverse Event & Unanticipated Problem Report Form :: 11-18-2010

Note to File Form :: 9-14-2006

Major Protocol Deviation Report Form :: 5-15-2008
Minor Protocol Deviation Log :: 5-15-2008

Request for Waiver or Alteration of the HIPAA Authorization Requirement :: 11-4-2008

Research Staff Log :: 7-29-2010

IRB Protocol Closure Form :: 4-23-2009 		Cancer IRB – Request for Continuing Review




Cancer IRB – Amendment to Research Form

*See below for reporting log


Cancer IRB – Note to File Form

*See below for reporting log






Cancer IRB – Performance Site and Personnel Registration Form



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 Cetner IRB - iRIS User Manual - Part 5 - Amendments, Continuing Reviews, etc for details instructions. To access all iRIS User Manuals, please login to iRIS and select the Help link found in the upper right corner of any screen.)

Forms

Supplemental Forms

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

Templates

Templates for Consent Documents

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

Assent Language :: March 2008
This template contains suggested text for creating an assent form for children 7 to 13 years old.

Consent Template :: July 2010
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 :: February 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

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