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 SpartaIRB System (https://spartairb.case.edu).

Protocol Templates

In SpartaIRB, much of the information about your study will be submitted to the IRB in a protocol template document that is a Microsoft Word file. When submitting in SpartaIRB, the use of one of these templates is REQUIRED.

Please use these documents to prepare your study for submission to the UH IRB.
HRP-503BIO: Biomedical Protocol template
HRP-503SBER: SBER Protocol template
HRP-503DATA: Chart Review Data + Specimens Protocol template
HRP-503NHR: Non-Human or Non-Research Protocol template
HRP-503RLY: Relying Institution Protocol template
HRP-503SUPP: Supplement for Biomedical Clinical Sponsored Protocols template

Download the protocol templates from the SpartaIRB Library under the Templates tab (login required)

Recruitment

“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.

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
xx-xx-xx

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
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.
Adverse Event & Unanticipated Problem Log :: Sept 2010