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

HRP-506ASSENTC - TEMPLATE - CWRU Assent

HRP-506ASSENTUH - TEMPLATE - UH Assent
HRP-506BIO - TEMPLATE- UH BIO Consent Template
HRP-506CANCER - TEMPLATE - UH Cancer Informed Consent Document Template
HRP-506EU - TEMPLATE - Consent Document - Emergency Use
HRP-506SBER - TEMPLATE - CWRU Social & Behavioral Informed Consent Document Template

Download the consent and assent templates from the SpartaIRB Library under the Templates tab (login required).

Adverse Event Reporting Forms and Information

Please refer to the Investigator Manual for IRB Submissions for reporting requirements.