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Study Team Toolkit


This page has been designed to help study coordinators and investigators navigate the essential parts of the IRB process smoothly. If you have suggestions for additions or enhancements for this page or any page on the IRB website, please contact the IRB at irb@hsc.utah.edu.

Audit Checklists
This page includes copies of the checklists the IRB uses when auditing studies.
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Consent Process Models
This page includes examples of different consent processes the IRB suggests for common study designs.
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Editing Contact Persons in ERICA
This page includes instructions for creating an account in ERICA, and getting a uNID and password for ERICA.
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ERICA Access Instructions
This page includes instructions for creating an account in ERICA, and getting a uNID and password for ERICA.
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ERICA Status Key
This guide includes a table with all of the ERICA process status labels and an explanation of what it means for the application when it is in that status.
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Glossary
This will link you to definitions of commonly-used IRB terms and abbreviations.
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Human Subjects Research Training
University of Utah investigators and study staff who conduct human subject research must complete an IRB approved method of human subjects research training before the IRB will approve their project. This page outlines the options available to investigators to satisfy this requirement.
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Investigator Guidance Series
This page serves as a central hub for all of the IGS documents. Topics are updated regularly; this page should be the starting point for any coordinator with a question about IRB policy on a specific topic.
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IRB Registration
This page includes the University of Utah’s IRB registration information for DHHS and FDA, including our FWA number and panel registration numbers.
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New Investigator Toolkit
So, you’ve never submitted an application to the University of Utah Institutional Review Board before? This page has been designed to walk you through the process and assist you with your first human subjects research application.
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Preparation Packet for Investigator-Initiated Drug and Device Studies
This page contains resources for investigators who are preparing to conduct an investigator-initiated study that involves an investigational drug requiring an IND, or an investigational device requiring an IDE.
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Self-Assessments
This page includes copies of the self-assessments the IRB periodically sends to study teams.
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Submission and Review Schedules
This page should give you a good estimate for review time lines you can expect when you submit to the IRB.
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Tracked Changes Tutorial
This tutorial will show you how to track your changes and attach documents that are helpful to the IRB, and will explain why tracking is so important for a smooth IRB review.
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Troubleshooting Error Messages in ERICA
Commonly reported error messages and their resolutions are explained on this page.
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Who Should I Contact for Assistance?
This page includes answers to the most frequently-asked questions the IRB receives about which staff member can help them at a given point in the IRB review process.
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