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.

Tool	Description
A-Z Index	This page has been developed as a central hub for the IRB website. It includes links to several guidance topics that may be applicable to your study.
Ancillary Committee Pathway Map [PDF]	This flowchart shows the order an application will take through ancillary committee reviews once it is submitted in ERICA.
Audit Checklists	This page includes copies of the checklists the IRB uses when auditing studies.
Consent Process Models	This page includes examples of different consent processes the IRB suggests for common study designs.
Editing Contact Persons in ERICA	This page includes instructions for creating an account in ERICA, and getting a uNID and password for ERICA
ERICA Access Instructions	This page includes instructions for creating an account in ERICA, and getting a uNID and password for ERICA.
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.
Frequently-Asked Questions	Answers to your most frequently asked questions can be found here. Content is updated as needed, so check this page often.
Glossary	This will link you to definitions of commonly-used IRB terms and abbreviations.
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.
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.
IRB Process Flowcharts	This page includes flowcharts showing the complete IRB process from submission to final processing.
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.
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.
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.
Self-Assessments	This page includes copies of the self-assessments the IRB periodically sends to study teams.
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.
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.
Troubleshooting Error Messages in ERICA	Commonly reported error messages and their resolutions are explained on this page
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.

Tool

Description

A-Z Index

This page has been developed as a central hub for the IRB website. It includes links to several guidance topics that may be applicable to your study.

Ancillary Committee Pathway Map [PDF]

This flowchart shows the order an application will take through ancillary committee reviews once it is submitted in ERICA.

Audit Checklists

This page includes copies of the checklists the IRB uses when auditing studies.

Consent Process Models

This page includes examples of different consent processes the IRB suggests for common study designs.

Editing Contact Persons in ERICA

This page includes instructions for creating an account in ERICA, and getting a uNID and password for ERICA

ERICA Access Instructions

This page includes instructions for creating an account in ERICA, and getting a uNID and password for ERICA.

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.

Frequently-Asked Questions

Answers to your most frequently asked questions can be found here. Content is updated as needed, so check this page often.

Glossary

This will link you to definitions of commonly-used IRB terms and abbreviations.

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.

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.

IRB Process Flowcharts

This page includes flowcharts showing the complete IRB process from submission to final processing.

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.

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.

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.

Self-Assessments

This page includes copies of the self-assessments the IRB periodically sends to study teams.

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.

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.

Troubleshooting Error Messages in ERICA

Commonly reported error messages and their resolutions are explained on this page

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.