Training, System User Guides, and Guidance Sheets | Human Research Protection Program (HRPP)

📩Did we get your submission?

Check the orange highlight on your workspace flowchart to see your true status.
The orange highlight indicates where the submission is.
Clicking Finish on the form only saves your work. Your study is not sent to the IRB until you click Submit on the left-side menu of your workspace.
Refer to the applicable user guide on the IRB Training & User Guides section for step-by-step instructions on how to submit the study.

Pre-Submission
The submission is still with the study team. It has not been submitted yet. To fix: You must click the 'Submit' button on the left menu.

Pre-Review

Success! The submission has been received by the IRB.

💻System User Guides

System User Guides provide step-by step instructions for using the Research Gateway IRB (ReGI) system.
Study teams can download application templates and supplemental forms from the Research Gateway IRB Application Templates, Help Guides, and Supplemental Forms page.

Guide	Use this guide to:
📖 New Study	Submit a New Study.
⏳ Continuing Review	Submit a Continuing Review.
📦 Migrated Studies	Find migrated studies, understand what information was and was not migrated from iRIS, and complete recommended first steps in ReGI.
🛠️ 1st Modification for a Migrated Study	Submit the first Modification in ReGI for an approved study migrated from iRIS (for changes beyond non-PI study team member updates).
🔄 Re-Submit an Unapproved iRIS Submission in ReGI	Resubmit an iRIS submission that was not migrated to ReGI. This includes: Studies or submissions that were submitted in iRIS but not approved in iRIS before the system change, and Active Exempt studies in iRIS.
👥 Study Team Member Changes (Do not use for PI changes)	Add or remove non-PI study team members on an approved study.
👤Principal Investigator (PI) Change	Change the study PI.
👥 Assign PI Proxies	Assign PI Proxies who can receive IRB notifications and submit IRB items on the PI's behalf.
👤Assign Primary Contact	Assign or update the study's Primary Contact for IRB notifications.
💬Respond to IRB Requests	Respond to IRB Request for Clarification, Modification, or Deferral
🚨Report New Information	Report New Information (RNI): Protocol Violations, Adverse Events, and other Safety Information
➕Adding a pSite - IREX	Add Participating sites (pSite) when utilizing IREX as the reliance documentation platform when UCSF is the single IRB.
🔵UCSF Relying - Blue	Create a new study SmartForm in (ReGI) when the study is relying on Advarra, WGC, Jaeb, CHS Fresno, or NCI.
🟡UCSF Relying - Gold	Create a new study SmartForm in (ReGI) when the study is relying on an Academic Medical Center (AMC), other academic institution, or other external IRB (not Advarra, WGC, Jaeb, CHS Fresno, or NCI).

📖Guidance Sheets

Guidance	Description
👥 PI Proxy Guidance	Download the PI Proxy Guidance for a comprehensive explanation of this role.

👁️Read-Only Access in Research Gateway IRB (ReGI)

📋Guest List Access: For Individuals Who Need Read-Only Access to Some Studies	The Guest List can be used to grant individuals read-only access to an IRB study – or multiple studies – in Research Gateway IRB. This guide explains how to add individuals to the Guest List and how individuals with this access can locate IRB study information.
🌐Global IRB Viewer Access: For Central Administration Staff	Global IRB Viewer access allows read-only access to all IRB submissions in Research Gateway IRB. This guide explains who can be granted this type of access, how to request Global IRB Viewer Access, and how individuals with this access can locate IRB study information.

🗣️Instructor-led Trainings

Instructor-led Research Gateway IRB (ReGI) trainings are designed to help study teams get up and running quickly with the system. Please see the training materials below.

Topic	What was covered
👋 Introduction to Research Gateway IRB (ReGI)	During this training, the following topics were covered: System navigation, preparing and managing IRB submissions (new studies, modifications, continuing reviews, and reportable new information), adding PI Proxies, responding to IRB requests, and creating a new OnCore record. 📹 Couldn't attend a training? Watch the recorded session. Contact us if you are having trouble viewing the video. This document includes the Attendee questions and panelist answers from three Introduction to ReGI training sessions. Please note that most of the answers are incorporated into our website guidance and user guides.
📦 Migrated Studies	During this training, the following topics were covered: Working with approved studies after they migrated from iRIS to Research Gateway IRB (ReGI), including how to find studies and identify what information did and did not migrate, locate approved documents, and manage key tasks such as adding PI Proxies, reviewing the SmartForm, linking to existing OnCore records, and accessing the IRB Application template. 📹 Couldn't attend a training? Watch the recorded session. Contact us if you are having trouble viewing the video.

Topic

What was covered

👋 Introduction to Research Gateway IRB (ReGI)

During this training, the following topics were covered:

System navigation, preparing and managing IRB submissions (new studies, modifications, continuing reviews, and reportable new information), adding PI Proxies, responding to IRB requests, and creating a new OnCore record.

📹 Couldn't attend a training? Watch the recorded session. Contact us if you are having trouble viewing the video.

This document includes the Attendee questions and panelist answers from three Introduction to ReGI training sessions. Please note that most of the answers are incorporated into our website guidance and user guides.

📦 Migrated Studies

During this training, the following topics were covered:

Working with approved studies after they migrated from iRIS to Research Gateway IRB (ReGI), including how to find studies and identify what information did and did not migrate, locate approved documents, and manage key tasks such as adding PI Proxies, reviewing the SmartForm, linking to existing OnCore records, and accessing the IRB Application template.

📹 Couldn't attend a training? Watch the recorded session. Contact us if you are having trouble viewing the video.