- ReGI Submission Tips
- System User Guides
- GESCR User Guides
- Guidance Sheets
- Read-Only Access in Research Gateway IRB
- Training Videos and Materials
- Research Gateway IRB + OnCore
- VA SharePoint (for VA staff access)
💻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: | Last Updated |
|---|---|---|
| Start a Study | ||
| 📖 New Study | Submit a New Study. | 6/4/2026 |
| 📦 Migrated Studies | Find migrated studies, understand what information was and was not migrated from iRIS, and complete recommended first steps in ReGI. | 6/29/2026 |
| 🔄 Re-Submit an Unapproved iRIS Submission in ReGI | Resubmit an iRIS submission that was not migrated to ReGI. This includes:
| 7/1/2026 |
| Maintain an Approved Study | ||
| 🛠️ 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). | 9/11/2026 |
| 🛠️ Modifications for Non-Migrated Studies or Migrated Studies With an Approved IRB Application Document | Prepare and submit modifications for studies initially approved in ReGI or for the second and subsequent modifications to studies migrated from iRIS. | 9/14/2026 |
| 🛠️ Modification to Update Consent Form Approval Stamps | Update approved consent forms that were not updated with an IRB approval stamp date when a continuing review or modification is approved. | 8/25/2026 |
| ⏳ Continuing Review | Submit a Continuing Review. | 9/22/2026 |
| Manage Study Roles & Contacts | ||
| 👥 Study Team Member Changes (Do not use for PI changes) | Add or remove non-PI study team members on an approved study. | 9/15/2026 |
| 👤Principal Investigator (PI) Change | Change the study PI. | 6/22/2026 |
| 👥 Assign PI Proxies | Assign PI Proxies who can receive IRB notifications and submit IRB items on the PI's behalf. | 8/5/2026 |
| 👤Assign Primary Contact | Assign or update the study's Primary Contact for IRB notifications. | 7/10/2026 |
| Respond to the IRB | ||
| 💬Respond to IRB Requests | Respond to IRB Request for Clarification, Modification, or Deferral | 9/25/2026 |
| Report New Information (Post-Approval) | ||
| 🚨Report New Information | Report New Information (RNI): Protocol Violations, Adverse Events, and other Safety Information | 9/10/2026 |
| Reliance & External IRB Studies | ||
| ➕Adding a pSite - IREX | Add Participating sites (pSite) when utilizing IREX as the reliance documentation platform when UCSF is the single IRB. | 7/20/2026 |
| 🔵UCSF Relying - Blue | Create a new study SmartForm in (ReGI) when the study is relying on Advarra, WGC, Jaeb, CHS Fresno, or NCI. | 7/17/2026 |
| 🟡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). | 6/1/2026 |
| 🤝 UCSF Relying- Updates and Modifications to External IRB Reviewed Studies | Submit a Modification or an Update to a study reviewed by an external IRB. | 7/21/2026 |
| 🔍 UCSF Reviewing - Updating single site to multisite in ReGI | Update a migrated study from “single site” to “multi-site” in ReGI. Only perform this action after consultation with the reliance team. | 7/7/2026 |
| Reports & Data | ||
| 📊 IRB Custom Reports | Custom Reports provide a pre-defined view of ReGI data based on your system role and permissions. You can adjust filters, rerun reports, view the results in ReGI, or export the data. | 9/10/2026 |
💻GESCR User Guides
| 🧬GESCR - New Protocol | Submit a New GESCR Protocol | 8/14/2026 |
📖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)
| Guidance | Description | Last Updated |
|---|---|---|
| 📋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. | 8/27/2026 |
🗣️Training Videos and Materials
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:
📹 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:
📹 Couldn't attend a training? Watch the recorded session. Contact us if you are having trouble viewing the video. |
| 📋 "ReGI Submission Tips" IRB Webinar | This 33-minute webinar and presentation provides practical tips for navigating some of the most common challenges encountered when submitting IRB materials in ReGI. Topics covered include:
Note: The Q&A session is not included in the video. A written summary of the webinar Qs & A’s will be posted here shortly. |