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New Feature: IREx provides tailored Agreement and Single IRB Instructions for sIRB studies

Agreements/ Reliance, FRL, IREx Study Setup, July 2023, Reviewing IRB

Single IRBs can now use IREx to provide tailored instructions to relying sites, significantly reducing administrative burdens and accelerating research timelines. When completing the IREx Setup, Single IRBs can include site instructions for:

  1. Executing Required Agreements: Instructions for executing the necessary agreements between the Single IRB and relying sites. No more one-size-fits-all approaches – adapt the instructions to communicate the agreement requirements for your study.
  2. Completing the Single IRB Process: Guide relying sites through the single IRB process with clear and concise instructions for both the relying site HRPP and study teams.

Note: After the sIRB confirms the instructions in the IREx setup, sIRBs or lead study teams (“IREx Study Managers”) can use the Status Summary page to send the instructions to sites.

View default instructions.

New Feature: Grant Relying Site Study Teams Immediate IREx Access

Email Notifications, FRL, IREx Access, IREx Study Manager, July 2023, Reviewing IRB, Status Summary Tab

IREx now automatically grants the relying site study teams access to the platform when their site is notified of a study. Study team contacts receive login credentials and can log in immediately to view study details, access the sIRB initial approval documents, and collaborate with the lead study team. Study teams no longer have to wait for their Human Research Protection Program (HRPP) administrators to log in and confirm access – minimizing unnecessary waiting periods. However, the relying HRPP must confirm study participation before the study team can complete the PI Survey.

Reviewing IRBs and Lead Study Teams (“IREx Study Managers”) can use the Status Summary page in IREx to notify sites and grant study teams access to the study.

Updated Feature: Introducing the Refreshed IREx Study Page with Streamlined Navigation

Coordinator, FRL, IREx Study Manager, July 2023, Relying HRPP, Reviewing IRB, Status Summary Tab, Study PI

The IREx Study Page has a new look! All users will see the study title is now at the top of the study page, an info icon that contains study information and primary contacts, and a top navigation bar that provides quick access to frequently accessed pages.

The navigation bar includes easily accessible pages:

  • Approvals Page: Stay on top of your study’s approvals with just a click! Effortlessly view and manage all the approvals associated with your study in one centralized location.
  • Status Summary Page: Monitor the status of your study at a glance! The Status Summary page provides a comprehensive overview of your study’s progress, helping you track milestones and stay organized.
  • Sites Page: [Reviewing IRB & Study Manager only] Access the Sites page directly from the top navigation bar to easily manage your sites; add/edit sites and include study team contact information for each site.
  • Contacts Page: [Reviewing IRB & Study Manager only] Stay connected with key study personnel! Access the Contacts page to view study team contacts who have access to the study.

Updated Feature: Include multiple study team contacts before notifying sites of a study

Edit Participating Sites, Email Notifications, FRL, IREx Study Manager, July 2023, Reviewing IRB

Lead Study Teams can now enjoy the flexibility of including multiple study team contacts before notifying sites of a study. IREx allows Lead Study Teams to list multiple investigators and/or ‘coordinators’ for each site involved in the study. This comprehensive approach enables you to include a diverse range of key personnel, such as regulatory specialists, clinical research associates, clinical research navigators, and more. Having multiple study team contacts enhances collaboration by keeping everyone informed, engaged, and up-to-date throughout the site onboarding process.

New Feature: Study Managers can upload Overall Study/Lead Site Initial Approval

Approvals, FRL, Getting Started Checklists, IREx Study Manager, Reviewing IRB, September 2022

Previously, only the sIRB could upload the initial approval. Now, study managers can upload the initial approval after the sIRB confirms the Study-specific Reliance Plan (SSRP). The ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will appear on the Study Manager’s checklist when available for upload.

Categories & Users Impacted: Getting Started Checklist, Approvals, September 2022, Reviewing IRB, IREx Study Manager

New Feature: sIRB is notified after Study Manager publishes Overall Study/Lead Site Initial Approval

Approvals, Email Notifications, FRL, Reviewing IRB, September 2022

The sIRB liaison(s) for a study will receive an email notification when the study manager has published the Overall Study/Lead Site Initial Approval. The subject line of this notification reads, “FYI: Overall Initial Approval Uploaded to IREx”. All study managers are also CC’ed on this email. No action steps are associated with this notification.

New Feature: sIRB is notified after Study Manager publishes any Study-wide Approval

Approvals, Email Notifications, FRL, IREx Study Manager, Reviewing IRB, September 2022

sIRB liaisons receiving notifications for a study will receive an email notification when the study manager has published any study-wide approval (e.g., Continuing reviews and study-wide amendments) in IREx. The subject line of this notification reads “FYI: Overall Approval Uploaded to IREx”. Study managers are also copied on this email. The email will list the type of approval and provide a link to the study. No action steps are associated with this notification.

Updated Feature: Removed ‘Add PI Info’ step on the Study Managers’ Getting Started Checklist

FRL, Getting Started Checklists, IREx Study Manager, September 2022

The ‘Add PI Info’ step has been removed from the study managers’ Getting Started Checklist to help streamline other actionable steps. The sIRB liaison and study manager can add PI information from the Edit Participating Site dialog when listing a site and from the Status Summary tab before notifying the sites’ access to the study.

Updated Feature: The ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will now appear at the top of the Study Manager checklist

Approvals, FRL, Getting Started Checklists, IREx Study Manager, September 2022

To help study managers prioritize their actions, the ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will not appear at the top of the Study Managers’ Getting Started Checklist when an initial approval, continuing review, or study-wide amendment is in progress. These steps disappear after the overall approval is published.