Category Archives: FRL

New Feature: Reviewing IRBs can enable turning off approval notifications

Approvals, Email Notifications, FRL, IREx Study Manager, IREx Study Setup, May 2025, Reviewing IRB

To give more flexibility to Reviewing IRBs and Study Managers in their communication with study teams, IREx now allows for approval notifications to be turned OFF on a study-by-study, approval-by-approval basis. A new question in the IREx Setup, “Would you like to allow turning off study notifications?” lets Reviewing IRBs enable this feature and allow turning off IREx approval notifications and updates for the lead site/overall study and relying sites. Turning off notifications can be useful when making corrections (date correction, updated document) to an existing approval.

Updated Feature: IREx Metrics available on website

FRL, May 2025

A new banner at the top of the IREx website includes the following metrics:

  • Institutions – # of participating institutions in IREx
  • Studies – # of studies in IREx
  • Reliances – Total # of participating sites with cede decision
  • HRPP Liaisons – # of active HRPP Liaison roles in IREx
  • Lead Study Members – # of active IREx Study Manager roles in IREx

Updated Feature: IREx surveys and PDFs now support line breaks

FRL, Institutional Profile, Local Considerations, May 2025, Relying HRPP, Reviewing IRB

To make reading easier for all HRPPs (and nicer-looking PDFs), the IREx IP now supports line breaks in open text fields. Line breaks appear in the web view and PDFs of the Institutional Profile (along with the HRP and PI surveys). Liaisons can edit existing/completed IP and HRP survey responses to include line breaks, and the breaks will appear after submitting the changes.

Bug Fixes – May 7, 2025

FRL, May 2025, System Enhancements/ Bug Fixes
Enhanced: If a site was contacted prior to SMART V3, display the study on the Participating Site’s Studies page to know they need to register.
Fixed: SMART IRB agreement now defaults to V3 instead of V1/V2.
Fixed: Allow site to rely using the Other Reliance Agreement (ORA) if executed the ORA and SMART V1/V2 is locked.
Fixed: Relying HRPPs can add additional engaged sites on the registration page.

New Feature: SMART IRB Agreement V3.0 now supported in IREx

Agreements/ Reliance, April 2025, FRL, IREx Study Setup, Relying HRPP, Reviewing IRB

As of March 17, 2025, institutions must join SMART IRB Agreement V3.0 to establish any new reliance agreements with SMART IRB. IREx will update SMART IRB V3.0 signatory statuses to ensure HRPPs can cede review without delay. For existing IREx studies, Reviewing IRBs must designate SMART IRB Agreement V3.0 as the reliance agreement in the IREx Setup for sites that have NOT yet ceded review. The Reviewing IRB and Relying sites CANNOT cede review in IREx until both have signed SMART IRB V3.0.

Updated Feature: Allow users to Replace Draft protocol documents until approval is published

Approvals, FRL, IREx Study Manager, March 2025, Reviewing IRB

When Reviewing HRPPs or Study Managers are uploading their approval documents, they must either ‘Accept’ the draft protocol or ‘Replace Draft.’ They can use the Replace Draft button to replace the protocol as many times as they need until the approval has been published. They still must ‘Accept’ the protocol before they can publish.