Category Archives: FRL

New Feature: sIRBs and SMs Can Close Sites in IREx

Approvals, Coordinator, Edit Participating Sites, Email Notifications, FRL, IREx Study Manager, Relying HRPP, Reviewing IRB, September 2021, Status Summary Tab, Study PI

sIRBs and Study Managers can now close sites on studies. A reason or reasons for closure, date of closure, and determination letter are required to post a site closure. Closing a site sends a notification to the site’s HRPP and study team members and archives all past approvals so that no documents can be downloaded. Participating sites continue to have access to site closure documentation for 30 days after a site closure is submitted, after which the site cannot access the study in IREx. A listing of closed sites is available to sIRBs and Study managers on the Status Summary tab. For further information, see the Site Closure Quick Guide.

Bug Fixes – September 13, 2021

FRL, September 2021, System Enhancements/ Bug Fixes
Fixed: “Other” textbox works when documenting a study closure
Fixed: Documents attached to surveys included in API documentation
Fixed: “Confirm SSRP” step shows on To Do column of Reviewing IRB Dashboard
Enhanced: Updated date validation on study closure dialog
Fixed: One site of combo site declining engagement fully dissolves combo site
Fixed: Multisite Liaisons can edit/add study team members to studies

New Feature: sIRB Can Close Studies on IREx

Approvals, August 2021, Coordinator, Dashboard, Email Notifications, FRL, IREx Study Manager, Relying HRPP, Reviewing IRB, Status Summary Tab, Study PI

sIRBs can now close studies that are complete on IREx by uploading the reason and date of closure, as well as the IRB determination letter. Closing a study notifies sites that the study has ended. The study remains accessible to all registered sites after a closure is posted, and all past approvals become read-only. A record of sites’ reliance details and a history of sIRB site approvals are still available in all IRB exports for metrics. For instructions on how to close a study, see our Quick Guide.

Here is what you will see for a closed study:

  • Study page is grayed out with a Study Closed header at the top
  • Status Summary Tab shows as Closed in Approval column
  • IRB Dashboards show that a study has been closed
  • Versions box shows that a study has been closed
  • Exports show closed studies with date of closure

New Feature: Survey available to request new consortiums to be added to IREx for IRB/HRPP Liaisons and Study Managers

Edit Participating Sites, FRL, IREx Study Manager, July 2021, Relying HRPP

Last month, a new feature was created to add a consortium of sites on the Participating Sites dialog so that study managers no longer have to add each site individually to their studies if the study is part of a consortium. To support this feature, we created a new survey where an IRB/HRPP Liaison or Study Manager can request a new consortium be added to IREx. The sIRB or Study Manager can also find a link to this survey on the Participating Sites dialog when they select to add a consortium.

Bug Fixes – July 6, 2021

FRL, July 2021, System Enhancements/ Bug Fixes
Fixed: Institutional Profile opens from Site-specific Approvals Tab.
Fixed: Documents carried over from previous approval maintain correct upload date.
Fixed: Site-specific Info menu shows all options for Relying HRPP liaisons.
Fixed: Component sites can be added to a study if the main FWA has registered for the study.
Fixed: Event log opens for large studies.
Fixed: A combo site that registers as a singular site shows as a single site on the Status Summary tab
Fixed: Removed error when logging in for the first time and agreeing to Terms of Use.
Fixed: Status Summary export shows correct LOI status for component sites.