Category Archives: IREx Study Manager

Updated Feature: Allow a Site Closure for Sites Not Approved for a Current Version but have Initial Approval

Approvals, FRL, IREx Study Manager, Reviewing IRB

Previously, sites can only be closed on a study if the site has approval on the current version. The sIRB and Study Managers will now have the [+ Add Site Closure] option for sites that have received initial approval, even if they are not approved on the current study version. The Sites Closed page will list the version that the site had their last approval.

Updated Feature: More Flexible Combo Site Documentation

Approvals, Email Notifications, FRL, IREx Study Manager, Local Considerations, November 2021, Reviewing IRB, Status Summary Tab

A Combo Site occurs when one study team engages multiple Federalwide Assurances (FWAs) for a given study. Because sIRBs often review and approve Combo Sites separately – so as not to delay study activation at one site – IREx has added new flexibility for Combo Sites.

Most importantly, sites in a Combo can now be reviewed and approved by the sIRB separately. To facilitate sites being reviewed by the sIRB as quickly as possible, the notification that local considerations have been completed for a site in a Combo is now sent to Study Managers and sIRBs instantly, rather than requiring all sites be complete. Additionally, after a site is reviewed and approved by the sIRB, the site’s approval can be posted to IREx instantly, rather than requiring all sites in the Combo to have approval before the documents can be posted. Given that combo sites may have separate consent forms or receive approval at separate times, combo site approvals are posted for each FWA/site, like the other sites on the study.

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.

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.