Category Archives: Approvals

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: Data exports for sIRBs and Relying Site HRPPs

Agreements/ Reliance, Approvals, Dashboard, FRL, June 2021, Relying HRPP, Reviewing IRB

sIRB and HRPP liaisons can now export a csv file to quickly view and analyze data for studies, including dates for registration, reliance, and approvals. The sIRB can utilize the export to evaluate processes and assess efficiency (time to approval) and workload (number of relying sites). Relying HRPPs can also export data to efficiently view all studies in which they are participating, the SIRBs serving for those studies, and dates for registration, reliance, and approvals. Access this feature through the top righthand side of both Reviewing Site’s Studies and Participating Site’s Studies dashboards under “Exports.”

Updated Feature: Capture additional timepoints during Lead & Relying Site Approvals

Approvals, FRL, IREx Study Manager, June 2021, Local Considerations, Relying HRPP, Reviewing IRB

When capturing Lead and Relying Site Approvals, the sIRB and SM can now capture additional timepoints in the review process, such as the date the sIRB requested changes from PI and when those changes were received. Additional IRB review dates can also be captured if a study required multiple reviews. Local Review dates have been moved to the HRP survey for studies capturing Local Considerations to streamline the date capture. Local review dates have been removed for studies not capturing Local Considerations, since those sIRBs have chosen to track local considerations outside of IREx. The Status Summary Tab export, Reviewing Site Dashboard export, and Participating Site dashboard include these additional fields. These additional dates are optional but may help in achieving a more granular timeline of the sIRB review process.