Category Archives: Study PI

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

Updated Feature: Agreement Checker includes other Broad Reliance Agreements.

Agreements/ Reliance, April 2021, Coordinator, FRL, IREx Study Manager, Relying HRPP, Reviewing IRB, Study PI

The Agreement Checker, which can be accessed from the IREx homepage after logging in, has been updated to reflect whether relying sites have executed any non-SMART reliance agreements with the selected single IRB. The Agreement Checker also reflects whether relying sites have executed a broad indemnification agreement with the selected single IRB. Study-specific agreements are not reflected in the Agreement Checker since execution of those agreements cannot count towards other studies.

Updated Feature: New Document Types on Approvals

Approvals, Coordinator, FRL, IREx Study Manager, June 2020, Relying HRPP, Reviewing IRB, Study PI

Document types are used in IREx to help manage files associated with a study’s approval. For clarification, IREx has renamed Consents to Consents & Assents, and added document types for Grant Application, Measures, Recruitment & Advertisements, and Other IRB Approved Documents. The new categories will make it easier for users on IREx to find their study documents.