The first step for Study Managers on IREx is to add participating sites. This step has been made easier for consortium studies with the “select consortium of sites” option. Inform the IREx Administrators if you would like to establish a consortium. Once created, the SM can simply add all sites from a consortium at once. Sites can also be removed; plus, non-consortium sites can be added to any study in addition to consortium sites.
Category Archives: FRL
Updated Feature: Site-Specific Approval dates show for a review that has not been approved
When sIRB or SMs add a submitted and reviewed date, these dates now show even if there is no approval yet. This can help Relying Site study teams stay informed about whether the review has been submitted to the SIRB.
Updated Feature: Email notification includes helpful guidance when new sites added
When a site that has not joined IREx is listed on a study, the “Participating Sites Added to Study” email now includes helpful text to guide how the site HRPP/IRB can initiate access for their site through the Join IREx page. This is an existing email sent to Reviewing IRBs and SMs if either party adds new sites to a study, but now updated for clearer guidance.
Updated Feature: New Approval email notification includes additional guidance for PIs and Study Teams
The “New IRB Approval For Your Site” email, sent when the SIRB or SM has documented a new approval, now includes updated guidance on how PIs and study teams can access approved study documents for their site.
Updated Feature: Updated training links
Training links have been updated to go to our comprehensive training page, which includes helpful live and on-demand (via YouTube) trainings for all users.
Updated Feature: Enhancements to Document Organization and Display
Approval Documents in both Study-wide and Site-specific IRB approval tabs now include a “date uploaded” column and are sorted by ascending uploaded date. Now it is clearer which documents have been carried forward from past approvals and which documents are new.
Updated Feature: Added Site Amendment button on Study Wide Approvals tab for sIRBs and study managers
Study managers and sIRBs can now add a site amendment straight from the Study-Wide Approvals Tab under the Manage Version button.
Bug Fixes – June 11, 2021
| Fixed: “Your Profile” and “Verify Study Team” dialog tabs open on next page. |
| Fixed: Agreements YouTube video displays correctly on IREx Setup. |
| Fixed: Blank tabs on Multisite Liaison’s page to Verify Study Team Contact are removed. |
| Fixed: The site amendment dialog has been restored to require sIRB review dates. |
New Feature: How-to videos are embedded in the IREx Setup on Agreements tab.
Two videos are embedded in the IREx Setup on the “Agreement” tab to help sIRBs know (1) what agreements can be offered on a study and how to add them and (2) how to offer a non-SMART IRB Agreement to an existing study.
Updated Feature: Agreement Checker includes other Broad Reliance Agreements.
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.