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.
Category Archives: IREx Study Manager
Updated Feature: Enhancements to sIRB and Participating Studies Dashboards
Filters have been added to Reviewing Site’s Studies and Participating Site’s Studies dashboards to refine the studies viewed. The sIRB can filter their Reviewing Site’s Studies to only view Ongoing Studies, hiding studies where all sites have a current approval. Furthermore, IRBs/HRPPs in the Trials Innovation Network (TIN) can filter by TIN Only studies and non-TIN only studies.
The Participating Site Dashboard now shows the Local IRB Number, which is an optional field on the HRP survey filled out by the Relying Site HRPP. This same number can also be viewed in the Site-Specific Approvals tabs.
The Participating Site Dashboard now shows the date the IRB approved the site under “To Do”
These enhancements were added for quick viewing and efficient searching.
Updated Feature: Enhancements to the Agreement Checker
The Agreement Checker is a helpful tool on the IREx homepage which helps see if potential sites have already executed reliance and broad indemnification emails for a selected sIRB. We have made enhancements to make this tool easier to use and more visually appealing. There is added informational text explaining that sites are only required to execute one reliance agreement offered on a study, even if they have executed multiple. The SMART 1, SMART 2, and Other Reliance columns have been shaded to show that all are considered a reliance agreement. The Other Reliance Agreement and Indemnification columns have been updated with an easy-to-spot ✔️check mark symbol. The csv export includes the full FWA number.
Updated Feature: Add a consortium of sites to studies in the Participating Sites Dialog
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.
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: 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.
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.