| Fixed: Reinstated document filters on the Study-wide IRB Approval tab |
| Fixed: Allow study contacts to view approvals for all sites if listed as part of a combo site. |
| Fixed: Overall study Initial Approvals dialog now displays calendar on Key Dates tab. |
| Fixed: IRB Approval Documentation again shows as ‘Required’ on Relying Site Approvals dialog if an existing file is removed. |
| Fixed: Consents & Assents document type again show as ‘Required’ on the Site Amendment dialog if an existing file is removed. |
| Fixed: IREx Study Setup includes appropriate Indemnification options when selected for a study. |
Category Archives: FRL
New Feature: Reorganized Site Approvals on the NEW ‘Approval History’ tab
Relying Sites can now access ALL approval documents from a single tab. IREx has combined the Study-wide and Site-specific IRB Approvals tabs for relying sites into a single ‘Approval History’ tab to simplify navigation. On the Approval History tab, the current approval is displayed first followed by all past approvals in descending order. The Reviewing IRB and Study Manager can use the Approval History tab to view approvals shared with a specific site.
New Feature: Filter on the Approval History tab
The filter option on the Approval History tab allows users to filter approvals by review type such as, Amendments and Continuing Reviews. The filters help users easily find an approval shared by the sIRB.
New Feature: Capture Amendment number for Study-wide and Site-specific Amendments
The Reviewing IRB and Study Manager can now enter an Amendment number and description when uploading approvals for study wide amendments and site-specific amendments. The Amendment number is an optional field used to help study teams identify specific amendments.
New Feature: Amendment number displayed next to approval type
The Amendment number and description, if provided by the sIRB or Study Manager, will be displayed on the Study-wide IRB Approvals and Approval History tab next to the approval type such as Study-wide Amendments, Continuing + Amendments, and Site Amendments (Approval History tab only).
New Feature: Amendment number included on approval notifications
The Amendment number and description, if provided by the sIRB or Study Manager, will be included in the table of the approval notification email sent to relying site HRPPs and study teams.
New Feature: ‘Change Summary’ label included next to Amendments
A ‘change summary’ label is included next to the Study-wide Amendments and Site Amendments approval type. Users can hover over the change summary label to quickly view the change summary description entered for that amendment.
New Feature: ‘View As’ menu on Approval History tab for users with multi-site access
sIRB Liaisons, Study Managers, Multi-site HRPP Liaisons and combo site PIs will see a ‘View As’ menu provided on their Approval History tab. They can select a site from the dropdown to view the approval for that site.
Updated Feature: Add Site Amendments and Site Closures on Approval History tab
After selecting a site from the View As menu on the Approvals History tab, the sIRB and Study Manager can add a site amendment and site closure for the site using the menu icon on the right side of the current approval.
Updated Feature: Publish Approval text is updated
Clarifying text has been included to the pop-up that appears when uploading an approval to indicate: “Publish Lead Site / Overall approval. Sites are not notified and cannot view these documents until their site approval is uploaded and saved.”