The sIRB liaison(s) for a study will receive an email notification when the study manager has published the Overall Study/Lead Site Initial Approval. The subject line of this notification reads, “FYI: Overall Initial Approval Uploaded to IREx”. All study managers are also CC’ed on this email. No action steps are associated with this notification.
Category Archives: Approvals
New Feature: sIRB is notified after Study Manager publishes any Study-wide Approval
sIRB liaisons receiving notifications for a study will receive an email notification when the study manager has published any study-wide approval (e.g., Continuing reviews and study-wide amendments) in IREx. The subject line of this notification reads “FYI: Overall Approval Uploaded to IREx”. Study managers are also copied on this email. The email will list the type of approval and provide a link to the study. No action steps are associated with this notification.
Updated Feature: The ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will now appear at the top of the Study Manager checklist
To help study managers prioritize their actions, the ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will not appear at the top of the Study Managers’ Getting Started Checklist when an initial approval, continuing review, or study-wide amendment is in progress. These steps disappear after the overall approval is published.
Updated Feature: Protocol document not included in the sort filter
On both the Study-wide IRB Approvals and the Approval History tab, the protocol is now pinned at the top of documents and not included if sorted. This is to help make it easier for users to find the protocol after sorting.
Updated Feature: FWA short name is displayed on the Approval History tab when component sites are listed on a study
For clarity, a site’s FWA short name and full component site name will show in the ‘View As’ menu of the Approval History tab for sIRBs, Study Managers, and HRPPs overseeing multiple FWAs on a study.
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.