On the Study-wide IRB Approvals tab for sIRBs and Study Manager, the “+Add Site Amendment” button on the Manage Version tab has been updated to include pop-up text directing users, “To add a SITE amendment click on the Approval History tab”. This is to reflect the changes where sIRBs and Study Managers can add site amendments from the Approval History tab.
Category Archives: IREx Study Manager
Updated Feature: The Status Summary tab export now captures all dates sites were contacted
The Study Summary tab export will now include all dates a site was contacted. This export feature is only available to the Reviewing IRB and Study Manager(s) of a study.
New Feature: SIRBs and Study Managers can Add Site Coordinator Access to IREx
IREx now allows sIRBs and Study Managers to give coordinator access at sites that have registered for their study. For convenience, sIRBS and Study Managers can give coordinators access from:
- the Approval History tab, select the site from the View As dropdown and select +Add Site Coordinator Access from the site menu.
- the Participating Personnel dialog, select the +Grant Site Coordinator Access.
View this Add Site Coordinator Access Quick Guide for reference.
New Feature: An email notification is sent to the PI when a new coordinator is added at their site.
When a sIRB or Study Manager gives a site coordinator access to their study, an email notification, “New Coordinator Added” is sent to the PI. The email lists the study title, the sIRB Liaison or Study Manager who added the coordinator, site name, new coordinator name and email, and link to the study.
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.