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.
Category Archives: Study PI
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: SIRBs and Study Managers can give a new Site PI Access to IREx when adding a Site Amendment
If a site PI is changed after the site receives initial approval, sIRBs and Study Managers can give the new PI study access via a site amendment. This avoids asking the relying HRPP to login to IREx and add the new PI.
View this Add Site Amendment 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.
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: 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.