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).
Category Archives: Relying HRPP
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.
New Feature: Approved sites’ status on new reviews change to “Approval Pending”
In the past, when a new review is added to a study in IREx, sites’ status changed from “Approved” to “Not Approved” since they haven’t been shared the new approval yet. To improve clarification and uploading of new approvals the approved site’s status will now change to “Approval Pending” until the sIRB or Study Manager shares the new approval with the site.
Updated Feature: Hide Versions side bar on Study Page
The Versions side bar has been removed from the IREx study page. In the past, the Versions panel was used to locate past approvals but is no longer needed as sites can view all of their approvals on the Approval History tab. The sIRB and Study Manager can view all study-wide approvals on their Study-wide IRB Approvals tab.
Updated Feature: Sites can Download All approvals in one or by groups
Relying sites can use the Download All button to download both the Global (study-wide IRB approved) and Site-specific Documents. Sites can also download groups of approval documents by using the corresponding Download button or individual documents by clicking the document name.
Updated Feature: Approval notifications include new Approvals Quick Guide
All relying site approval notifications are updated to include text and a link to the Approvals Quick Guide for helping study teams locate their approval documents:
“*NEW* We’ve made accessing your approval documents more user friendly – use this Quick Guide to see changes.”
Updated Feature: Date Added is now Date Approved
For better clarification, the Date Added column has changed to ‘Date Approved’ to indicate the date documents were approved on the Study-wide and Site-Specific IRB Approvals tabs. SIRBs and Study Managers can also see the Date Approved column when uploading approvals for the Lead Site and Relying Sites.
Updated Feature: The Determination Letter Has Been Renamed to “IRB Approval Documentation”
The Determination Letter document type has been renamed to “IRB Approval Documentation” for better clarification since not all institutions call the approval from the IRB a determination letter.