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: FRL
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.”
New Feature: Improve the upload of Continuing Reviews and Study-wide approvals
After the sIRB or Study Manager uploads and publishes an ongoing approval for the overall study / lead site, a pop-up banner appears on the study page:
“Success! All previously approved sites are now listed as Pending on the Status Summary tab. Visit the Relying Site Approvals dialog to confirm sites were approved and upload/remove site-specific documents, as needed. Completing this step will notify the sites of the new approval.”
The pop-up banner is used to prompt the sIRB and Study Manager that previously approved sites’ status has changed to “Approval Pending” and to confirm the sites were approved and update any approval documents.
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.”