On the overall approval dialog, “Is Site Enrolling” has been revised to read “Will Lead Site enroll participants?” for clarity.
Category Archives: Reviewing IRB
New Feature: Study Managers can upload Overall Study/Lead Site Initial Approval
Previously, only the sIRB could upload the initial approval. Now, study managers can upload the initial approval after the sIRB confirms the Study-specific Reliance Plan (SSRP). The ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will appear on the Study Manager’s checklist when available for upload.
Categories & Users Impacted: Getting Started Checklist, Approvals, September 2022, Reviewing IRB, IREx Study Manager
New Feature: sIRB is notified after Study Manager publishes Overall Study/Lead Site Initial Approval
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.
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.
New Feature: SIRBs and Study Managers can Resend Study Notification to Sites
The sIRB and Study Manager can now re-notify/contact a site about a study by resending the “IREx study at your site” notification. This is done by clicking the site’s ‘Contacted’ status from the Status Summary tab. The subject line of the email notification will include the sender’s name who is re-contacting the site (e.g., “Jane Smith is resending your IREx Study Notification”). This feature is used to follow up with sites that have not yet started on the study.
Updated Feature: The Manage Version, site amendment pop-up has been updated
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.
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: The Manage Version, site amendment pop-up has been updated
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.
Updated Feature: Column header on the Participating Site Export is renamed
In the Participating Site Export, the column header, “dateInitialReviewApproved” is renamed to “dateLeadSiteInitialApproval” to help differentiate the date of initial approval for the Lead Site from relying sites.
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.