A ‘TIN’ (Trial Innovation Network) bubble appears next to study titles when searching studies and on each study page to indicate which studies are a TIN-supported
Category Archives: Approvals
Updated Feature: ‘Auto approved’ column included in Participating Site Report
The My Relying Studies Report (CSV) on the Participating Site Dashboard export has a new ‘auto Approved’ column to indicate whether the site’s approval was automatically when publishing the lead site’s approval. The column will show a value of ‘1’ if the site’s approval was automatically posted, which means the site did not have site-specific changes. A ‘0’ indicates the site’s approval was uploaded separately from the overall approval because it contained site-specific changes (e.g., updated or re-stamped consent forms).
Updated Feature: Clarified text regarding what happens after publishing an overall/lead site approval.
Before publishing an overall / lead site continuing review or study-wide amendment, IREx help text is provided to help the sIRB or Study Manager know what to expect when publishing an approval and what to do next. This text has been revised to ensure it is clear that sites without changes have been notified of the approval, but site-specific changes must still be uploaded and saved.
A yellow banner is also displayed after the overall / lead site approval is posted, and it too has been revised to describe what should happen next.
Updated Feature: Clarified “Is Site Enrolling” question on the overall approval dialog
On the overall approval dialog, “Is Site Enrolling” has been revised to read “Will Lead Site enroll participants?” for clarity.
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.
Updated Feature: The ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will now appear at the top of the Study Manager checklist
To help study managers prioritize their actions, the ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will not appear at the top of the Study Managers’ Getting Started Checklist when an initial approval, continuing review, or study-wide amendment is in progress. These steps disappear after the overall approval is published.
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: 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.