After the overall / lead site approval is published for a Study-wide Amendment or Continuing Review the ‘Site Updates’ tab will be locked. Any modifications to site-specific approvals can be made individually via the Relying Site Approvals dialog.
Category Archives: FRL
New Feature: When posting the lead site/overall approval, sIRBs and Study Managers can indicate whether approved sites had site-specific changes at Continuing Review and for Study-wide Amendments on “Site Updates” tab
A new tab – “Site Updates” – has been added when uploading continuing reviews and study-wide amendments. This new tab captures whether any approved sites had site-specific changes as part of the new approval (e.g., updated or newly stamped consent forms). Any enrolling sites that did not have changes are automatically marked as ‘approved’ and notified when the overall / lead site approval is published. The approval for sites with changes must be uploaded after publishing the lead overall / lead site approval.
New Feature: New question included on ‘Add Continuing Review’ pop-up dialog
A new required question has been added on the ‘Add Continuing Review’ pop-up dialog after the question about whether the continuing review contained a study-wide amendment.
The new question asks:
Did the overall study’s previously approved consent form(s) change (e.g., edits or new IRB stamp)? [Yes/No]
New Feature: A ‘TIN’ bubble displayed on study pages and on the list of search results to indicate if a study is a Trial Innovation Network study
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
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.
Bug Fixes – October 13, 2022
| Fixed: PI Survey now requires response about whether the site has consent forms. |
| Fixed: Study Closure dialog no longer fails when trying to close a study in IREx. |
| Fixed: Error message no longer appears when trying to add a site closure. |
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.