Relying site approvals no longer have to be individually confirmed after publishing a continuing review or study-wide amendment. Now, if relying sites did not have site-specific changes, their approvals can be confirmed when adding the overall approval so that sites automatically get notified of the Continuing Review or Study-wide Amendment when the overall approval is published.
Category Archives: October 2022
New Feature: Lead site consents will carry forward on Continuing Reviews if they did not change
Previously, IREx required new consent forms to be uploaded at the time of continuing review. However, when sIRBs do not re-stamp consents at the time of continuing review, a new consent is not approved and therefore a new version should not be uploaded. Now, sIRBs and Study Managers can indicate that the consent(s) was not changed and carryforward the currently approved consent form.
New Feature: Site Updates tab in the Overall Approval dialog is locked after publishing overall approval.
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.
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. |