Reviewing IRB Liaisons can now give relying site coordinators access to their studies. Previously, only Study Managers were allowed to grant site coordinator access. Reviewing IRBs and Study Managers can give site coordinator access from the Participating Personnel dialog via the ‘+Grant Site Coordinator Access’ button and from the ‘+Add Site Coordinator Access’ button on the Approval History tab.
Category Archives: IREx Study Manager
Update Feature: All sites on a study are now listed in the +Grant Site Coordinator Access site dropdown menu
The ‘+Grant Site Coordinator Access’ button on the Participating Personnel dialog will now list all participating sites on the study. Previously, it only listed sites that have registered on the study.
However, the sIRB and Study Manager will not be allowed to add coordinators to sites that have NOT yet registered on the study. If a site that has not yet registered is selected, a pop-up will appear with the following text:
“This site has not yet registered on the study. Study team members cannot access the study until their site registers.”
New Feature: Streamline Sharing and Notifying Relying Sites of new Continuing Review and Study-wide Amendment Approvals
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.
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: 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