Category Archives: FRL

Update Feature: Prevent non-HRPP staff from being added outside of studies

HRPP/ IRB Liaisons have the option to ‘Add HRPP Staff/ Members’ from the homepage and from the ‘+add user’ button on the ‘Find other users’ page. To prevent study team members (IREx Study Managers, PIs, and Coordinators) from being added as HRPP/IRB staff, IREx shows a pop-up asking whether the new user is HRPP / IRB personnel or study team. If study team, the user is directed to add the new user on the appropriate study.

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.”

Updated Feature: Allow Reviewing IRB Liaisons to give Site Coordinator Access

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.

Bug Fixes – November 7, 2022

Fixed: Do not allow sIRB to be added as a participating site on a study
Fixed: Global Documents appear on the Approval History tab for study closures, which includes the IRB Documentation letter.
Fixed: Site Amendment dialog no longer includes questions about the lead site’s enrollment status and the publish banner.
Fixed: The current enrollment status of sites carries forward when the site’s approval is posted with the lead site.
Fixed: The Study Manager’s site affiliation can be selected in IREx Setup.
Fixed: Studies that are not capturing local considerations no longer send an email reminder to a relying site PI to complete the PI Survey .

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: 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.