| Fixed: SIRBs/SMs can now press the enter button when selecting and adding sites on the Edit Participating Sites dialog. |
| Fixed: The outdated ‘Site review’ link has been removed from the Site-specific Info dropdown menu for Relying HRPPs. |
Category Archives: FRL
Bug Fixes – December 16, 2022
| Fixed: SIRBs/SMs can now add site coordinators at FWA-Component sites in the +Grant Site Coordinator dialog |
| Fixed: Liaisons are prevented from adding PIs and Coordinators as “Users” in IREx. |
Updated Feature: Prevent Study Managers from being added as a relying site study team member
IREx will now prevent Study Managers from being added as a study team member (Coordinator or investigator) to a participating site on the same study. This will ensure all users have the appropriate access and Getting Started Checklists.
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.
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: The ‘isCollectingLocalContext’ column is now included in the Participating Site export
The Participating Site Report now includes, ‘isCollectingLocalContext’ column to indicate whether local considerations are expected for the study. If not, you will not see or expect any dates for the HRP Survey or PI Survey being completed. A one (1) indicates the study is collecting local considerations.
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.