Relying HRPPs that have declined engagement during study registration, will now appear as “Non-Engaged Sites” in the blue box on the Sites page. These sites will no longer appear in the dropdown list to prevent the sIRB and Study Manager from adding the declined sites to the study. Reviewing IRBs and Study Managers can add a non-engaged site back on the study by going to the Status Summary tab to re-enlist the site.
Category Archives: Reviewing IRB
New Feature: The ‘Onboarding’ Tab is now available on all studies
Previously called the ‘Documents’ tab, the ‘Onboarding’ tab is an easily accessible place for Relying Sites to find any additional documents (i.e., Reviewing IRB SOPs, Reviewing IRB Communication Plans, Part 2 Consent Forms) that were uploaded by the Reviewing IRB or Study Manager to help facilitate sites’ local submission process.
Reviewing IRBs and Study Managers can upload additional documents using the Add Document button on the Onboarding taband keep this list of documents current by moving any outdated documents down under the ‘Archived Documents’ section using the Archive button.
Relying Sites that do not have initial approval will default to the Onboarding tab when accessing the study page. Relying sites will be able to access these documents, along with their sIRB instructions, for the life of the study.
New Feature: Reviewing IRBs can now request Relying Sites update their Local Considerations throughout the life of a study
In the IREx Study Setup, Reviewing IRBs/sIRBs can choose to have IREx notify relying sites when a study-wide amendment is posted, and request sites update their local considerations in IREx if necessitated by the study changes. If sIRBs choose this option, they can also opt to choose a number of days sites have to submit their updates in IREx. This feature is only available on studies in which the sIRB is collecting local considerations in IREx.
New Feature: Amendment Content can now be indicated when uploading a study-wide amendment
For studies capturing local consideration updates, Reviewing IRBs and/or Study Managers will see a new ‘Amendment Content’ section on the Add Study-Wide Amendment dialog. The content areas are informed by the SMART IRB local considerations guidance documents.
Updated Feature: Study Reports now shows which studies are capturing Local Consideration updates
The Overall Study and Participating Site Report has a new column, ‘isCapturingLocalContextUpdates’ to indicate which studies in IREx are capturing Local Considerations updates for the life of a study. Reviewing IRBs can download the Overall Study Report (CSV) and the Participating Site Report (CSV) from their Reviewing Site’s Studies Dashboard from the Export menu.
New Feature: Reviewing IRBs can now upload additional documents to share with sites
Reviewing IRBs can now indicate in the IREx Setup if they’d liked to provide additional documents to help facilitate the site’s local submission process. This question is found on the SIRB Instructions tab of the IREx Setup and defaults to ‘No.’ If selecting ‘Yes,’ the Reviewing IRB will be required to upload additional documents and a new ‘Documents’ tab will appear on the study page for all users to access the additional documents.
New Feature: Annual reminder to update Institutional Profile (IP) sent to HRPPs
IREx will now send an annual reminder to IREx Liaisons (IRB/HRPP personnel) from the date the institution last updated their Institutional Profile. The reminder is to encourage HRPPs to keep their IP up to date as state laws or institutional policies may change.
Updated Feature: Display site(s) listed on the study on the ‘Add Site’ dialog
From the Sites tab, the ‘Add Site’ dialog will now display a list of sites already listed on the study. This will serve as a quick glance to help the user reference what sites are already listed when adding new sites.
Updated Feature: Column added on the Overall Study Report to show study status closed/active
The columns on the Participating Site Report have been rearranged in the order we’d expect the dates to happen. Reviewing IRBs can access the Participating Site Report from their Reviewing Site’s Studies Dashboard.
Updated Feature: SS Tab Export: Capture Date Requested Agreements
The “Request Agreement Date” is now in the Status Summary Tab Export. The export will list only the first/original date requested agreements for a site. The Reviewing IRB and IREx Study Manager can access the export from the Status Summary Tab.