The Getting Started Checklist has been relabeled to “Checklist.” IREx removed the “Getting Started” label since the Checklist can be used after a site receives initial approval (e.g., edit local considerations and adding study contacts). Reviewing IRBs and Study Managers also continue to use the Checklist for ongoing approvals for the life of the study.
Category Archives: FRL
Updated Feature: “Not Approved” status now hidden on the Status Summary tab until site completes all steps
On the Status Summary Tab, the “Not Approved” status is now hidden until the site completes all steps needed for sIRB review. These steps include the completion of agreements, reliance decision, and local considerations if applicable for the study. This is to ensure a site has completed all necessary steps before site approval is uploaded.
Bug Fixes – February 13, 2024
| Enhanced: Modified Primary Study Team Contacts dialog to allow Reviewing IRB’s to add a Study Manager first and be able to indicate if also PI. |
| Enhanced: IREx administrators can now set a protocol to draft if requested by the sIRB and/or Study Manager. |
| Enhanced: API will now push the sponsor name or ‘Not Designated’ to IREx instead of defaulting to ‘Other’. |
| Enhanced: Study Managers will now see the ‘Edit Study Info’ menu before initial approval is published. |
| Fixed: New study team contacts added are now included on the study access notification when a site is re-contacted. |
| Fixed: Access notification no longer sending to PI not engaged on study. |
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.
Bug Fixes – January 4, 2024
| Enhanced: Envelope icon added on the ‘Agreements Complete’ button to signify user can request agreements. |
| Fixed: Removed the HTML code displayed on the SSRP when clicking site’s ‘Started’ status on the Status Summary tab. |
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.
Updated Feature: Allow to select multiple sponsors in the ‘Create a Study’ dialog
Reviewing IRBs can now select multiple sponsors when creating a new study.
If ‘other’ is selected, the Reviewing IRB will be required to enter the other sponsor’s name and add multiple other sponsors as needed.