The amendment approval notification sent to relying sites has been modified for studies capturing local consideration updates for the life of a study. The email subject changed from, “IREx: New IRB Approval For Your Site.” to “ATTN: Approved changes may require local review.” A new Amendment Content section outlines the type of changes and a link on how to edit the surveys is also included.
Category Archives: FRL
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.
Updated Feature: Relying sites can now edit the HRP and PI Survey after receiving Initial Approval
Prior to February 2024, the HRP and PI Survey was not editable after a relying site received initial approval in IREx. Now, the Relying HRPP can edit both the HRP and PI Survey and the relying site Study Team Members and PI can edit the PI Survey after initial approval, as needed. Editing the surveys in IREx helps align any site changes. IREx will notify the Reviewing IRB and Study Managers when changes to the surveys are made.
Updated Feature: HRP and PI Survey PDFs will now include Last Modified Date
The HRP and PI Survey PDFs will now display the date the survey was last updated as ‘Last Modified DD/MM/YYYY’. Now that relying sites can edit their HRP and PI Surveys after receiving initial approval – documenting the date the survey was last modified provides transparency.
Updated Feature: Relabeled Getting Started Checklist
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.
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.