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.
Category Archives: February 2024
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: Modified amendment approval email notification
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.
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. |