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.
Category Archives: Local Considerations
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.
Updated Feature: Display Getting Started Checklists for study teams when given study access
PIs and Coordinators will now see their Getting Started Checklists when given access to a study. However, the ‘Complete PI Survey’ step will be unavailable until their HRPP registers for the study.
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.
New Feature: Streamlined Local Considerations documentation for HRPPs
IREx has simplified local considerations documentation by no longer requiring Relying HRPPs to upload their locally verified site-specific ICF(s) to the HRP Survey. Now, Coordinators or Investigator can upload the locally verified ICF(s) to the PI Survey for the sIRB to review. HRPPs are also no longer required to validate their site’s responses to the PI Survey; however, responses can still be viewed and edited, if needed.