The Participating Site’s Studies Dashboard has been updated to help clarify that the local IRB number is noted with the PI name. The PI column is now labeled as, ‘PI (Local IRB #),’ and includes ‘IRB #’ in the column if a local IRB number was indicated by the relying HRPP.
Category Archives: Relying HRPP
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.
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 # of studies per site on the IREx Participating Institution webpage
The IREx Participating Institution page now displays a column (‘# Total Relying Studies’) that shows the total number of studies each site is participating in IREx.
Updated Feature: Introducing the Refreshed IREx Study Page with Streamlined Navigation
The IREx Study Page has a new look! All users will see the study title is now at the top of the study page, an info icon that contains study information and primary contacts, and a top navigation bar that provides quick access to frequently accessed pages.
The navigation bar includes easily accessible pages:
- Approvals Page: Stay on top of your study’s approvals with just a click! Effortlessly view and manage all the approvals associated with your study in one centralized location.
- Status Summary Page: Monitor the status of your study at a glance! The Status Summary page provides a comprehensive overview of your study’s progress, helping you track milestones and stay organized.
- Sites Page: [Reviewing IRB & Study Manager only] Access the Sites page directly from the top navigation bar to easily manage your sites; add/edit sites and include study team contact information for each site.
- Contacts Page: [Reviewing IRB & Study Manager only] Stay connected with key study personnel! Access the Contacts page to view study team contacts who have access to the study.
Updated Feature: Prevent Study Managers from being added as a relying site study team member
IREx will now prevent Study Managers from being added as a study team member (Coordinator or investigator) to a participating site on the same study. This will ensure all users have the appropriate access and Getting Started Checklists.
Update Feature: Prevent non-HRPP staff from being added outside of studies
HRPP/ IRB Liaisons have the option to ‘Add HRPP Staff/ Members’ from the homepage and from the ‘+add user’ button on the ‘Find other users’ page. To prevent study team members (IREx Study Managers, PIs, and Coordinators) from being added as HRPP/IRB staff, IREx shows a pop-up asking whether the new user is HRPP / IRB personnel or study team. If study team, the user is directed to add the new user on the appropriate 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.
Updated Feature: ‘Auto approved’ column included in Participating Site Report
The My Relying Studies Report (CSV) on the Participating Site Dashboard export has a new ‘auto Approved’ column to indicate whether the site’s approval was automatically when publishing the lead site’s approval. The column will show a value of ‘1’ if the site’s approval was automatically posted, which means the site did not have site-specific changes. A ‘0’ indicates the site’s approval was uploaded separately from the overall approval because it contained site-specific changes (e.g., updated or re-stamped consent forms).
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.