For EFIC studies, a fourth local consideration survey is required for study teams to provide a summary of results after implementing their Community Consultation Plan (CCP). The study teams can upload their CCP Summary of Results reviewed by their local HRPP to IREx for sIRB review and approval.
Category Archives: Local Considerations
New Feature: New notification when site completes CCP Summary of Results Survey
A new email notification, ‘IREx Update: Site’s CCP Summary of Results Survey Complete’ is sent to the Lead Study Team/Study Managers to notify them a site has completed the required CCP Summary of Results Survey for an EFIC study. The sites’ status will display 4/4 surveys completed on the Status Summary tab. Study Managers can download uploaded documents from the local considerations export.
Updated Feature: Modified HRP Survey for EFIC study
A new question is included on the HRP Survey for EFIC studies. The question asks the HRPP to confirm their review of the Community Consultation Plan (CCP) outlined by their local study team. This is to ensure the local HRPP has reviewed and offered their suggestions for the plan and an option to upload any documentation of review/recommendations for the CCP.
Updated Feature: Modified PI Survey for EFIC study
A new question is included on the PI survey for EFIC studies. The question allows the study team to upload their proposed Community Consultation Plan (CCP) after it has been reviewed by their local HRPP. This allows the study team to use IREx to submit the plan to the sIRB for review. The Study Team Member or Coordinator can complete the PI Survey but the PI must attest and when changes are made.
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.