On EFIC studies, the Study Manager Checklist step ‘Upload Relying Site Approval’ will be renamed to ‘Upload Relying Site Accepted CCP or Approval’. This is to let the Study Manager know a site can either receive the Reviewing IRB’s acceptance of their local Community Consultation Plan or receive initial study approval depending on which stage the site is at in the EFIC process.
Category Archives: Getting Started Checklists
Updated Feature: PI and Study Team Members Checklist for EFIC
The PI and Study Team Members’ Checklist will include new steps when participating on an EFIC study. The steps include Awaiting CCP Acceptance and Upload the CCP Summary of Results.
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.
New Feature: New steps added to the Reviewing IRB Getting Started Checklist
Reviewing IRBs now have a ‘Request Agreements’ step on their Getting Started Checklist when selecting ‘sIRB only’ in the study setup for whom can use IREx to send instructions for executing the required agreements. Reviewing IRBs will also have a new ‘Manage Agreements’ step on their checklist if there are sites with incomplete agreements listed on the study – when clicked, the Manage Agreements dialog will open for the Reviewing IRB to enter executed agreements for relying sites.
Updated Feature: Updated Reviewing IRB Getting Started Checklist
Reviewing IRBs now have a ‘Create Study’ step on their Getting Started Checklist. Clicking the step opens the ‘Edit Study’ dialog that allows the Reviewing IRB to make changes to the study title, short title, study summary, NCT#, and sponsor information.
Updated Feature: Updated Study Manager Getting Started Checklist
The IREx Study Manager’s Getting Started Checklist has a new ‘Request Agreements’ step. This step lets the Study Manager know they can send a notification to request sites’ complete the required study agreements. Also, the ‘Grant Site Access’ step now displays a pop-up with helpful information on granting sites access.
Updated Feature: Updated Study Team Getting Started Checklist
Relying site study teams now have a ‘Awaiting Reviewing IRB Approval’ step on their Getting Started Checklist. This step was added to let the PI and Coordinator know that after completing their steps in IREx, the next step is waiting for the sIRB to approve their site.
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.
New Feature: Study Managers can upload Overall Study/Lead Site Initial Approval
Previously, only the sIRB could upload the initial approval. Now, study managers can upload the initial approval after the sIRB confirms the Study-specific Reliance Plan (SSRP). The ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will appear on the Study Manager’s checklist when available for upload.
Categories & Users Impacted: Getting Started Checklist, Approvals, September 2022, Reviewing IRB, IREx Study Manager
Updated Feature: The ‘Track Site Progress on Status Summary’ step on the Study Manager checklist has been renamed
The ‘Track Site Progress on Status Summary’ step on the study managers’ Getting Started Checklist has been renamed to ‘View Site Progress on Status Summary’. This step is available once a site has been added to the study.