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.
Category Archives: Relying HRPP
Updated Feature: Dates captured for EFIC studies now included on exports
The Participating Site Report and Status Summary Tab Report now includes columns that capture dates when the CCP was submitted, reviewed, and approved for an EFIC study. The exports will also include dates the study teams complete the CCP Summary of Results Survey and date PI Attested to the summary. Reviewing IRBs can access the reports from the Export menu on the Reviewing Site’s Studies Dashboard. Relying HRPPs can access their reports from the Participating Site’s Studies Dashboard. The Status Summary Tab Report is available for Reviewing IRBs and Study Managers on the Status Summary Tab.
Updated Feature: The Sites page now displays Non-Engaged Sites
Relying HRPPs that have declined engagement during study registration, will now appear as “Non-Engaged Sites” in the blue box on the Sites page. These sites will no longer appear in the dropdown list to prevent the sIRB and Study Manager from adding the declined sites to the study. Reviewing IRBs and Study Managers can add a non-engaged site back on the study by going to the Status Summary tab to re-enlist the site.
New Feature: The ‘Onboarding’ Tab is now available on all studies
Previously called the ‘Documents’ tab, the ‘Onboarding’ tab is an easily accessible place for Relying Sites to find any additional documents (i.e., Reviewing IRB SOPs, Reviewing IRB Communication Plans, Part 2 Consent Forms) that were uploaded by the Reviewing IRB or Study Manager to help facilitate sites’ local submission process.
Reviewing IRBs and Study Managers can upload additional documents using the Add Document button on the Onboarding taband keep this list of documents current by moving any outdated documents down under the ‘Archived Documents’ section using the Archive button.
Relying Sites that do not have initial approval will default to the Onboarding tab when accessing the study page. Relying sites will be able to access these documents, along with their sIRB instructions, for the life of the study.
Update Feature: Updated the sIRB Instructions to reference the ‘Onboarding’ tab
Sites receive the sIRB instructions in the “IREx Access and Single IRB Instructions” email when they are notified about the study. The purple text on the sIRB Instructions has been updated to say, “The overall/lead site approval is available in IREx on the Approvals tab of the study page. Use the Onboarding tab to view any additional documents shared by the sIRB and/or lead study team. Use these documents to prepare your local submission and initiate the reliance process at your site.”
Updated Feature: Modified column on Participating Site’s Studies Dashboard
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.
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.