Category Archives: Study PI

New Feature: The ‘Onboarding’ Tab is now available on all studies

Coordinator, FRL, IREx Study Manager, May 2024, Relying HRPP, Reviewing IRB, Study PI

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documents using the Add Document button on the Onboarding taband keep this list of documents current by moving any outdated documents down under the ‘Archived Documents’ section using the Archive button.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

Coordinator, Email Notifications, FRL, May 2024, Relying HRPP, Study PI

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: Relying sites can now edit the HRP and PI Survey after receiving Initial Approval

Coordinator, February 2024, FRL, Local Considerations, Relying HRPP, Study PI

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: Renamed ‘Add Site Coordinator Access’ from the Approval History tab

Coordinator, FRL, IREx Access, IREx Study Manager, November 2023, Reviewing IRB, Study PI

The ‘Add Site Coordinator Access’ menu option on the Approval History tab, has been renamed to ‘Add Study Team Access’. The Reviewing IRB and Study Managers can now give additional or new PIs access to the study using the ‘Add Study Team Access’ dialog at any time. Previously, they were only able to give coordinators access.

Updated Feature: Introducing the Refreshed IREx Study Page with Streamlined Navigation

Coordinator, FRL, IREx Study Manager, July 2023, Relying HRPP, Reviewing IRB, Status Summary Tab, Study PI

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.