The amendment application is no longer required when uploading a study-wide and site-specific amendments in IREx.
Category Archives: IREx Study Manager
New Feature: Grant Relying Site Study Teams Immediate IREx Access
IREx now automatically grants the relying site study teams access to the platform when their site is notified of a study. Study team contacts receive login credentials and can log in immediately to view study details, access the sIRB initial approval documents, and collaborate with the lead study team. Study teams no longer have to wait for their Human Research Protection Program (HRPP) administrators to log in and confirm access – minimizing unnecessary waiting periods. However, the relying HRPP must confirm study participation before the study team can complete the PI Survey.
Reviewing IRBs and Lead Study Teams (“IREx Study Managers”) can use the Status Summary page in IREx to notify sites and grant study teams access to the study.
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: Include multiple study team contacts before notifying sites of a study
Lead Study Teams can now enjoy the flexibility of including multiple study team contacts before notifying sites of a study. IREx allows Lead Study Teams to list multiple investigators and/or ‘coordinators’ for each site involved in the study. This comprehensive approach enables you to include a diverse range of key personnel, such as regulatory specialists, clinical research associates, clinical research navigators, and more. Having multiple study team contacts enhances collaboration by keeping everyone informed, engaged, and up-to-date throughout the site onboarding process.
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.
Updated Feature: Allow Reviewing IRB Liaisons to give Site Coordinator Access
Reviewing IRB Liaisons can now give relying site coordinators access to their studies. Previously, only Study Managers were allowed to grant site coordinator access. Reviewing IRBs and Study Managers can give site coordinator access from the Participating Personnel dialog via the ‘+Grant Site Coordinator Access’ button and from the ‘+Add Site Coordinator Access’ button on the Approval History tab.
Update Feature: All sites on a study are now listed in the +Grant Site Coordinator Access site dropdown menu
The ‘+Grant Site Coordinator Access’ button on the Participating Personnel dialog will now list all participating sites on the study. Previously, it only listed sites that have registered on the study.
However, the sIRB and Study Manager will not be allowed to add coordinators to sites that have NOT yet registered on the study. If a site that has not yet registered is selected, a pop-up will appear with the following text:
“This site has not yet registered on the study. Study team members cannot access the study until their site registers.”
New Feature: Streamline Sharing and Notifying Relying Sites of new Continuing Review and Study-wide Amendment Approvals
Relying site approvals no longer have to be individually confirmed after publishing a continuing review or study-wide amendment. Now, if relying sites did not have site-specific changes, their approvals can be confirmed when adding the overall approval so that sites automatically get notified of the Continuing Review or Study-wide Amendment when the overall approval is published.
New Feature: Site Updates tab in the Overall Approval dialog is locked after publishing overall approval.
After the overall / lead site approval is published for a Study-wide Amendment or Continuing Review the ‘Site Updates’ tab will be locked. Any modifications to site-specific approvals can be made individually via the Relying Site Approvals dialog.
New Feature: When posting the lead site/overall approval, sIRBs and Study Managers can indicate whether approved sites had site-specific changes at Continuing Review and for Study-wide Amendments on “Site Updates” tab
A new tab – “Site Updates” – has been added when uploading continuing reviews and study-wide amendments. This new tab captures whether any approved sites had site-specific changes as part of the new approval (e.g., updated or newly stamped consent forms). Any enrolling sites that did not have changes are automatically marked as ‘approved’ and notified when the overall / lead site approval is published. The approval for sites with changes must be uploaded after publishing the lead overall / lead site approval.