Category Archives: FRL

Bug Fixes – October 2, 2023

FRL, October 2023, System Enhancements/ Bug Fixes
Fixed: Prevent IRB Application document from displaying a custom name when pushed via API.
Fixed: Allow combo site study teams to access all documents at all sites engaged.
Fixed: Study Managers can now delete other study managers in the primary contacts dialog.
Fixed: Email notification indemnification status for component sites.
Fixed: Able to add additional contacts at sites with no study access.

Bug Fixes – August 7, 2023

August 2023, FRL, System Enhancements/ Bug Fixes
Fixed: Pushing the published initial approval to IREx via API
Fixed: Update VUMC documents to use new sync ID standard (API)
Fixed: Study managers not required in the relying site contacts dialog.
Fixed: Study team contacts with access can remove other contacts at their site.
Fixed: Addressing the correct user role on the access email notifications.
Fixed: Display investigators name on access notifications when multiple investigators are listed.
Fixed: Display the Reviewing IRB contact and Study Manager(s) on the study info icon when on the Sites and Contacts pages of a study.
Fixed: Publish relying site initial approvals via API.

New Feature: IREx provides tailored Agreement and Single IRB Instructions for sIRB studies

Agreements/ Reliance, FRL, IREx Study Setup, July 2023, Reviewing IRB

Single IRBs can now use IREx to provide tailored instructions to relying sites, significantly reducing administrative burdens and accelerating research timelines. When completing the IREx Setup, Single IRBs can include site instructions for:

  1. Executing Required Agreements: Instructions for executing the necessary agreements between the Single IRB and relying sites. No more one-size-fits-all approaches – adapt the instructions to communicate the agreement requirements for your study.
  2. Completing the Single IRB Process: Guide relying sites through the single IRB process with clear and concise instructions for both the relying site HRPP and study teams.

Note: After the sIRB confirms the instructions in the IREx setup, sIRBs or lead study teams (“IREx Study Managers”) can use the Status Summary page to send the instructions to sites.

View default instructions.

New Feature: Grant Relying Site Study Teams Immediate IREx Access

Email Notifications, FRL, IREx Access, IREx Study Manager, July 2023, Reviewing IRB, Status Summary Tab

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

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.

Updated Feature: Include multiple study team contacts before notifying sites of a study

Edit Participating Sites, Email Notifications, FRL, IREx Study Manager, July 2023, Reviewing IRB

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.