Category Archives: FRL

Bug Fixes – October 2, 2023

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

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

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.