Category Archives: Reviewing IRB

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documents using the Add Document button on the Onboarding taband keep this list of documents current by moving any outdated documents down under the ‘Archived Documents’ section using the Archive button.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

New Feature: Reviewing IRBs can now request Relying Sites update their Local Considerations throughout the life of a study

February 2024, FRL, IREx Study Setup, Reviewing IRB

In the IREx Study Setup, Reviewing IRBs/sIRBs can choose to have IREx notify relying sites when a study-wide amendment is posted, and request sites update their local considerations in IREx if necessitated by the study changes. If sIRBs choose this option, they can also opt to choose a number of days sites have to submit their updates in IREx. This feature is only available on studies in which the sIRB is collecting local considerations in IREx.

Updated Feature: Study Reports now shows which studies are capturing Local Consideration updates

Dashboard, February 2024, FRL, Local Considerations, Reviewing IRB

The Overall Study and Participating Site Report has a new column, ‘isCapturingLocalContextUpdates’ to indicate which studies in IREx are capturing Local Considerations updates for the life of a study. Reviewing IRBs can download the Overall Study Report (CSV) and the Participating Site Report (CSV) from their Reviewing Site’s Studies Dashboard from the Export menu.

New Feature: Reviewing IRBs can now upload additional documents to share with sites

FRL, IREx Study Setup, January 2024, Reviewing IRB

Reviewing IRBs can now indicate in the IREx Setup if they’d liked to provide additional documents to help facilitate the site’s local submission process. This question is found on the SIRB Instructions tab of the IREx Setup and defaults to ‘No.’ If selecting ‘Yes,’ the Reviewing IRB will be required to upload additional documents and a new ‘Documents’ tab will appear on the study page for all users to access the additional documents.