Category Archives: FRL

Updated Feature: The Sites page now displays Non-Engaged Sites

Relying HRPPs that have declined engagement during study registration, will now appear as “Non-Engaged Sites” in the blue box on the Sites page. These sites will no longer appear in the dropdown list to prevent the sIRB and Study Manager from adding the declined sites to the study. Reviewing IRBs and Study Managers can add a non-engaged site back on the study by going to the Status Summary tab to re-enlist the site.

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

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documents using the Add Document button on the Onboarding taband keep this list of documents current by moving any outdated documents down under the ‘Archived Documents’ section using the Archive button.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

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.”

Bug Fixes – April 9, 2024

Fixed: Study closure notifications no longer sent to previously participating sites removed from a study.
Fixed: Study Managers can now ‘select a site’ from the dropdown on the Add A Contact box to add other Study Managers.
Fixed: The “Approved” status on the Status Summary tab is displaying for previously approved sites with edited SSRPs.