Category Archives: FRL

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documents using the Add Document button on the Onboarding taband keep this list of documents current by moving any outdated documents down under the ‘Archived Documents’ section using the Archive button.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

Update Feature: Updated the sIRB Instructions to reference the ‘Onboarding’ tab

Coordinator, Email Notifications, FRL, May 2024, Relying HRPP, Study PI

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

April 2024, FRL, System Enhancements/ Bug Fixes
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.

Updated Feature: Modified Uploading Approval dialog

Approvals, FRL, March 2024

The Status section of the approval dialog has been modified – moved to the top of the dialog, color changed from grey to blue, is now required, and a new tooltip with the message, “Select Approved if you are ready to share the approval and Pending to save and return later.” This is to ensure that the Reviewing IRB and/or Study Manager marks the Status of the approval they are uploading since in the past it was often missed.

The Type of Study is also now editable at the review level when uploading a continuing review and study-wide amendment.

Bug Fixes – March 13, 2024

FRL, March 2024, System Enhancements/ Bug Fixes
Enhanced: Modified UI when indicating a study-wide amendment has a protocol change.
Fixed: Amendment # field removed from initial and continuing review approval dialog.
Fixed: Relying site notification about updated approval now displaying table of changes.
Fixed: Bug breaking ability to create a new site amendment.
Fixed: Reviewing IRBs and/or Study Managers cannot Request Agreements if IREx Setup and Primary Study Team Contacts incomplete, to prevent missing information on the notification.

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.