Category Archives: Approvals

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.

Updated Feature: Modified amendment approval email notification

Approvals, Email Notifications, February 2024, FRL, Local Considerations

The amendment approval notification sent to relying sites has been modified for studies capturing local consideration updates for the life of a study. The email subject changed from, “IREx: New IRB Approval For Your Site.” to “ATTN: Approved changes may require local review.” A new Amendment Content section outlines the type of changes and a link on how to edit the surveys is also included.

New Feature: Streamline Sharing and Notifying Relying Sites of new Continuing Review and Study-wide Amendment Approvals

Approvals, FRL, IREx Study Manager, October 2022, Reviewing IRB

Relying site approvals no longer have to be individually confirmed after publishing a continuing review or study-wide amendment. Now, if relying sites did not have site-specific changes, their approvals can be confirmed when adding the overall approval so that sites automatically get notified of the Continuing Review or Study-wide Amendment when the overall approval is published.

New Feature: Lead site consents will carry forward on Continuing Reviews if they did not change

Approvals, FRL, October 2022, Reviewing IRB

Previously, IREx required new consent forms to be uploaded at the time of continuing review. However, when sIRBs do not re-stamp consents at the time of continuing review, a new consent is not approved and therefore a new version should not be uploaded. Now, sIRBs and Study Managers can indicate that the consent(s) was not changed and carryforward the currently approved consent form.

New Feature: When posting the lead site/overall approval, sIRBs and Study Managers can indicate whether approved sites had site-specific changes at Continuing Review and for Study-wide Amendments on “Site Updates” tab

Approvals, FRL, IREx Study Manager, October 2022, Reviewing IRB

A new tab – “Site Updates” – has been added when uploading continuing reviews and study-wide amendments. This new tab captures whether any approved sites had site-specific changes as part of the new approval (e.g., updated or newly stamped consent forms). Any enrolling sites that did not have changes are automatically marked as ‘approved’ and notified when the overall / lead site approval is published. The approval for sites with changes must be uploaded after publishing the lead overall / lead site approval.