Category Archives: FRL

Updated Feature: Agreement Dashboard located on the IREx Homepage.

Agreements/ Reliance, FRL, March 2021, Relying HRPP, Reviewing IRB

All HRPP Liaisons have access to the Agreement Dashboard from the IREx Homepage. This dashboard reflects all reliance and indemnification agreements for one’s site on three tabs where HRPPs can track (1) non-SMART reliance agreements one’s institution is offering when serving as the SIRB; (2) indemnification agreements their institution is using when serving as the SIRB; and (3) reliance and/or indemnification agreements their institution has or is expected to sign when relying on an SIRB for a study.

Bug Fixes – March 2, 2021

FRL, March 2021, System Enhancements/ Bug Fixes
Fixed: Liaisons and Study Managers are carbon copied (cc’d) on all site approval emails.
Fixed: Agreement checker reflects sites that have executed agreement with the named SIRB.
Fixed: Sites that have signed SMART IRB version 2 display “SMART 2” on the Status Summary tab.
Fixed: Multisite Liaisons do not see the Multisite Liaison Dashboard (“Your Sites” tab) when serving as the SIRB.
Fixed : All Lead Study Team contacts are carbon copied (cc’d) on all site approval emails.

New Feature: sIRBs Can Reset SSRPs

Agreements/ Reliance, FRL, Relying HRPP, Reviewing IRB, September 2020, Study-specific Reliance Plan (SSRP)

Single IRBs (sIRBs) now have the ability to reset and edit an accepted Study-Specific Reliance Plan (SSRP) for Relying Institutions. When this happens, the Relying Institution is notified of specific changes that were made and can log in to accept the revisions. Then, IREx sends an email, “Relying HRPP Accepted Revised SSRP,” to the sIRB and Relying Institution once the reset SSRP is accepted. Additionally, the date when the revised SSRP was accepted will be reflected on the Status Summary tab and export. (Of note: the sIRB also maintains the ability to edit the SSRP for a Relying Institution before it is accepted.)

As a reminder, the SSRP, used to document how the flexible elements of the SMART IRB Agreement will be implemented, is established when the sIRB creates a study in IREx. Relying Institutions indicate reliance on the sIRB by accepting the SSRP.

Enhanced Feature: Study Managers Can View SSRP Documents from Status Summary

Agreements/ Reliance, FRL, IREx Study Manager, September 2020, Status Summary Tab, Study-specific Reliance Plan (SSRP)

Study Managers can now use the Status Summary Tab, which provides an overview of sites’ progress completing the steps towards sIRB approval, to access Study-Specific Reliance Plan (SSRP) documents. Under the Reliance Decision column of the Status Summary, a site will have a green Completed status, which when clicked, will open the SSRP page. This page shows the SSRP survey responses agreed upon by the sIRB and site, a copy of the letter of reliance, and a PDF of the SSRP responses.

New Feature: Agreement Checker Available to All Users

August 2020, FRL, IREx Access, IREx Study Manager, Reviewing IRB

Our newest IREx Feature, the “Agreement Checker”, is a dynamic report page allowing you to list potential participating sites to see if they have signed the SMART IRB reliance agreement, joined IREx, and signed the sIRB’s Letter of Indemnification, if applicable. The list can also be exported into a comma-separated values (CSV) file. The Agreement Checker can be of particular help to sIRB’s who want to contact sites to complete agreements before a study is created in IREx, or for study managers gauging site readiness and preparing reliance instruction for sites (sample here). The “Agreement Checker” is located under the Resources section on the IREx homepage after logging into IREx.