Category Archives: FRL

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.

Updated Feature: Improved Getting Started Checklist for Study Managers Uploading Approvals

Approvals, FRL, Getting Started Checklists, IREx Study Manager, July 2020

As of March 2020, Study Managers can upload Continuing Reviews and Study-Wide Amendments on behalf of the sIRB. This month we improved their Getting Started Checklist to avoid some confusion. The steps “Upload Overall Study Approval” and “Publish Approval” disappear from the checklist once Study Managers have done these steps, so they know they are complete for that review and the next step is to upload approval for relying sites