Category Archives: FRL

System Enhancements – April 2, 2019

Enhanced: IRB liaisons can click the components button to see which studies their FWA components are listed on. As a reminder, liaisons can add and remove FWA components at any time as long as they are not listed on an existing study.
Enhanced: We have improved our user interface to speed up the study page load time for larger studies with several participating sites.

New Feature: New IREx Study Manager Dashboard

IREx Study Managers have a new Study Manager Dashboard that gives an at-a-glance summary of their studies in IREx. For each study, the dashboard shows Study Managers how many participating sites have 1) registered, 2) completed each of the required agreements, 3) indicated reliance, 4) completed all local considerations (if applicable), and 5) received approval for the current version. The dashboard is color-coded, and each counter will turn green when all the participating sites listed on the study have completed that step.

System Enhancements – March 26, 2019

Enhanced: We have added a new Complete Agreements step to the Relying HRPP Getting Started Checklist that will show what agreements are required to rely on the Reviewing IRB for the study. Relying HRPP Liaisons will need to complete the required agreements before they can indicate reliance for a study.
Enhanced: We have added clarification text to the Complete IREx Setup window to clarify which local considerations module to use when a study does not require consent forms.

New Feature: Introducing Indemnification Tracking in IREx

IREx now supports Letter of Indemnification (LOI) Tracking. The LOI is a unique agreement between the Reviewing IRB and participating institutions concerning indemnification and related terms, if required, when using the SMART IRB Agreement. Both Reviewing IRBs and Participating Sites can use IREx to easily track the status of their LOI agreements. Reviewing IRBs can track which institutions have signed their LOI and, if they choose to, store the executed agreements in IREx. Participating Sites can view which LOIs they have signed for other institutions.

Bug Fixes – December 10, 2018

Fixed: We have added help text in Edit Participating Site window for Study Managers and Reviewing IRBs to explain how PIs and coordinators get access to IREx. As a reminder, Participating Site Study Teams get access from their local HRPP, after their HRPP has accessed the study
Fixed: We have updated IREx to default all initial protocol documents as draft documents until the Reviewing IRB is ready to publish their approval.
Fixed: Based on a suggestion from our User Feedback Group, we have added a newsletter archive to our website with links to and short descriptions of past IREx newsletters.