Fixed: To facilitate accurate documentation of sites engaged in research, IREx now allows FWA components to be listed on a study independently from their primary FWA holding institution. If a component and the FWA holder have separate study teams participating on the same study, both can be listed, provide separate cede decisions, and have approval documents provided independently.
Category Archives: FRL
System Enhancements – September 25, 2017
Enhanced: IREx allows IRB/ HRPP Liaisons to deactivate users at their institutions who no longer need access to IREx. To deactivate an account, search for the user on the Find Other Users page; click the user name to open the edit user window; change the user status to inactive; and click save.
Enhanced: IREx now attaches the Participating Study Team Quick Guide to all new study invitation emails sent to study teams. This quick guide outlines how Participating Site Study Teams can provide access for other study team members and how to access and download approval documents.
Enhanced: IREx now allows the Reviewing IRB Liaisons to update the protocol version name when replacing a draft protocol with a final approved version.
Bug Fixes: September 25, 2017
Fixed: Liaison and study team access to approval documents is now restricted to only documents associated with their institution. Multi-site Liaisons and Liaisons of FWA components can see and download documents for all the FWA institutions and components they manage.
Fixed: We updated the Participating Site approvals interface to carry forward sites that ceded review on a previous version, but have not yet been approved on the most current version. This enhances the version control to ensure the Participating Site initial review is associated with the correct version of the protocol.
New Feature: New Coordinating Center Staff Role
IREx has created a new user role called the coordinating center staff (CC Staff). This role is assigned by the Reviewing IRB Liaison. The CC Staff is typically the coordinating center contact or a member of the Lead Study Team who is responsible for managing Participating Sites in IREx.
CC Staff have the ability to add or remove sites to the study and upload approvals for Participating Sites as they are received. These users also have access to the Status Summary Tab to track Participating Sites through the reliance process until they are ready for sIRB review.
System Enhancements – July 7, 2017
Enhanced: A link to the IREx Terms of Use Portal Agreement is now available on the IREx login page.
New Feature: Multi-site Liaisons for users overseeing multiple FWAs
IREx supports institutions that oversee or provide HRPP functions for multiple FWAs using the Multi-Site Liaison feature. IRB/HRPP Liaisons can be set up as “Multi-Site Liaisons” to manage multiple FWAs with one user account. Multi-Site Liaisons can easily manage Institutional Profiles for each FWA, as well as indicate reliance and access approval documents each FWAs, even within a single study, in IREx. Contact the IREx team to be set up as a multi-site Liaison.
New Feature: Status Summary Tab
The Status Summary Tab provides an overview of status of all Participating Sites listed on a study. Use this tab to track each site’s progress towards sIRB review as they sign on to the required agreements to begin reliance and indicate reliance on the Reviewing IRB. This tab is available to the Reviewing IRB Liaisons and Lead Study Team Members.
System Enhancements – May 18, 2017
Enhanced: We have made major revisions to our IREx notifications to ensure they provide relevant information and details on next steps required in the reliance process.
Find and List FWA Component Sites on a Study
IREx supports affiliated institutions that are listed as component sites on an FWA. Components do not have separate accounts in IREx. Instead, their access is managed by the FWA holder’s Liaison(s) and share an Institutional Profile with the FWA-holding institution. IRB Liaisons can manage their FWA components using the components button on the IREx homepage. To list a component site on a study, the Reviewing IRB or Study Manager can search for components by name or FWA number using the Add a Site box in the Edit Participating Site window.
System Enhancements – March 3, 3017
Enhanced: Reviewing IRB Liaisons and IREx Study Managers can list individual Participating Sites on a study in IREx without creating a network or consortium.