IREx released user-specific checklists (“Getting Started Checklists”) on each study to help IRBs and study teams navigate their reliance-related steps. The checklists are role-specific and auto-hide once all the steps have been completed for a given study.
View Getting Started Checklists here.
Enhanced: IREx now allows multiple draft documents to be uploaded during study creation. Drag and drop multiple documents or select all to upload simultaneously.
IREx launched a YouTube channel to host short system demonstration videos. You can also subscribe to our YouTube channel to stay in the know on new features.
Fixed: The Site Approvals window has been updated to highlight any tabs with missing information or errors for the Reviewing IRB or Study Manager. This should help reduce errors and premature approval notification emails.
The IREx approval notification will no longer attach approval documentation to the new approval notice email. Instead, each email will contain a link to the study page where all the appropriate documents are available. This ensures that all approval emails deliver on time and are not delayed due to file size. This is also an improved security measure to ensure that only current / active study team members have access to the documents.
Enhanced: IREx has added warning text and pop-up windows to all actions that trigger automatic email notifications to facilitate better communication from Reviewing IRBs to Participating Sites. These pop ups will identify who will be emailed and provide steps for what to do if you do not wish to send a notification immediately.
Enhanced: To help participating site HRPPs identify their local investigator / study team contacts, IREx now requires a Participating Site contact list document for studies where Participating Sites are listed. This document can be updated when new sites are added to the study.
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.
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.
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.
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.