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.
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.
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.
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.
Enhanced: Reviewing IRB Liaisons and IREx Study Managers can list individual Participating Sites on a study in IREx without creating a network or consortium.
IREx sends an official documentation of reliance email to the Reviewing IRB Liaisons, Participating Site HRPP Liaisons and Study Team Members.
This email is sent after the Participating Site HRPP Liaison has accepted the Reviewing IRB’s study-specific reliance plan (SSRP). A PDF of the letter of reliance is attached to this email.
IREx allows Reviewing IRB Liaisons to upload draft documents such as draft protocols and informed consent documents during study creation. These documents are visible on the Reviewing IRB approvals tab to all Participating Sites and are labeled as drafts. Users receive a pop-up warning before they download the documents letting them know that the documents have not yet been approved by the sIRB.
IREx has been updated to support scenarios where the Reviewing IRB institution is not a participating research site or is not the lead site for a given study. During study creation, the sIRB can now indicate whether or not they are a participating site.
Reviewing IRB Liaisons can use the Add a Site button on the Edit Participating Sites window to list additional sites on their studies in IREx. Reviewing IRB Liaisons can also type in the institution name if they are not already listed in IREx and the IREx team will add the institution as a site to IREx (note: the site must still be onboarded to get access to IREx).
