In line with the revised Common Rule, IREx now allows sIRBs to indicate “No Further Review Required” and NOT enter an expiration date for studies that no longer require continuing review (more here). For studies where this feature is used, sites will no longer have an expiration date listed in IREx and the IREx approval notifications will direct site investigators to refer to the approval letter from the sIRB and their local HRPP for ongoing reporting requirements.
Category Archives: IREx Study Setup
System Enhancements – February 18, 2019
Enhanced: We have added help text in the IREx Project Settings window for Reviewing IRB liaisons to explain why Reviewing IRB liaisons cannot be listed as IREx Study Managers. As a reminder, liaisons already have IREx Study Manager privileges for all studies at their institution and do not need to be designated for each study.
New Feature: Streamlined Study Setup and Notification Preferences
IREx has streamlined how studies are created by Reviewing IRBs. Now Reviewing IRBs can quickly create a study with only four pieces of information: the study title, the sponsor name and a draft protocol and protocol version number.
Reviewing IRBs can also now indicate which of their Liaisons is the “Primary Liaison” for a given study. Other site Liaisons can receive notifications or opt out of all notifications for the study. However, all Liaisons will still have access to the study in IREx, and the Primary Liaison and email preferences can be updated at any time.
Add draft documents on study creation
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.
sIRBs that are not participating research sites on a study
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.