When uploading the Initial study approval for a relying site, Reviewing IRBs and Study Managers will notice the “Is Site Enrolling?” question has been updated to, “Will Site Enroll Participants?”. This ensures Reviewing IRBs and Study Managers mark ‘Yes’ when uploading the initial approval for sites had not started enrollment. However, for Study-wide amendments and Continuing reviews, this question will remain the same.
Category Archives: IREx Study Manager
New Feature: Automating Local Considerations – Live Sept. 5, 2025
IREx now includes an automated local considerations feature that streamlines information collected in the HRP surveys by pre-populating the data from a site’s Institutional Profile, based on study elements identified by the Reviewing IRB. First, the Reviewing IRB selects applicable study elements (e.g., children, genetic testing) and can add up to five custom questions on the HRP and/or PI surveys. Then, IREx will pull the relevant questions related to the study elements from the IP into the HRP Survey. The HRP and PI surveys will have a new section, Study Elements Relevant to Local Review, with pre-populated information from their Institutional Profile (IP) that applies or custom questions, which the Relying HRPP can confirm or edit as needed.
New Feature: New ‘Confirm Study Elements’ step added to Checklist
A new ‘Confirm Study Elements’ step is added to the Reviewing IRB’s Checklist to capture study elements that apply to the study. The ‘Confirm Study Elements’ step is also added to the Study Manager Checklist when a Study-wide Amendment is created, allowing the Study Manager to make edits to the study elements as needed. Study elements include federally regulated and other elements related to state laws/local policies. Additionally, the Reviewing IRB and Study Manager can add up to five additional study elements/question(s) to the HRP and/or PI survey if “Other” is selected.
New Feature: Study elements history stored on Approvals tab
IREx will store the study elements history on the Approvals tab, next to the approval/review type. The study elements history can be used by anyone with study access to view which study elements were indicated and apply to the study per approval.
Enhanced Feature: Institutional Profile PDF removed from Local Considerations Export
The Institutional Profile (IP) PDF is no longer included in the local considerations export. This reduces duplicative review with information that may conflict on a per study basis now that relevant study elements, as indicated by the Reviewing IRB, is pre-populated from the IP into the HRP Surveys for revie
Updated Feature: Allow to turn off site amendment approval notifications
Reviewing IRBs and Study Managers now have an option to check a box to turn off the email approval notification and updates for site amendments.
New Feature: Reviewing IRBs can enable turning off approval notifications
To give more flexibility to Reviewing IRBs and Study Managers in their communication with study teams, IREx now allows for approval notifications to be turned OFF on a study-by-study, approval-by-approval basis. A new question in the IREx Setup, “Would you like to allow turning off study notifications?” lets Reviewing IRBs enable this feature and allow turning off IREx approval notifications and updates for the lead site/overall study and relying sites. Turning off notifications can be useful when making corrections (date correction, updated document) to an existing approval.
New Feature: Import contacts in IREx using Import Template
Reviewing IRBs and Study Managers can now import relying site study contacts into IREx in bulk. While this feature is available to use on any study, it may be best to use on studies with a large number of sites. For more information and instructions, view the Import Site Contacts Quick Guide.
Updated Feature: Display access status icon (checkmark) for each site in combo on Sites tab
Study Managers can now easily see which sites in a combo have access from their Sites tab, by looking for the status icon (checkmark) under the Grant Access column.
Updated Feature: Allow users to Replace Draft protocol documents until approval is published
When Reviewing HRPPs or Study Managers are uploading their approval documents, they must either ‘Accept’ the draft protocol or ‘Replace Draft.’ They can use the Replace Draft button to replace the protocol as many times as they need until the approval has been published. They still must ‘Accept’ the protocol before they can publish.