IREx updated the email sent to Reviewing IRBs, “IREx: Participating Sites Added to Study” when a Study Manager adds site(s) to a study that previously offered the SMART IRB V1/V2 reliance agreement. The email subject changed to “IREx: Action Required – Add Reliance Agreement.” This is to notify Reviewing IRBs they must log in to IREx and indicate another reliance agreement (e.g., SMART IRB V3.0) from the IREx Study Setup, since sites can no longer rely using the SMART IRB Agreement V1/V2 after March 17, 2025. This will allow the newly added sites to move forward and complete reliance.
Category Archives: December 2025
Updated Feature: Modified “Is Site Enrolling” question on Relying Site Approvals dialog for Initial Approvals
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.
Bug Fixes – December 1, 2025
| Fixed: No longer sending the “IREx Access and Single IRB Instructions” email to the lead study PI. |
| Fixed: Updated resource links on “IREx Access and Single IRB Instructions” email. |
| Enhanced: Include funding/sponsor on “IREx Access and Single IRB Instructions” and “Action Required: Please Complete Agreement(s) for sIRB study” email notifications |