Category Archives: June 2019

New Feature: Capture Site-specific Comments

FRL, IREx Study Manager, June 2019, Reviewing IRB, Status Summary Tab

Reviewing IRB Liaisons and Study Managers can now include site-specific comments on the Status Summary tab in IREx. Comments are only visible to the Reviewing IRB Liaisons and Study Managers on a study. No notifications are generated by these comments. Any information that helps keep track of site’s progress can be logged, such as:

  • the last time you contacted a site
  • when you sent reliance instructions
  • unique workflow challenges or alternatives for a site
  • status updates from a PI or a site’s HRPP
  • reason a site’s local review might be delayed

New Feature: Indicate “No Further Review Required” for Qualifying Studies

FRL, IREx Study Setup, June 2019, Reviewing IRB

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.

Bug Fixes – June 28, 2019

FRL, June 2019, System Enhancements/ Bug Fixes
Fixed: IREx behaved erratically when users accessed it via Internet Explorer (IE), so the platform was updated to more compatible with IE.
Fixed: When uploading a relying site’s approvals, dates of submission, review and approval are required. IREx was requiring the dates, but not telling Study Managers which sites were missing dates.