Category Archives: FRL

New Feature: Capture Study-Specific Local Context from Participating Sites

February 2018, FRL, Local Considerations, Relying HRPP, Reviewing IRB

IREx released a local context/local considerations module to allow Reviewing IRBs to centrally capture study-specific local considerations for each site, using standardized surveys and questions aligned with national sIRB initiatives.

The local considerations module has two surveys: 1) The Human Research Protections (HRP) survey asks about requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local site ancillary reviews, relevant to the specific study or trial that would affect the conduct or approval of the research at your institution, as well as the consent form for this study. This is completed by the Participating Site HRPP Liaison; and 2) the PI survey asks about the conduct of the study at your site and is completed by the Participating Site PI. The Participating Site HRPP must verify the PI survey responses.

New Feature: Access your Approval Documents Directly in IREx

Approvals, Coordinator, FRL, November 2017, Study PI

The IREx approval notification will no longer attach approval documentation to the new approval notice email. Instead, each email will contain a link to the study page where all the appropriate documents are available. This ensures that all approval emails deliver on time and are not delayed due to file size. This is also an improved security measure to ensure that only current / active study team members have access to the documents.

System Enhancements – November 13, 2017

FRL, November 2017, System Enhancements/ Bug Fixes

Enhanced: IREx has added warning text and pop-up windows to all actions that trigger automatic email notifications to facilitate better communication from Reviewing IRBs to Participating Sites. These pop ups will identify who will be emailed and provide steps for what to do if you do not wish to send a notification immediately.

Enhanced: To help participating site HRPPs identify their local investigator / study team contacts, IREx now requires a Participating Site contact list document for studies where Participating Sites are listed. This document can be updated when new sites are added to the study.

Bug Fixes – November 13, 2017

FRL, November 2017, System Enhancements/ Bug Fixes

Fixed: To facilitate accurate documentation of sites engaged in research, IREx now allows FWA components to be listed on a study independently from their primary FWA holding institution. If a component and the FWA holder have separate study teams participating on the same study, both can be listed, provide separate cede decisions, and have approval documents provided independently.

System Enhancements – September 25, 2017

FRL, September 2017, System Enhancements/ Bug Fixes

Enhanced: IREx allows IRB/ HRPP Liaisons to deactivate users at their institutions who no longer need access to IREx. To deactivate an account, search for the user on the Find Other Users page; click the user name to open the edit user window; change the user status to inactive; and click save.

Enhanced: IREx now attaches the Participating Study Team Quick Guide to all new study invitation emails sent to study teams. This quick guide outlines how Participating Site Study Teams can provide access for other study team members and how to access and download approval documents.

Enhanced: IREx now allows the Reviewing IRB Liaisons to update the protocol version name when replacing a draft protocol with a final approved version.

Bug Fixes: September 25, 2017

FRL, September 2017, System Enhancements/ Bug Fixes

Fixed: Liaison and study team access to approval documents is now restricted to only documents associated with their institution. Multi-site Liaisons and Liaisons of FWA components can see and download documents for all the FWA institutions and components they manage.

Fixed: We updated the Participating Site approvals interface to carry forward sites that ceded review on a previous version, but have not yet been approved on the most current version. This enhances the version control to ensure the Participating Site initial review is associated with the correct version of the protocol.