Category Archives: FRL

System Enhancements – March 14, 2018

Enhanced: Links to the IREx Resources page and to the IREx trainings sign up are now available under the resources section of the home page. As always, the link to the Resources page is also available on the top right of every page in IREx. 

Enhanced: For study-wide amendments and continuing reviews, the Reviewing IRB review dates for the lead site / overall study are copied over to Participating Sites approvals to expedite the upload process.

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

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

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

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.