In the Participating Site Export, the column header, “dateInitialReviewApproved” is renamed to “dateLeadSiteInitialApproval” to help differentiate the date of initial approval for the Lead Site from relying sites.
Category Archives: FRL
Updated Feature: The Status Summary tab export now captures all dates sites were contacted
The Study Summary tab export will now include all dates a site was contacted. This export feature is only available to the Reviewing IRB and Study Manager(s) of a study.
New Feature: SIRBs and Study Managers can Add Site Coordinator Access to IREx
IREx now allows sIRBs and Study Managers to give coordinator access at sites that have registered for their study. For convenience, sIRBS and Study Managers can give coordinators access from:
- the Approval History tab, select the site from the View As dropdown and select +Add Site Coordinator Access from the site menu.
- the Participating Personnel dialog, select the +Grant Site Coordinator Access.
View this Add Site Coordinator Access Quick Guide for reference.
New Feature: SIRBs and Study Managers can give a new Site PI Access to IREx when adding a Site Amendment
If a site PI is changed after the site receives initial approval, sIRBs and Study Managers can give the new PI study access via a site amendment. This avoids asking the relying HRPP to login to IREx and add the new PI.
View this Add Site Amendment Quick Guide for reference.
New Feature: An email notification is sent to the PI when a new coordinator is added at their site.
When a sIRB or Study Manager gives a site coordinator access to their study, an email notification, “New Coordinator Added” is sent to the PI. The email lists the study title, the sIRB Liaison or Study Manager who added the coordinator, site name, new coordinator name and email, and link to the study.
Updated Feature: FWA short name is displayed on the Approval History tab when component sites are listed on a study
For clarity, a site’s FWA short name and full component site name will show in the ‘View As’ menu of the Approval History tab for sIRBs, Study Managers, and HRPPs overseeing multiple FWAs on a study.
Bug Fixes – April 4, 2022
| Fixed: Reinstated document filters on the Study-wide IRB Approval tab |
| Fixed: Allow study contacts to view approvals for all sites if listed as part of a combo site. |
| Fixed: Overall study Initial Approvals dialog now displays calendar on Key Dates tab. |
| Fixed: IRB Approval Documentation again shows as ‘Required’ on Relying Site Approvals dialog if an existing file is removed. |
| Fixed: Consents & Assents document type again show as ‘Required’ on the Site Amendment dialog if an existing file is removed. |
| Fixed: IREx Study Setup includes appropriate Indemnification options when selected for a study. |
New Feature: Reorganized Site Approvals on the NEW ‘Approval History’ tab
Relying Sites can now access ALL approval documents from a single tab. IREx has combined the Study-wide and Site-specific IRB Approvals tabs for relying sites into a single ‘Approval History’ tab to simplify navigation. On the Approval History tab, the current approval is displayed first followed by all past approvals in descending order. The Reviewing IRB and Study Manager can use the Approval History tab to view approvals shared with a specific site.
New Feature: Filter on the Approval History tab
The filter option on the Approval History tab allows users to filter approvals by review type such as, Amendments and Continuing Reviews. The filters help users easily find an approval shared by the sIRB.
New Feature: Capture Amendment number for Study-wide and Site-specific Amendments
The Reviewing IRB and Study Manager can now enter an Amendment number and description when uploading approvals for study wide amendments and site-specific amendments. The Amendment number is an optional field used to help study teams identify specific amendments.