Study Managers can now easily see which sites in a combo have access from their Sites tab, by looking for the status icon (checkmark) under the Grant Access column.
Category Archives: FRL
Updated Feature: Allow users to Replace Draft protocol documents until approval is published
When Reviewing HRPPs or Study Managers are uploading their approval documents, they must either ‘Accept’ the draft protocol or ‘Replace Draft.’ They can use the Replace Draft button to replace the protocol as many times as they need until the approval has been published. They still must ‘Accept’ the protocol before they can publish.
Bug Fixes – March 3, 2025
| Fixed: “IREx: Participating Sites Removed from Study” notification is sending again. |
| Fixed: “IREx: Participating Sites Added to Study” notification is sending again |
| Fixed: Display study contacts on Sites and Contacts page for all sites in combo if combo is linked via PI email. |
Updated Feature: Managing Combo Sites
Reviewing IRBs and Study Managers can now easily modify their sites that engage multiple FWAs, known as Combo Sites in IREx. On the Sites tab, deleting a Combo Site will now display the Manage Combo Sites dialog, which allows you to select sites you want to delete and/or add a site by using the +Add Site button.
Bug Fixes – January 6, 2025
| Fixed: Liaisons added back to Participating Institutions page |
| Fixed: Display the Approval History tab for Multisite Liaisons after receiving CCP Acceptance on an EFIC study |
| Fixed: Display the Approval History tab for combo sites when their status is CCP Accepted on an EFIC study. |
| Fixed: Relying HRPPs cannot add the sIRB and existing sites as additional engaged sites on the registration page. |
Bug Fixes – December 2, 2024
| Enhanced: Add API documentation for sites endpoint, site ID disambiguation, and optional submission ID for initial relying site approvals. |
| Enhanced: Cache CSV export of all sites’ IP. |
| Enhanced: Cache public Participating Institutions site list. |
| Fixed: Non-primary liaisons to notify are included on ‘Reviewing IRB uploaded new approval for Lead Site’ notification. |
Updated Feature: New question included on Institutional Profile (IP) Exports
The new IP question, “Do you have local instructions for investigators when relying on another IRB?” will now be included on the IP CSV download.
Updated Feature: Modified text on IREx Setup
On the IREx Setup, Review & Submit tab, text modified from…
- “The reviewing IRB is NOT participating in the study” to “The reviewing IRB is NOT the lead site” if the sIRB selected ‘No’ to the question, “Is the Lead Site also at the Reviewing IRB Institution?”
- “Local context collected by CIRB” to “Local context collected by sIRB” if selected, ‘Sites will provide consents for sIRB review (e.g., using a template) OR study will not have consents.’ to the question “How are sites’ consent forms being handled?”
Bug Fixes – November 4, 2024
| Enhanced: Type of Study (GMR or MR) now included on the Lead Site approval notification. |
| Fixed: List sIRB as ‘Admin Only’ participating site if lead site is different. |
| Fixed: Key Dates validation on lead site approval dialog. |
| Fixed: The IP ‘Updated’ date on the Participating Institutions page does not change if the IP was not modified (but confirmed for a study). |
| Fixed: Global Documents will not display Consultation Plan Template if not uploaded. |
| Fixed: Updated approval notification no longer sending if Date Reviewed did not change. |
New Feature: The Institutional Profile (IP) now available for CSV download
The Institutional Profile (IP) is available to export as CSV format both on the public website “Participating Institutions” page and within the IREx portal on the “Find Other Site” page. To download a CSV file of ALL responses from ALL IREx Participating Institutions, click Export Institutional Profiles (IP) and either Export IP Labels (all questions and answers written out as they appear on the IP) or Export IP Raw (variable names and raw data). Users can also download a CSV file of IP responses from one specific institution by clicking CSV button next to that institution’s name.