| Enhanced: Envelope icon added on the ‘Agreements Complete’ button if site agreements are incomplete – to signify user can request agreements. |
| Enhanced: Removed the ‘Site Approvals’ banner from the study-wide IRB approvals tab. |
| Enhanced: Updated template agreement status from ‘Complete’ to ‘Completed.’ |
| Fixed: Add Sponsors management dialog for admins. |
| Fixed: Additional engaged sites added on the study registration page will receive the new “IREx Access and Single IRB Instructions” email. |
| Fixed: Hide the Reviewing IRB’s checklist if sites have completed all agreements. |
| Fixed: Prevent API from allowing a second initial approval push. |
| Fixed: Permissions for adding an industry sponsor on the project dialog. |
| Fixed: Disabled ‘Contacted’ button on Status Summary tab if no PI entered. |
| Fixed: Added missing view-only banner on Coordinator’s Status Summary tab. |
| Fixed: Granted Access sort on Sites tab. |
| Fixed: Harmonize language on the ‘Agreement Instructions’ tab on the IREx Setup. |
| Fixed: Remove deleted sites from IREx from the Participating Institutions page. |
Category Archives: FRL
New Feature: Coordinator is renamed to “Study Team Member”
The “Coordinator” role has been expanded to be more inclusive of all study personnel (e.g., Regulatory Specialists, Research Nurse, Clinical Research Manager or Navigator, etc.). Coordinators will now have the title, “Study Team Member.” This role is intended for anyone on the study team other than an investigator. The permissions and workflow for this role have not changed.
New Feature: New steps added to the Reviewing IRB Getting Started Checklist
Reviewing IRBs now have a ‘Request Agreements’ step on their Getting Started Checklist when selecting ‘sIRB only’ in the study setup for whom can use IREx to send instructions for executing the required agreements. Reviewing IRBs will also have a new ‘Manage Agreements’ step on their checklist if there are sites with incomplete agreements listed on the study – when clicked, the Manage Agreements dialog will open for the Reviewing IRB to enter executed agreements for relying sites.
New Feature: Allow to resend ‘Request Agreements’ notification
Reviewing IRBs and Study Managers can resend the Request Agreements notification to sites with incomplete agreements. From the Status Summary’s Agreement column, use the drop down and press ‘Request Agreements’ to resend a notification. The button and pop-up will show the last date the request agreement notification was sent for the site.
Updated Feature: Allow to add contacts from the Contacts page
Reviewing IRBs and Study Managers can now use the ‘Edit Study Team Access’ button on the Contacts page to give access to additional contacts at sites with study access.
Updated Feature: Updated Reviewing IRB Getting Started Checklist
Reviewing IRBs now have a ‘Create Study’ step on their Getting Started Checklist. Clicking the step opens the ‘Edit Study’ dialog that allows the Reviewing IRB to make changes to the study title, short title, study summary, NCT#, and sponsor information.
Updated Feature: Updated Study Manager Getting Started Checklist
The IREx Study Manager’s Getting Started Checklist has a new ‘Request Agreements’ step. This step lets the Study Manager know they can send a notification to request sites’ complete the required study agreements. Also, the ‘Grant Site Access’ step now displays a pop-up with helpful information on granting sites access.
Updated Feature: Updated Study Team Getting Started Checklist
Relying site study teams now have a ‘Awaiting Reviewing IRB Approval’ step on their Getting Started Checklist. This step was added to let the PI and Coordinator know that after completing their steps in IREx, the next step is waiting for the sIRB to approve their site.
Updated Feature: Renamed ‘Add Site Coordinator Access’ from the Approval History tab
The ‘Add Site Coordinator Access’ menu option on the Approval History tab, has been renamed to ‘Add Study Team Access’. The Reviewing IRB and Study Managers can now give additional or new PIs access to the study using the ‘Add Study Team Access’ dialog at any time. Previously, they were only able to give coordinators access.
Bug Fixes – November 7, 2023
| Enhanced: On the Sites page, the ‘+Add Study Team Member’ button will appear under the Study Team Member column if none is listed. |
| Enhanced: Edit review and Edit Study Info buttons will be hidden on the study page until initial approval is published. |
| Fixed: Search bar now available on the Status Summary tab for Reviewing IRBs and Study Managers. |
| Fixed: Primary study contacts dialog layout can now display long email addresses without hiding the ‘x’ delete button. |
| Fixed: Relying site Liaisons and study team members can now delete study contacts. |