The columns on the Participating Site Report have been rearranged in the order we’d expect the dates to happen. Reviewing IRBs can access the Participating Site Report from their Reviewing Site’s Studies Dashboard.
Category Archives: FRL
Bug Fixes – January 4, 2024
| Enhanced: Envelope icon added on the ‘Agreements Complete’ button to signify user can request agreements. |
| Fixed: Removed the HTML code displayed on the SSRP when clicking site’s ‘Started’ status on the Status Summary tab. |
Updated Feature: SS Tab Export: Capture Date Requested Agreements
The “Request Agreement Date” is now in the Status Summary Tab Export. The export will list only the first/original date requested agreements for a site. The Reviewing IRB and IREx Study Manager can access the export from the Status Summary Tab.
Updated Feature: Allow to select multiple sponsors in the ‘Create a Study’ dialog
Reviewing IRBs can now select multiple sponsors when creating a new study.
If ‘other’ is selected, the Reviewing IRB will be required to enter the other sponsor’s name and add multiple other sponsors as needed.
Updated Feature: Sponsors now listed in the Overall Study Export
The Overall Study Export has a new ‘Sponsors’ column that lists the sponsors for a study. Multiple sponsors are separated by commas. Reviewing IRBs can access the Overall Study Report from their Reviewing Site’s Studies Dashboard from the Export menu.
Updated Feature: Modified Participating Site Report by rearranging columns
The columns on the Participating Site Report have been rearranged in the order we’d expect the dates to happen. Reviewing IRBs can access the Participating Site Report from their Reviewing Site’s Studies Dashboard.
Bug Fixes – December 12, 2023
| 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. |
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.