sIRB liaisons receiving notifications for a study will receive an email notification when the study manager has published any study-wide approval (e.g., Continuing reviews and study-wide amendments) in IREx. The subject line of this notification reads “FYI: Overall Approval Uploaded to IREx”. Study managers are also copied on this email. The email will list the type of approval and provide a link to the study. No action steps are associated with this notification.
Category Archives: FRL
Updated Feature: The ‘Track Site Progress on Status Summary’ step on the Study Manager checklist has been renamed
The ‘Track Site Progress on Status Summary’ step on the study managers’ Getting Started Checklist has been renamed to ‘View Site Progress on Status Summary’. This step is available once a site has been added to the study.
Updated Feature: Removed ‘Add PI Info’ step on the Study Managers’ Getting Started Checklist
The ‘Add PI Info’ step has been removed from the study managers’ Getting Started Checklist to help streamline other actionable steps. The sIRB liaison and study manager can add PI information from the Edit Participating Site dialog when listing a site and from the Status Summary tab before notifying the sites’ access to the study.
Updated Feature: The ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will now appear at the top of the Study Manager checklist
To help study managers prioritize their actions, the ‘Upload Overall Study Approval’ and ‘Publish Approval’ steps will not appear at the top of the Study Managers’ Getting Started Checklist when an initial approval, continuing review, or study-wide amendment is in progress. These steps disappear after the overall approval is published.
Bug Fixes – September 6, 2022
| Fixed: Accurately display Combo Sites on Add/Edit Participating Sites dialog. |
| Enhanced: The Reviewing IRB and Study Manager will see an alert when a study-wide amendment change summary character count exceeds 3999 characters. |
| Fixed: PI Survey Attestation date on Status Summary Export accurately matches PI Survey Attestation date on Status Summary Tab. |
| Fixed: PI(s) are listed on Relying HRPP Dashboard before HRPP registers for study. |
| Fixed: Study Manager Dashboard now shows the number of sites on the study after sites are added. |
Bug Fixes – June 7, 2022
| Fixed: Show all IREx sites in ‘Select a site’ dropdown menu when adding a Study Manager(s) from the Study Team Contacts dialog. |
| Fixed: No longer showing component sites in ‘Select a site’ dropdown menu. |
| Fixed: Only show IREx member sites in ‘Select a site’ dropdown menu. |
| Fixed: Allow participating sites to register for study when part of a combo site. |
| Fixed: Edit Participating Site dialog to load sites listed on study and search bar to add sites. |
| Fixed: Display site names on Edit Participating Site dialog instead of FWA number. |
| Fixed: Allow saving existing Study Manager as a Coordinator on another study. |
| Fixed: Allow Relying HRPPs to add an additional engaged site (create combo site) on the registration page. |
| Fixed: User creation dialog to validate email address. |
New Feature: SIRBs and Study Managers can Resend Study Notification to Sites
The sIRB and Study Manager can now re-notify/contact a site about a study by resending the “IREx study at your site” notification. This is done by clicking the site’s ‘Contacted’ status from the Status Summary tab. The subject line of the email notification will include the sender’s name who is re-contacting the site (e.g., “Jane Smith is resending your IREx Study Notification”). This feature is used to follow up with sites that have not yet started on the study.
Updated Feature: The Manage Version, site amendment pop-up has been updated
On the Study-wide IRB Approvals tab for sIRBs and Study Manager, the “+Add Site Amendment” button on the Manage Version tab has been updated to include pop-up text directing users, “To add a SITE amendment click on the Approval History tab”. This is to reflect the changes where sIRBs and Study Managers can add site amendments from the Approval History tab.
Updated Feature: Protocol document not included in the sort filter
On both the Study-wide IRB Approvals and the Approval History tab, the protocol is now pinned at the top of documents and not included if sorted. This is to help make it easier for users to find the protocol after sorting.
Updated Feature: The Manage Version, site amendment pop-up has been updated
On the Study-wide IRB Approvals tab for sIRBs and Study Manager, the “+Add Site Amendment” button on the Manage Version tab has been updated to include pop-up text directing users, “To add a SITE amendment click on the Approval History tab”. This is to reflect the changes where sIRBs and Study Managers can add site amendments from the Approval History tab.