On the Status Summary Tab, the “Not Approved” status is now hidden until the site completes all steps needed for sIRB review. These steps include the completion of agreements, reliance decision, and local considerations if applicable for the study. This is to ensure a site has completed all necessary steps before site approval is uploaded.
Category Archives: 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.
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.
New Feature: Grant Relying Site Study Teams Immediate IREx Access
IREx now automatically grants the relying site study teams access to the platform when their site is notified of a study. Study team contacts receive login credentials and can log in immediately to view study details, access the sIRB initial approval documents, and collaborate with the lead study team. Study teams no longer have to wait for their Human Research Protection Program (HRPP) administrators to log in and confirm access – minimizing unnecessary waiting periods. However, the relying HRPP must confirm study participation before the study team can complete the PI Survey.
Reviewing IRBs and Lead Study Teams (“IREx Study Managers”) can use the Status Summary page in IREx to notify sites and grant study teams access to the study.
Updated Feature: Introducing the Refreshed IREx Study Page with Streamlined Navigation
The IREx Study Page has a new look! All users will see the study title is now at the top of the study page, an info icon that contains study information and primary contacts, and a top navigation bar that provides quick access to frequently accessed pages.
The navigation bar includes easily accessible pages:
- Approvals Page: Stay on top of your study’s approvals with just a click! Effortlessly view and manage all the approvals associated with your study in one centralized location.
- Status Summary Page: Monitor the status of your study at a glance! The Status Summary page provides a comprehensive overview of your study’s progress, helping you track milestones and stay organized.
- Sites Page: [Reviewing IRB & Study Manager only] Access the Sites page directly from the top navigation bar to easily manage your sites; add/edit sites and include study team contact information for each site.
- Contacts Page: [Reviewing IRB & Study Manager only] Stay connected with key study personnel! Access the Contacts page to view study team contacts who have access to the study.
Updated Feature: The Status Summary tab now shows PI Attestation date
The local considerations section on the Status Summary tab now shows when the PI Survey is “Awaiting PI Attestation” and the PI Attested date.
Updated Feature: PI Survey Attestation Date available on Status Summary tab Export
The Status Summary Tab Export now includes the most recent PI Survey attestation date. All PI Surveys that were completed before Investigator Attestation was required will show the PI Survey completed date as the Investigator Attestation date.
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 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.
Updated Feature: Add descriptive text in Comment Bubbles for Sites
To clarify the Comment bubble function on the Status Summary tab, the button “Post” is now changed to “Save” when saving a comment. Descriptive text is also added in the Comment bubble dialog:
“Log and share internal notes with the Reviewing IRB Liaisons and Study Managers. No notifications are sent when a comment is posted.”