Category Archives: FRL

New Feature: Participating Sites can View Status Summary

Coordinator, FRL, Getting Started Checklists, October 2019, Relying HRPP, Status Summary Tab, Study PI

Participating Site HRPPs and Study Teams now have a new tab “Status Summary” tab where they can visualize their site’s progress completing the steps towards sIRB approval. This tab is view only – no actions are completed on the tab. Participating Site HRPPs and PIs will continue to complete their steps on the Getting Started Checklist, which also has a navigation link to the Status Summary called “View Status Summary”. This feature is expected to bring transparency and clarity to participating sites as their HRPPs and study teams works towards reliance.

Updated Feature: Tracking Changes to the Local Considerations HRP Survey

Coordinator, Email Notifications, FRL, IREx Study Manager, Local Considerations, October 2019, Relying HRPP, Study PI

The Human Research Protections (HRP) Survey and PI Survey are key parts of capturing local considerations. When Participating Site HRPPs edit the PI or HRP Survey, an email notification is now sent to the Study Manager indicating what was changed on the survey. This feature is expected to help ensure Study Managers distinguish what was changed and ensure their requested changes were made appropriately.

Updated Feature: Modified Continuing Review Documentation for Studies Closed to Enrollment

Approvals, FRL, October 2019, Relying HRPP, Reviewing IRB

Although studies that are designated as Greater than Minimal Risk (GTMR) require consent forms, IREx now allows for the input of GTRM Continuing Reviews that are reviewed via the expedited review process. A consent form is no longer a required document for these reviews to better facilitate, for example, studies that are closed to enrollment. This change helps accommodate nuances of different phases of study conduct.

Updated Feature: Amendment Notifications Now Include Change Summary

Approvals, Email Notifications, FRL, IREx Study Manager, October 2019, Reviewing IRB

Study-wide and site-specific amendment email notifications have been updated to include the protocol version number (as entered by the Reviewing IRB), the automatically assigned “Revision #” when a study-wide amendment does not change the protocol, and the change summary for the amendment. That now means sIRBs and Study Managers are required to provide a description of changes when uploading site-specific amendments, as is already required for study-wide amendments. IREx recommends starting the change summary with the amendment number to help the site identify the change. This information is then embedded in the notification email to help sites and sIRBs communicate more clearly about amendments.

Updated Feature: Enhanced Study-wide and Site Amendment Email Notifications

Approvals, August 2019, Email Notifications, FRL, IREx Study Manager, Reviewing IRB

To provide more information about amendment approvals uploaded to IREx, the study-wide and site-specific amendment approval notifications will now include the study protocol version number and the change summary, both of which are entered by the Reviewing IRB. TIPS:

  • Minimize confusion for the study teams by ensuring the “protocol version” matches the version that is listed on the protocol.
  • Increase consistency by including the amendment # from your IRB system at the beginning of the change summary.

Additionally, when uploading site-specific amendments, sIRB Liaisons or Study Managers will now be required to provide a description of the changes. TIP: We recommend starting the change summary with the amendment # to help the site identify the change.