Category Archives: FRL

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.

Updated Feature: Status Summary Export Now Includes Dates of sIRB Submission, Review and Approval, if available

FRL, IREx Study Manager, July 2019, Reviewing IRB, Status Summary Tab

Two new fields were added to the Status Summary Export – “Date Submitted” to the sIRB and “Date Reviewed” by the sIRB. The Export already includes “Date Approved” by the sIRB. These additional fields can be used by Study Managers as a flag/reminder that a site has been submitted for review to the sIRB. The sIRB or SM can enter dates of sIRB submission and review in the “site approvals” dialogue.

Updated Feature: Local Considerations Complete Notification Now Includes Outstanding Steps

FRL, Getting Started Checklists, July 2019, Local Considerations, Relying HRPP

In May we added “Complete Agreements” to the Relying HRPP Getting Started checklist. This feature allows sites to document and complete local considerations while their legal counsel is reviewing and executing any outstanding agreements, if needed. Sites are not allowed to document reliance or cede review until the agreements are complete, but, if a site completes local considerations before their agreements are complete, we now include in the email any outstanding steps that should be completed before the site is submitted to the sIRB for review, such as “Complete Agreements” or “Cede Review”.

Bug Fixes – July 29, 2019

FRL, July 2019, System Enhancements/ Bug Fixes
Fixed: IREx “Users” can now view studies where a component of their FWA is participating.
Fixed: The “Resources” link in the Study Manager welcome email was updated.
Fixed: The Local Considerations export now labels the component site folder using the FWA “short name” and the component site “short name” (e.g., North Univ Med Ctr– North Childrens Hosp”).

New Feature: Capture Site-specific Comments

FRL, IREx Study Manager, June 2019, Reviewing IRB, Status Summary Tab

Reviewing IRB Liaisons and Study Managers can now include site-specific comments on the Status Summary tab in IREx. Comments are only visible to the Reviewing IRB Liaisons and Study Managers on a study. No notifications are generated by these comments. Any information that helps keep track of site’s progress can be logged, such as:

  • the last time you contacted a site
  • when you sent reliance instructions
  • unique workflow challenges or alternatives for a site
  • status updates from a PI or a site’s HRPP
  • reason a site’s local review might be delayed