Category Archives: Reviewing IRB

Updated Feature: Renamed Tabs

You will notice some rewording of the study page tabs. The first, blue tab is now titled Study-wide IRB Approvals (before called “Reviewing IRB Approvals”) because these documents are relevant to all sites. The second, orange tab is now titled Site-specific IRB Approvals (before called “Relying Site Approvals”) because it captures documents for each site. Both tabs retain the same functions as before but are more appropriately named.

Updated Feature: Protocol Version

When creating a study or adding an amendment, a version name is required for the protocol. The “Protocol Version” field has been relabeled as “Protocol Date and/or Version” to clarify that users should enter the version number as entered on the protocol, which is often a date. In IREx trainings, users have also been encouraged to enter the amendment number in the summary of changes so that it is reflected on IREx and on email notifications sent out when changes are made.

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

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

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

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

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.

New Feature: Capture Site-specific Comments

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

New Feature: Indicate “No Further Review Required” for Qualifying Studies

In line with the revised Common Rule, IREx now allows sIRBs to indicate “No Further Review Required” and NOT enter an expiration date for studies that no longer require continuing review (more here). For studies where this feature is used, sites will no longer have an expiration date listed in IREx and the IREx approval notifications will direct site investigators to refer to the approval letter from the sIRB and their local HRPP for ongoing reporting requirements.