After local considerations are completed, additional information or clarifications may be necessary from relying sites. IREx has always notified the sIRB and Study Manager when Local Considerations are updated. Now, this notification will include a detailed table outlining the changes that were made to each survey.
Category Archives: Reviewing IRB
Updated Feature: Updates to Status Summary Export
IREx helps manage Letters of Indemnification (LOIs) for institutions that require them when serving as the sIRB. On a given study, the sIRB can track whether or not a site has signed their LOI on the Status Summary tab and the Status Summary Export. Now, the Status Summary export will also include the date participating sites signed the LOI. Additionally, the Status Summary export has been updated so that the date of initial approval is always included. The export still includes the most recent approval date, if there are approvals beyond the initial approval.
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: Up to Date IREx Resources
It has been a busy season in IREx with many updates, so the resources below now reflect the new features.
Updated Feature: Enhanced PDF Export of Local Considerations Surveys
Local considerations received another enhancement this month: PDF Exports of the surveys now include embedded HRPP Liaison and PI signatures, respectively, rather than including the signatures as separate files. These surveys record important study-specific information and support national sIRB initiatives.
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.