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.
Category Archives: IREx Study Manager
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: Tracking Changes to the Local Considerations HRP Survey
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: 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: 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: Include date local considerations surveys were “Updated”
Sometimes Study Managers (SMs) or sIRBs need PSites to make changes to the local considerations they provided in IREx. Before receiving sIRB approval for a study, PSite HRPPs and PIs can make these edits to the Human Research Protection (HRP) and PI surveys (Note: PIs can only make edits before their HRPP validates their answers). IREx will now track when updates were made by the PI or HRPP and include this date on the Status Summary tab so Study Managers can see when the information was last updated.
New Feature: Download a Report of Your Status Summary Tab
IREx Study Managers and Reviewing IRB Liaisons can download a CSV export of the Status Summary Tab for each study. On the Status Summary Tab, click Export Data > Export Status Summary Tab to download the data displayed on the Status Summary Tab.