A new email notification is now sent when any existing approval – for the overall study or a participating site – is updated. For example, if additional documents are uploaded or exchanged, an email will notify the relying site’s HRPP and study team personnel of the revisions and the exact changes are detailed in a table. The notification will bring clarity to the email notifications and ensure sites are aware of updates or changes to their approval, as specified in section 5.9 of the SMART IRB Agreement, “Notification of IRB Decisions, Changes, Lapses in Approval.”
Category Archives: IREx Study Manager
New Feature: SSRP Included in Local Considerations Export
A PDF of each site’s Study-specific Reliance Plan (SSRP) is attached to the Notification of Reliance email sent when the SSRP is accepted by a site; however, sIRBs were previously unable to download site-specific SSRPs from within IREx. Now, the Local Considerations (LC) export will include a PDF of each site’s SSRP. The LC export will continue to include each site’s Institutional Profile, HRP survey and PI survey, if LC are being captured in IREx, as well as any documents uploaded to those surveys.
Bug Fixes – December 6, 2019
Fixed: Documents attached to Institutional Profile, HRP Survey, and PI Survey are back in Local Considerations export.
Updated Feature: Notifications when Local Considerations are Edited
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.
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: 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.