The Approvals Versions box, located on the left-hand bar of a study page, has been enhanced so that studies with numerous sites can easily view SIRB approvals sorted by Relying Sites and sites who are Registered/In Progress. In addition, the Approvals Versions box now features a scroll bar so users can quickly navigate to view a site’s approval status.
Category Archives: IREx Study Manager
New Feature: sIRBs are no Longer Required to Upload Overall Approval for Continuing Reviews & Study-wide Amendments
To further streamline the work of the sIRB in IREx and avoid delays in posting approvals, the Study Manager can now post the overall/lead site approval for continuing reviews and amendments. In the past, the sIRB had to upload this before the Study Manager could upload approvals for Relying Sites. Now, this is a single process that can be completed by the Study Manager.
The sIRB is now only required to create the study and post the overall study or lead site approval initial approval. Thereafter, all approval documents are managed by the Study Manager.
Updated Feature: Single Entry of Team Personnel Added by Study Manager
The site contacts (e.g., PI or Coordinator) listed by the Study Manager will auto-fill as members of the study team when the Participating Site HRPP registers for a study. This allows the HRPP Liaison to confirm existing contacts, rather than having to re-enter the contact information. After the HRPP liaison has registered and confirmed the contacts, they receive access to IREx and the study. After a site has registered, the PI and Coordinator information is locked to the Study Managers, so the site edits personnel if needed.
New Feature: Email Notifications for Updated Approvals
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.”
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.