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: December 2019
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.