In the past, when a new review is added to a study in IREx, sites’ status changed from “Approved” to “Not Approved” since they haven’t been shared the new approval yet. To improve clarification and uploading of new approvals the approved site’s status will now change to “Approval Pending” until the sIRB or Study Manager shares the new approval with the site.
Category Archives: Study PI
Updated Feature: Hide Versions side bar on Study Page
The Versions side bar has been removed from the IREx study page. In the past, the Versions panel was used to locate past approvals but is no longer needed as sites can view all of their approvals on the Approval History tab. The sIRB and Study Manager can view all study-wide approvals on their Study-wide IRB Approvals tab.
Updated Feature: Approval notifications include new Approvals Quick Guide
All relying site approval notifications are updated to include text and a link to the Approvals Quick Guide for helping study teams locate their approval documents:
“*NEW* We’ve made accessing your approval documents more user friendly – use this Quick Guide to see changes.”
Updated Feature: Date Added is now Date Approved
For better clarification, the Date Added column has changed to ‘Date Approved’ to indicate the date documents were approved on the Study-wide and Site-Specific IRB Approvals tabs. SIRBs and Study Managers can also see the Date Approved column when uploading approvals for the Lead Site and Relying Sites.
Updated Feature: The Determination Letter Has Been Renamed to “IRB Approval Documentation”
The Determination Letter document type has been renamed to “IRB Approval Documentation” for better clarification since not all institutions call the approval from the IRB a determination letter.
Updated Feature: Other IRB Approved Documents Has Been Renamed to “Additional IRB Approved Documents”
The document type, Other IRB Approved Documents has been renamed to “Additional IRB Approved Documents” to help differentiate from the “Others” document type – which are documents not approved by the IRB.
Updated Feature: Site-Specific IRB Approvals tab now specifies Study-wide Amendments
The Site-Specific IRB Approvals tab now includes a “Study-wide Amendments” label to help clarify study-wide vs site amendments.
Updated Feature: Search box now searchable by FWA number on the Find other sites page and Agreement checker
Users accessing the ‘Find other sites’ page and ‘Agreement checker’ can now search a site by FWA number in addition to the site name.
Updated Feature: One PI Survey per FWA engaged in a Combo Site
PIs will now complete a separate PI survey for each FWA in a Combo Site, with the option to copy their PI survey responses from the other site in the study. A separate PI survey allows for more accurate capture of the conduct of the study for each site in a combo. As with all sites on a study, the HRPP of a site in a Combo validates the PI survey responses
Updated Feature: Updated PI Studies Dashboard
Lead and Participating Site PI Dashboards have been updated to include the study title, PI’s local site name, Reviewing IRB, current study expiration date, and a To Do column that lists the next step for your site. The dashboard includes sorting and searching capabilities.