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.”
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.
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.
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.
The Site-Specific IRB Approvals tab now includes a “Study-wide Amendments” label to help clarify study-wide vs site amendments.
Users accessing the ‘Find other sites’ page and ‘Agreement checker’ can now search a site by FWA number in addition to the site name.
All emails for studies that are part of the Trial Innovation Network (TIN) now include the sentence “This study is part of the TIN” for added clarity and searchability.
sIRBs and Study Managers can now close sites on studies. A reason or reasons for closure, date of closure, and determination letter are required to post a site closure. Closing a site sends a notification to the site’s HRPP and study team members and archives all past approvals so that no documents can be downloaded. Participating sites continue to have access to site closure documentation for 30 days after a site closure is submitted, after which the site cannot access the study in IREx. A listing of closed sites is available to sIRBs and Study managers on the Status Summary tab. For further information, see the Site Closure Quick Guide.
sIRBs can now close studies that are complete on IREx by uploading the reason and date of closure, as well as the IRB determination letter. Closing a study notifies sites that the study has ended. The study remains accessible to all registered sites after a closure is posted, and all past approvals become read-only. A record of sites’ reliance details and a history of sIRB site approvals are still available in all IRB exports for metrics. For instructions on how to close a study, see our Quick Guide.
Here is what you will see for a closed study:
The “New IRB Approval For Your Site” email, sent when the SIRB or SM has documented a new approval, now includes updated guidance on how PIs and study teams can access approved study documents for their site.
