When the University of Utah is serving as the single IRB (SIRB) for a multi-site study, there are situations where one of the participating sites completes all study activities and is no longer engaged in research requiring ongoing IRB oversight.
Use the standard criteria for a Final Project Report to determine whether a site can be closed.
When evaluating the closure criteria: “Data analysis is complete OR if you are continuing or planning to analyze data, the data does not contain participant identifiers or a link/code to identify study participants,” it is expected that personnel from the closing site will no longer be engaged in research activities requiring IRB approval, and that if identifiable data is still being analyzed that originated from the participating site, it will be transferred to another open site for analysis. Identifiable data from the site can continue to be used by investigators still covered by an active IRB approval.
If the site is connected to the main IRB application, submit an Amendment to the main application and report that the site is closed. It is helpful if you note the Final Project Report criteria in the Amendment. The IRB staff reviewer may follow up and ask you to answer the criteria questions in the application. The main application will remain open until the entire study (including the Data Coordinating Center [DCC], if applicable) has completed all study-related activities and qualifies for a Final Report.
Studies using the ERICA site-control model can submit a Closure Report on the Participating Site Application at any time.
To start a Participating Site Final Project Report:
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- From the Sites tab, select the site.
- From the site Workspace, under “Activities”, select “Create Site Closure Form”.
- Complete and submit the form.
Keep in mind that SIRB fees (if applicable to the study) are charged for the previous year’s work, so an invoice is sent when the Final Project Report is submitted, when appropriate. The IRB does not charge SIRB fees for amendments, attached documents, or report forms (e.g. unanticipated problems, protocol deviations, etc.). All of those services are wrapped into the “ongoing review” fee, which covers the work the SIRB does for the previous year’s work. This is important to note when the study submits its Final Project Report – or a Closure Report is submitted for a Participating Site – they will get an invoice at that time. The invoice is not for the closure, but rather for the final year the project was open.