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Home Guidance ERICA Site Control Model Closing Participating Sites

When the University of Utah is serving as the single IRB (SIRB) for a multisite study, there are situations where one of the Participating Sites (pSites) completes all study activities and/or is no longer engaged in research requiring IRB oversight before the rest of the study is complete.

How do I determine whether a site is ready to close their IRB application? 

Use the standard criteria for a Final Project Report to determine whether a pSite 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. Complete all identifiable data transfers between the sites before initiating site closure.

I have a site that is eligible for closure. How do I get this started? 

If the site is connected to the main IRB application (i.e. the traditional ERICA model), 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 (pSite) Closure Report: 

  1. Go to the study workspace in ERICA. Click on the "Sites" tab to see a list of your current sites.
  2. If there are hyperlinks for each site in the "Site" column, that means the site is using the ERICA Site-Control Model. Proceed to #3 below to continue. If there are no hyperlinks in the "Site" column, your application is using a traditional model. Submit an Amendment to request closure of the site.
  3. Click on the "Site" link for the site you would like to close. This will take you to the Participating Site Workspace.
  4. Under "Activities" on the left of the screen, click on "Create Site Closure Form".
  5. Fill out the closure form and click "Submit" to send the form to the IRB for review. You will receive a letter from the ERICA system when the closure has been approved. Remember to share the closure letter with the pSite study team, including the IRB/HRPP at the site.

Will fees be charged for sites that are closed?

Fees are charged for sites as long as they're open and need IRB oversight. While we do not charge a SIRB fee for a pSite Closure Report, you may receive an invoice when you submit a pSite Closure Report. This is because SIRB Fees are charged for the previous year's oversight.

The IRB does not charge SIRB fees for amendments, individual attached documents, or report forms (e.g. unanticipated problems, protocol deviations, etc.). All of those services are wrapped into the "ongoing/annual review” fee which you can find on the fee quote you received as part of the study Reliance Consultation process. Each annual fee covers the services the SIRB provides for the previous approval period. This is important to note when you submit your Final Project Report** for the overall study –  or a Closure Report for a Participating Site – you will get an invoice at that time. The invoice is not for the closure itself, but rather for the final year the project was open.  

For example, the annual review fee is due in 2026 for oversight for 2025-2026, the fee is due in 2027 for oversight from 2026-2027, etc.

If you close a site within three (3) months after the last continuing review/progress report approval, no annual pSite fee will be charged with the pSite Closure Report.

**If Final Project Report fees are applicable to your study per the Individual Site Fee schedule (e.g. for industry sponsored studies), they will be charged when the main application is closed, not when individual sites are closed.