Institutional Review Board

If your study is using the ERICA "Site-Control Model", adding a new site is a two-step process. Step 1 is to add the site to the application so a Participating Site (pSite) Application (PSA) can be created. For Step 1, go to Adding Participating Sites for Site-Control Management.

After a site has been added to a study and a Participating Site Application (PSA) has been created, you can submit the PSA for IRB approval.

1) Find Your Participating Site Application.

• From the Main study workspace, click on the “Sites” tab to see a list of your sites and their current status.
  • TIP: You can also access the PSA by clicking on the "IRB" tab at the top of your ERICA homepage, which will open your “In Progress” page for all applications, PSAs, etc. that are currently in an unfinished stage of the IRB approval process. Any PSAs in "Creation" status will be listed in the section labeled “Sites”. Clicking on the name of the site will take you site's PSA.

2) Complete Site Approval Prerequisites.

• The IRB will need the following information before we can approve a site for enrollment. Do not submit the PSA to the IRB until you have verified all of the following items are complete:
  1. Reliance has been confirmed between the University of Utah IRB (UU IRB) and the site's Human Research Protection Program (HRPP). Your IRB Reliance Reviewer can help you find this information.
  2. The site's Institutional Profile and Local Context Information has been provided to the UU IRB. Your IRB Reliance Reviewer can help you find this information.
  3. The site-specific consent document (if the site is enrolling participants) with their local language inserted (and a tracked copy of the document showing the site-specific changes compared to the template approved for the main application) has been prepared and attached to the PSA. Any other site-specific documentation should also be attached to the PSA Documents page.

     **IMPORTANT NOTE: The Responsible PI (R-PI) is responsible for all documents submitted to the IRB for review and approval, including site-specific documents submitted by Site PIs (S-PI) as part of their PSA. To facilitate IRB review and prevent administrative delays, make sure you are reviewing documents for each of your sites before sending them to the IRB.

     • Design Your SIRB Consent Documents: We recommend researchers use a "two-part consent model" for their multisite research. We can help you prepare your templates for IRB approval.
     • Submitting Documents for IRB Approval: We have specific formatting requirements for processing consent documents in ERICA. Make sure you have correctly formatted your documents to prevent technical errors during final processing.

3) Complete and Submit the PSA.

• From the PSA workspace, click the “Edit Application” button in the left-hand menu.
  • Who can edit an application? Study PIs, Study Contacts, Site PIs, and Site Contact Persons will be able to edit the application. Only the S-PI or R-PI can submit the application to the IRB.
    
• Complete the application per the on-screen instructions.
  • At the bottom of each page of the application there are three buttons: “Exit”, “Save”, and “Continue/Finish”. These can be used at any point during the application process. “Save” will save the current version of the application. “Exit” will exit the application and return to the main page for the site. If there are any unsaved changes to the application and the exit button is clicked it will ask whether to save the changes or not. “Continue” will advance to the next page in the application.
  • TIP: After all the necessary information has been provided, click on the “Validate” button in the top-left corner of the editing window. This will bring up a menu with a warning for any missing fields that need to be completed before the application can be submitted.

    If you click on the blue text link to the right of the warning icon, you will be taken to the affected portion of the application. Update the missing information accordingly and click the “Save” button at the bottom of the page. When the “Validate” window updates it should show the warning message has been cleared.

• On the final page of the application, click the “Finish/Exit” button to save your work and navigate back to the PSA workspace.

4) Set Responsible PI Preferences.

• The ERICA Site-Control Model allows the R-PI to set submission controls for each individual site. You can see what the R-PIs preference is set to from the Site Information Page in the PSA:
  
• From the PSA Workspace, the R-PI will have an activity called "Edit Responsible PI Preferences". A pop-up window will show the options the R-PI can select for this S-PI.
  
• Each site can be managed individually:

5) Submit the Participating Site Application to the IRB for review.

• From the PSA workspace, the PI can click "Submit" to send the PSA to the IRB for review.
  

The PSA will move to "Reliance Confirmation" status and will be routed to your Reliance Reviewer. The reviewer will verify that Reliance has been appropriately completed and documented, and that site-specific documents are compliant with local considerations. You will receive a notification from ERICA when the application has been approved.

• You can follow the progress of your ERICA application by comparing the status label with our ERICA Status Key.
• General timelines and review schedules for the IRB can be found on our Submission & Review Schedules page.