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Home Guidance ERICA Site Control Model Adding Participating Sites for Site-Control Management

 

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. Step 2 is to submit the PSA for IRB approval.

 

Step 1: Add the Site to the Main Application

  1. Create an Amendment. The purpose of this Amendment is not to get IRB approval for the site, just to start the technical process of creating a PSA for the site.
  2. Fill out the Amendment application.
  3. Click "Update Study" from the Main Workspace, and navigate to the Study Locations and Sponsors Page. 
  4. On Question #1, click the "+Add Other Location" button and add your new site's information.
    • TIP: If you cannot find your site in the ERICA directory, it means your site has not been added to the database. Contact your IRB staff point of contact, or send an email to sirb@utah.edu to request your site be added. We will need the site's name, where they are located, and their FWA number (if applicable). If they have a website, it is also helpful to include it. We will notify you when the site has been added. 
  5. The application will require you to list a Site Principal Investigator (S-PI). This person is responsible for all research activities conducted at the study location. The Responsible PI must decide if they would like the S-PI to have some access to the study in ERICA, and receive notifications affecting their site directly from the ERICA system. If yes, the S-PI must have their own ERICA account.
    • To learn more about how to obtain an ERICA account please visit our ERICA Access Instructions.
    • You may list the S-PI in the PSA before they have an ERICA account, but they will not have access to the study and will not receive notifications until they are added to the study via their active account.
    • In the screenshot below, if the S-PI is listed in the blue section, they will not have access to the study in ERICA. If you can search for them and add them in the yellow section, they have an ERICA account and will be able to see the study when they log into ERICA.ERICA Site Information shows two options for managing site information. Default and Site Control option. Fillable fields including Site Name, Site PI and Email Address are showed in the picture
  6. Click "Save" and exit the Update Study Application. The only change should be to add the site; do not make any other changes with this Amendment. You may add multiple sites at once if you need to.
  7. From the main study Amendment workspace, click "Submit" under the Activities menu to send the Amendment to the IRB for processing.

 

The Amendment will move to "Reliance Confirmation" status and will be routed to your Reliance Reviewer. The reviewer will activate the site-control model for your Amendment and create a PSA for the new site. You will receive a notification from ERICA when the application is ready and the PSA is in “Creation” status. Your site will NOT be IRB approved following this step. Complete Step 2 to submit your site for IRB approval.

For Step 2, go to Submitting a Participating Site Application (PSA).