I have been added to a site on a study, why can I not edit/view the main study within ERICA?
Only the main study personnel have access to the main study application. If you’ve only been added as part of a site, that will be the only area of the study you have access to.

What is the difference between a study location and a site control location?
Site control locations are included on a study as an additional location where a portion of the research  takes place. They are overseen by personnel at the site and can have their own documentation and personnel. Each site control location will go through a separate approval process . Details of what’s done for the study at these locations are dictated by the main study’s application.

Study locations are similar in that they can have additional personnel added specific to the location, but they use the documentation from the main study application, and are overseen by the study location personnel.

Which site personnel have to site applications?
There are different kinds of access in a site application:
- Site PI’s, Site Faculty, and Site Contact Persons all have access to view the site application.
- Site PIs and Site Contact persons have the ability to edit the site application.
- Site and Study PIs are the only ones who can submit an application.

Does an amendment for a site require an amendment to be created on the main study?
No, site amendments can be submitted and processed separately from the main study.

I am trying to create a site amendment, but the system won’t let me. Why?
This is caused by an outstanding study continuing review or amendment with the site selected. Only one application can be open for any site at a time.

Will  my site be included as part of all amendments that are made on a study?
No, your site will only be included if the amendment affects your site directly.

Can my site create their own final project report outside of the main study?
Yes, a site may create their own final project report outside of the main study.

Can a continuing review for a site be created separately from a study’s continuing review?
No, a site continuing review will be created simultaneously with a study continuing review.

Why can’t I submit my application?
This will be determined based on the role that you have within a site. Site PI’s, Site Faculty , and Site Contact Persons all have access to view the site application, but only the Site PI and Study PI have the ability to submit a site application.

I am having trouble with my site application, who can help?
The Responsible Investigator and all Study Contacts have access to edit the site application and can assist if needed. If they are unsure of how to help/proceed please contact: irb@hsc.utah.edu

heard the term “Site Bundling”, what is that?
“Site Bundling” is a  term used to describe the process of grouping the study application and the site applications together to move them to the next phase of the application approval process. Examples of these phases would be “Submission” and “Final Approval”. Site bundling can be initiated at multiple steps during the approval process for Continuing Reviews, but it automatically occurs for study amendments where sites are impacted by the changes. The only way a site may be 'bundled' on a Continuing Review is if the appropriate actions have been taken on the site application, and it is ready to move to the next step. For example: filling out all required fields on the site application before the study application is submitted. By 'bundling' these applications together, only one action is required to advance the approval process instead of one action per submission.