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Study Personnel Roles in the ERICA Application

Effective January 13, 2018, the ERICA application uses a new model for listing study personnel.  The model is explained below, allowing personnel to be listed on the ERICA application pages as described.

ERICA Study Personnel Model

All personnel on this page must have an ERICA account to be added.  

Responsible Investigator 

This person has ultimate responsibility for the ERICA application. The Responsible Investigator can create, edit, and submit all components of the application. The Responsible Investigator also receives all study-related notifications from the ERICA system.

Faculty Sponsor to the Responsible Investigator

A Faculty Sponsor is required when the Responsible Investigator's position is not Faculty or Non-Academic Equivalent.  The Faculty Sponsor has read-only access to applications in ERICA and receives all study-related notifications from the ERICA system.

Contact Persons for the Responsible Investigator

Contact persons entered on this page have access to edit all components of the application and receive all notifications from the ERICA system. These individuals are expected to report to the Responsible Investigator for the purposes of the IRB application and can be contacted if more information is needed regarding any component of the application.  

Guests of the Responsible Investigator

Guests entered on this page can view the full application in ERICA and do not receive study-related notifications from the ERICA system.  If you need Guest Access for an auditor or monitor, please contact the IRB.

All personnel on this page must have an ERICA account to be added.  

Site Principal Investigator (Site PI)

This person is responsible for all research activities conducted at the study location. The Site PI has read-only rights to the application, unless the 'Same as Responsible Investigator' box is checked or the Site Control Option is activated, which provides edit rights.

The Site Control Option is a feature that will not be activated in ERICA until February 2018. It allows the Site PI to view the full application, as well as edit and submit the site-specific application on which they are listed. The Site PI also receives all study related notifications from the ERICA system related to the site-specific application on which they are listed.  

Training and conflict of interest are verified by the ERICA system for this person. 

Site Contact Persons

These individuals are expected to report to the Site PI for the purposes of the IRB application and can be contacted if more information is needed regarding the procedures conducted at their study location.  

Site Contact Persons have read-only rights to the application, unless the 'Same as Contacts for Responsible Investigator' box is checked or the Site Control Option is activated, which provides edit rights.

The Site Control Option is a feature that will not be activated in ERICA until February 2018. It  allows Site Contact Persons to view the full application, as well as edit the site-specific application on which they are listed. Site Contact Persons also receive all study related notifications from the ERICA system related to the site-specific application on which they are listed.  

Training is verified by the ERICA system for these individuals. 

Site Staff and Sub-Investigators

These individuals have a role and responsibility for the design, conduct, and/or reporting of the research described in the application. These individuals are expected to report to the Site PI.

Site Staff and Sub-Investigators have read-only rights to this application.  They do not receive study-related or site-related notifications from the ERICA system.  

Training and conflict of interest are verified by the ERICA system for these individuals.

Site Guests

Guests entered on this page can view the full application in ERICA, as well as the site-specific application on which they are listed. These individuals do not receive study-related notifications from the ERICA system.  If you need Guest Access for an auditor or monitor, please contact the IRB.

Personnel on this page may or may not an ERICA account to be added.  Those with an ERICA account have access to the application as described for each role below; those without an ERICA account do not have any access to the application.  

Site Principal Investigator (Site PI)

This person is responsible for all research activities conducted at the study location. 

ERICA Access: The Site PI has read-only rights to the application, unless the 'Same as Responsible Investigator' box is checked or the Site Control Option is activated, which provides edit rights.

The Site Control Option is a feature that will not be activated in ERICA until February 2018. It allows the Site PI to view the full application, as well as edit and submit the site-specific application on which they are listed. The Site PI also receives all study related notifications from the ERICA system related to the site-specific application on which they are listed.  

Training and conflict of interest are not verified by the ERICA system for this person. 

Site Contact Persons

These individuals are expected to report to the Site PI for the purposes of the IRB application and can be contacted if more information is needed regarding the procedures conducted at their study location.  

ERICA AccessSite Contact Persons have read-only rights to the application, unless the 'Same as Contacts for Responsible Investigator' box is checked or the Site Control Option is activated, which provides edit rights.

The Site Control Option is a feature that will not be activated in ERICA until February 2018. It  allows Site Contact Persons to view the full application, as well as edit the site-specific application on which they are listed. Site Contact Persons also receive all study related notifications from the ERICA system related to the site-specific application on which they are listed.  

Training and conflict of interest are not verified by the ERICA system for these individuals. 

Site Guests

ERICA Access: Guests entered on this page can view the full application in ERICA, as well as the site-specific application on which they are listed. These individuals do not receive study-related notifications from the ERICA system.  If you need Guest Access for an auditor or monitor, please contact the IRB.

For individuals who are affiliated with locations supporting the research, but do not need UU IRB approval to cover their activities, please name the individual and describe their role on the study as part of the Resources and Responsibilities page.  

These individuals may

  1. have approval from another IRB for conduct of research on this project 
    or
  2. are not 'engaged in research' and do not need IRB approval for their involvement

Frequently Asked Questions

Why is this change being made?

The University of Utah IRB is expanding to cover research at more locations than the University of Utah and our standard Affiliate institutions (Primary Children's Hospital, Veterans Affairs SLC Health Care System, and Shriner's Hospital for Children Intermountain).  Because of this, the ERICA application needed a more accurate way to align study personnel with their study locations. 

What if the PI and study personnel are the same across multiple Affiliate sites (e.g. the University of Utah, Primary Children's Hospital, Veterans Affairs SLC Health Care System, and Shriner's Hospital for Children Intermountain)?  Do I have to re-enter the same PI and contacts for every site?

No. You can sync all of the site investigator fields and site contacts fields with those listed on the Study Introduction page.  When adding information about the study location, select the "Same as Responsible Investigator" box and the "Same as Contacts for Responsible Investigator" box to sync these fields, so you only have to enter these personnel once.  

How will training requirements and conflict of interest requirements be verified for study personnel?

ERICA will verify training requirements for the following personnel:

  • Site PIs at Affiliate Locations
  • Site Contacts at Affiliate Locations
  • Site Staff and Sub-Investigators at Affiliate Locations

ERICA will verify conflict of interest requirements for the following personnel:

  • Site PIs at Affiliate Locations
  • Site Staff and Sub-Investigators at Affiliate Locations

The ERICA application will continue to display training dates and conflict of interest dates for these individuals.  As always, IRB approval will not be issued for studies if training requirements and conflict of interest requirements are not completed.  

For existing applications with IRB approval, do I need to update the study personnel to fit this new model?

We have tried to align the study personnel from all existing applications to the new model automatically; however, this alignment may not be perfect.  Please double-check the study personnel at your next amendment or continuing review and make any adjustments as needed.

Will studies still show up in my ERICA inbox in the same way?

Yes. All users with an ERICA account have an ERICA inbox and studies that they are listed on show up in that inbox.  

What is the difference between the Default Option and the Site Control Option that is referenced in the ERICA application?

This will officially be announced in February 2018, when the Site Control Option is implemented in ERICA.  

How do I get an ERICA account for non-University of Utah personnel?

Non-University of Utah personnel can get an ERICA account in three different ways.  See the ERICA Access Instructions for more information.  

 

Last Updated: 1/17/19