Clinical Research Compliance & Education Information

May 9, 2019

The Clinical Research Compliance and Education (CRCE) Office is a core team within Compliance Services at the University of Utah. The CRCE team facilitates processes, provides training and education, and engages in oversight activities designed to ensure that clinical services associated with human subject research are charged to the correct party, that claims submitted to government health care programs comply with the requirements of the applicable program, and that human subjects research complies with expectations imposed by the federal Food and Drug Administration.

University of Utah Health Clinical Trials Website

Did you know that the University of Utah Health (U of U Health) website has a page dedicated to clinical trials and can be a resource for patients to learn more about your research studies?

uTRAC and ERICA can combine information to populate a page available to the public about research projects at the U of U Health once your study is approved by the IRB. The Clinical Trials website provides patients with information about research, including a search function to locate research studies that could be of interest to them. The University of Utah Health Clinical Trials Website Tip Sheet is available on Pulse. We hope that this Tip Sheet provides study teams with the information they need to utilize the U of U Health website in ways that better promote studies and the research that our institution is doing for the community.

If you have questions about uTRAC and how to access the U of U Health Clinical Trials website for your study, please feel free to reach out to the CRCE team or (801) 213-3601. Sadie Gabler, Director of Research Participant Advocacy, can answer specific questions about the website.

uTRAC Webinar Training

These webinars provide training to understand the application process necessary to track clinical research billing at the University of Utah. There are four webinars in the series. All webinars are offered once each month. To register for these classes, please see our CRC Pulse Calendar. See below for upcoming classes:

Draft Training: This class covers the step-by-step process of creating a uTRAC application. Participants can watch as the instructor creates a new study application in uTRAC. We will discuss the history of uTRAC, how uTRAC integrates and interacts with other University systems, uTRAC requirements, and the uTRAC workflow. This webinar is not required; however, it is highly recommended for those completing applications in uTRAC.
MCA/PBG Training: Studies that intend to bill insurance for any study-related procedures must complete a Protocol Billing Grid (PBG) and Medicare Coverage Analysis (MCA). Each study team is responsible for conducting its own MCA analysis. We will cover PBG completion, Medicare coverage of clinical services in research, prospective reimbursement analysis, Clinical Trials National Coverage Decision review, and budgeting consideration. This webinar is required for study team members who will be completing Protocol Billing Grids (PBGs) and Medicare Coverage Analysis (MCA) in uTRAC.
Active Training: This webinar will review the step-by-step process of managing a uTRAC application after it has been reviewed, approved, and is advanced to the awarded state once IRB approval is in place for the study. Participants can watch as the instructor activates an awarded application and demonstrates the process of enrolling research participants in the study. We will review updating Chartfield (account numbers), tracking research participants, and amending the application in uTRAC. This webinar is not required; however, it is highly recommended for those completing applications in uTRAC.
ePay Review Training: For each study that has Epic billable charges routed to the study for payment, that study must assign at least one person to review and approve charges within uTRAC. This webinar will cover how these charges are reviewed and billed via an ePay in uTRAC (an electronic version of the original paper campus order). A step-by-step demonstration will show how this review and workflow occurs. We will also provide information about how individuals can become approvers (signatories) on a study account and other billing considerations. This webinar is required for study team members who will be completing ePay reviews in uTRAC.
Epic CRC End User – Research WorkQueue (RSH WQ) Training: This class will review the requirements to ensure that research participants are correctly registered in uTRAC in order to be linked to Epic and that all charges linked to the study visit. This is necessary so that charges are held prior to being released to the patient’s guarantor account. Step-by-step instruction of the Research WorkQueue (RSH WQ) will identify appropriate routing of charges to the study account or research patient account, as appropriate. Research staff members who are responsible for clearing research charges from the Epic system are required to take the CRC End User training before getting access to the RSH WQ for their department. Registration is managed through LMS.

Workshops

Workshops are weekly open sessions where CRCE subject matter experts are available to assist study teams and investigators with clinical research billing questions, uTRAC applications, and Epic charges. We meet in the Eccles Health Sciences Education Building (HSEB) computer lab (Room 3100) with computers available. No registration necessary, so please feel free to come at any time we are scheduled. You may register to let us know you are coming and have LMS provide you with an automatic way to add these to your calendar.

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