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Clinical Research Compliance and Education (CRCE)

Clinical Research Compliance and Education (CRCE)

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 subjects 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. The Clinical Research Compliance and Education team manages the University Tracking of Clinical Research (uTRAC), our clinical trials management system which plays a crucial role in efforts to meet clinical research compliance obligations. 


ANNOUNCEMENTS

EPIC AND RSH WQ UPGRADE INFORMATION

The Epic upgrade scheduled for April 7, 2019 will impact the Research Workqueue (RSH WQ) and research charge review process. CRCE staff members will be providing several training sessions
March 18th – April 12th to prepare research teams for this change. We highly recommend that those who have access to the RSH WQ attend a live training at HSEB OR a webinar to learn about these changes.

  • Epic Upgrade Training: Four live training sessions will be held in the HSEB on the health sciences campus, once each week.
  • Epic Upgrade Webinar: We will be holding eight webinars, twice each week.
  • Workshops: We will be adding an additional workshop the week after the Epic upgrade. Additional workshops will be added, as necessary. Our regularly-scheduled workshops will have CRCE staff ready to help answer questions as well.

In addition, charges entered prior to the upgrade will require special attention if they are not cleared from the WQ before the upgrade takes place; it will be in your best interest to review and clear as many charges as possible from your research WQs prior to April 7th.

To find the schedule and register for these training sessions, please go to our CRCE Training Calendar on Pulse.  If you have any questions or concerns about the uTRAC upgrade or training, please contact
Tonya Edvalson or Summer Davis.


EDUCATIONAL OPPORTUNITIES

The CRCE team offers many educational opportunities to provide study teams and research investigators the tools that they need to meet compliance needs in research. 

  • Webinars and Workshops to assist with uTRAC applications.
  • Epic training for certain billing functions.
  • Research Education department in the Research Administration Training Series (RATS) regarding financial matters and FDA matters.
  • Individualized training to meet the needs of specific study teams and departments.

 

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 CRCE Pulse Calendar.  See below for upcoming dates and times

 

  1. 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.

Upcoming Dates:
April 4, 2019                11:00 AM – 1:00 PM
May 7, 2019                 1:00 PM – 3:00 PM

 

  1. 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 and Clinical Trials National Coverage Decision review, and budgeting considerations. This webinar is required for study team members who will be completing Protocol Billing Grids (PBG) and Medicare Coverage Analysis (MCA) in uTRAC. 

Upcoming Dates:
May 20, 2019               10:00 AM – 12:00 PM
May 27, 2019               11:00 AM – 1:00 PM

 

  1. 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 chartfields (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.

Upcoming Dates:
April 9, 2019                10:00 AM – 12:00 PM
May 16, 2019               9:00 AM – 11:00 AM

 

  1. 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 Protocol Billing Grids (PBG) and Medicare Coverage Analysis (MCA) in uTRAC. 

Upcoming Dates:
April 24, 2019              2:00 PM – 4:00 PM
May 28, 2019               10:00 AM – 12:00 PM


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 is necessary, so please feel free to come at any time we are scheduled. 

Upcoming Dates:
April 2, 2019                2:00 PM – 4:00 PM
April 9, 2019                1:00 PM – 3:00 PM
April 11, 2019              9:00 AM – 11:00 AM
April 17, 2019              9:00 AM – 11:00 AM


EPIC CRC END USER – RESEARCH WORKQUEUE

This class will review will the requirements to ensure that research participants are correctly registered in uTRAC in order to be linked to Epic and charges linked to the study visit. This is all 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. 

Upcoming Dates:
April 23, 2019              1:00 PM – 3:30 PM
May 16, 2019               1:00 PM – 3:30 PM

 


RATS PROGRAM

CRCE participates in several RATS classes offered by the Research Education department.  Please refer to their website for full descriptions, schedules, and registration: Research Education

Offered:  February, April, June, August, October, December

Upcoming Dates:
April 18, 2019 10:00 AM – 12: 00 PM

 

Offered: Fall Semester, Spring Semester

Currently Scheduled Date: N/A

 

Offered: Fall Semester, Spring Semester

Currently Scheduled Date: N/A

 

Offered:  Fall Semester, Spring Semester

Currently Scheduled Date: N/A

 

Offered:  Fall Semester, Spring Semester

Currently Scheduled Date: N/A

 

INDIVIDUALIZED TRAINING

Departments and/or study teams that would like a member of CRCE to work with their groups on a particular topic, please let us know. You can contact Tonya Edvalson to discuss the issue(s) you would like to address and plan an agenda to best meet your needs.

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Last Updated: 4/13/21