Planning Guide

Create the Budget

1. Review Protocol

2. Identify CPT codes (contact appropriate coders to obtain codes) and ARUP charge codes (ARUP site) that will be used to conduct research

3. Determine what professional services can be provided and budgeted as time/effort (most often applies to federally-sponsored studies)

4. Prepare Detailed Internal Budget and Classify Patient Care Costs Utilizing uTRAC

a. Complete the Protocol Billing Grid(PBG) to:

• Determine Technical & Professional patient care costs (see How to Acquire Pricing)
• Identify other per patient costs (IDS, CCTS)
• Perform Medicare Coverage Analysis (MCA) for patient- billable costs (requires uTRAC MCA/PBG Automation training to complete)
• Calculate time/effort costs
• Calculate inflation and F&A

b. Complete uTRAC Budget to determine startup, maintenance, and closeout costs

5. Submit uTRAC Draft for Reviews

6. Negotiate budget with Sponsor (and ask OSP to insert helpful contract language based on your budget development), if applicable

7. Submit final Detailed Internal Budget and Budget Summary to OSP (and submit grant application, if applicable)


Prepare for Study Commencement

1. Link uTRAC application to IRB application before IRB submission

2. Obtain any required trainings for scheduling Epic study visits, ordering ARUP labs and other ancillaries, and reviewing/reconciling Epic/ePay charges (http://healthsciences.utah.edu/crce/training/index.php)

3. Once uTRAC is moved to the “Awarded” state, activate uTRAC application


Manage the Study

1. Enroll participants into uTRAC prior to first study visit

2. Log visits in uTRAC utilizing the visit log in uTRAC

3. Manage study finances


a. Charge all study costs to project
b. Charge study personnel costs to project

i. Time effort (link to personnel costs page) coverage appropriate for most grants
ii. CPT coding (link to patient care costs) for personnel time appropriate for most industry-sponsored trials

c. Invoice sponsor
d. Reconcile sponsor reimbursement
e. Reconcile Patient Care charges

i. Review Epic WQ charges for appropriate routing of charges and placement of modifiers
ii. Review and approve study-billed ePay charges in uTRAC

f. Review monthly Management Reports


Close the Study

1. Reconcile final project costs

2. Transfer residual funds

3. Close uTRAC project