1. Structure of Industry Budgets
Suzan Bruce, CPC
Coverage Analysis Coder
Clinical Trials Office, CTSC

2. Components of a clinical trial budget:
Start up costs
Close out Costs
Invoiceable Costs
Per Patient Costs
Budget Summary

3. Budget Template CTO Webpage:

4. Build Shell UBT Build UBT Shell CPT Codes CRC/PI Time Start Ups
Billing codes for study account
“Other” costs
Cost estimates from other depts.
IDS Dispense Fee
Radiology –Lab-
Build UBT Shell
Per SOP #8 the UBT is required for all industry sponsored studies
We build a UBT so we can determine internal costs for the study
The UBT includes study specific activities like start up costs and invoiceables as well as per patient activities
The protocol may require procedures that need to be provided by other hospital or clinic depts.
To build the UBT:
Who, what, where, when, how, services are provided so I can budget for the activities in the protocol. Are these activities billable CPT codes? Or are the activities budgeted in time for the CRC and PI
Start with asking the dept questions about the Procedures.
Their answers determine whether or not there are billable services to the study
Will there be “other” costs
Will the study need billable services from other departments? Radiology? Lab? Gather CPT codes to look up research costs
Do I need to request cost estimates from other department’s? IDS, CCRC, clinical engineering?
CRC/PI Time
Start Ups
Start Up, Close Out, Invoiceables
Time on SOE activities
Difficulties: Takes time to work out and track details with dept.
Tips: Use Budget Feasibility form to track detailed information

5. Start Up Costs

6. Start-up Costs Start-up fees should always be non-refundable
Study invoiceables=start up, study specific invoiceables.
I have a list of fees we charge for start ups, annual fees, and invoiceable fees.
In order to calculate the fees, we ask the CRC and study personnel specific questions about the invoiceables
How much PI, CRC, time? Time costs are based on Research personnel salaries
Template is on the CTO Webpage

7. TOOL: Develop List of Start Up Fees

8. Per Patient Costs

9. Procedures CPT Codes
Other Costs
CRC Time
PI Time
TOTALS
Per Patient Costs Page lists costs per patient, per visit
Procedures
Other Costs like IDS, Stipend
Study Activities include CRC time x salary
PI Activities include PI time x salary
Salary Calculator -links all salary costs throughout the budget

10. Sample UBT CPT Codes
Procedures CPT Codes
Turn to the Per Patient Cost page
To determine costs for study procedures I will ask the CRC specific questions
Examples of questions I ask:
Where are the visits? (In research space ?in clinic space?=billable CPT code)
Who is taking blood? (If hospital’s lab=billable CPT code. If CRC=CRC time)
Is sponsor providing equipment for study (EKG)?=If sponsor provides=no billable CPT code. If using dept EKG=billable CPT code
List Procedures and their costs by department
Use Cost Query Tool to find costs

11. Find Research Costs Cost Query Tool on CTO Webpage Search by: CPT code
EPIC Procedure Code
Procedure Name
Cost Center Name

12. Find research costs on CTSC Webpage

13. Search tool Search costs CPT Code
Search for costs within your department or other departments using the cost query tool
Many different ways to search

14. “Other” Costs

15. List Other Costs Per Visit
List “other” costs by visit

16. Costs
CRC and PI Time

17. CRC/PI Time Time Costs Totals Section total
List protocol required activities from the schedule of events.
Ask CRC/PI how much time is needed for services at each visit
Total the time for each activity = costs
Totals

18. Unified Budget Template (UBT) Summary Shows internal cost assuming full enrollment of patients completing entire study
Enter Budget Totals

19. Prepare Budget for Sponsor
Review Sponsor Budget
Excel spreadsheet sponsor sends
Review Clinical Trial Agreement
Compare with internal costs
UBT
Sponsor’s payment terms
Prepare Budget for Sponsor
Prepare to negotiate
Review sponsor’s budget in excel spreadsheet
Review Clinical Trial Agreement Terms
Compare sponsor’s budget with internal costs
After comparison enter amounts you want to negotiate into the sponsor’s budget spreadsheet
Invoiceables
Start up Estimator
Use estimator as a guide
List specific invoiceable items
Difficulties: Takes time to work out and track details with dept.
Tips: Use Budget Feasibility form to track detailed information

20. Compare Internal UCD Costs VS Sponsor’s Budget

21. Compare Costs UBT vs Sponsor Budget
Internal Budget (UBT)
Here you are comparing the sponsor’s budget with the internal budget
You are reviewing the sponsor’s initial budget offer and comparing to the
UBT (internal budget)
If internal budget amounts are more than sponsor’s budget update sponsor’s budget to begin negotiations
Tips: Create a space on UBT to add sponsor’s budget totals. Compare invoiceable and per patient totals to analyze internal costs and sponsor’s budget.
Sponsor Budget Total
Internal Per pt Total

22. Negotiate Costs Using Sponsor’s Budget

23. Sponsor Negotiation
Use sponsor’s budget to enter amts you want to negotiate
Use sponsor’s budget to enter amts you want to negotiate
Use the sponsor’s budget to negotiate with the sponsor
Use it to enter the amounts you want to negotiate
Sponsor reviews our initial budget offer and begins negotiations
We do not send the sponsor our internal costs
We aren’t afraid to ask sponsor to pay our the UCD chargemaster rates. Use them as a starting point if you aren’t sure what to charge
Difficulties: Managing multiple communications
Tips: Track all communications using electronic tools (excel, Microsoft Project, calendar, etc.)

24. Add Sponsor Amounts Negotiated

25. Add Sponsor’s Budget to UBT
Here you are comparing what we are being paid vs the sponsor’s rates you are negotiating
Compare the UBT and sponsor amounts and see if you are gaining or losing money for the study
Compare

26. Total All Budget Amounts- Submit totals to Contracts Office

27. Finalize amount for contract packet
Ensure all numbers in the UBT and contract documents are accurate and match
Enter final budget amounts into the contract documents
This creates a dollar amount for the Contract Office to open the study account
Sponsor Budget
Internal Budget (UBT)

28. Julie Calahan Budget Analyst Contracts Office Budget In Service Training jecalahan@ucdavis.edu

29. Questions???