Subject Related Cost Budget

When a study is set-up in OnCore, the calendar and the Coverage Analysis will be completed for you.  In addition, OnCore contains an internal Charge Master that provides many of the medical services costs that are part of the cost budget.  Allowing for these processes to complete prior to starting the cost budget, ensures the study team, administrative team, hospital billing department are all working from the same calendar of events and coverage analysis.  This creates a starting point to compile the cost budget of the study.

The calendar with the coverage analysis overlaid can be exported from OnCore by running the “Budget Calendar” on the “Subject-Related” screen in the Financials Console.  Running this Budget Calendar using the “Research” Cost option will provide a starting point to the subject-related budget.

At a high level, the process flow is:
Process Flow
Calendar of Events
  • Each procedure, panel, and the lab is pulled from the Protocol using Sponsor's terminology to create the events/lines on the OnCore calendar
Coverage Analysis
  • Determine if the study is "Qualified" Clinical Trial
  • Identify which events will be paid by Insurance/Subject and which paid by the sponsor/trial
  • Tie each procedure, panel, and lab to a CPT code that contains the cost to the study
Add Other Costs
  • Export Calendar from OnCore
  • Add study team effort and other needed supplies/services not already included
  • Add F&A, inflation factor and contingency percentage
Budgeted Total Costs
  • The amount that needs to be covered by the negotiated budget
  • Budgeted Cost input into OnCore as the "Research" amount
Cost vs. Negotiated Budget
  • Budgeted Costs are stored separately from Negotiated Budget and used for different financial review purposes
  • Comparison of cost and negotiated budget used to estimate ending cash balance/deficit

The export can occur once the Coverage Analysis is complete.  To this exported worksheet, the following budgetary items need to be added to arrive at your Budgeted Total Costs:

1. ​Effort of all people directly working on the study
2. Other supplies and services that will be required to be purchased in order to complete the study
3. F&A
4. Inflation Factor
5. Contingency Factor​
5. Cost amounts for medical services missing from the export​

Please use the above links to access this information.

An example of the lines added to the OnCore exported subject-related budgeted could look like:

 Treatment Follow Up Total
 Screening 1@1Days


12 Cycles @ 7 Days

 ScreeningDay 1Week 2Week 4Week 8Week 12Follow Up 
Total Direct Costs for "Per Visit" Milestone784.81804.01804.01593.06376.50804.01868.315,034.71
F&A at 28% of Total Direct Costs219.75225.12225.12166.06105.42225.12243.131,409.72
Total Costs for "Per Visit" Milestones1,004.561,029.131,029.13759.12481.921,029.131,111.446,444.43
Total Costs including Inflation Factor1,045.541,071.121,071.12790.09501.581,071.121,156.786,707.36
Contingency Rate of 3%31.3732.1332.1323.7015.0532.1334.70201.22
Targeted Total Costs to Recover1,076.911,103.261,103.26813.79516.631,103.261,191.496,908.58
Once the cost budget is completed, the Excel file should be stored as an attachment in the Financials Module of OnCore.

Please remember that once the contract budget negotiations are complete, the negotiated amounts should be compared to the budgeted amounts in the cost budget and extended by the estimated number of enrollments to determine the projected cash balance at the end of the study.  

An example of this comparison may look like:

Sponsor's Schedule of Events Plus Medicare Coverage Analysis

*Tied to a Price List Event

CPT Code or Unique IdentifierVisit 1Visit 2Visit 3Visit 4Total Costs
Total Direct Costs per Visit 264.00214.00144.0090.00712.00
F&A 73.9259.9240.3225.20199.36
Total Cost per Visit 337.92273.92184.32115.20911.36
Total Cost Including Inflation Factor 374.33303.44204.18127.611,009.56
Contingency at 5% 18.7215.1710.216.3850.48
Budgeted Cost Including Inflation/Contingency 393.05318.61214.39133.991,060.04
Negotiated Price per Contract 500.00250.00200.00100.001,050.00
Surplus/(Deficit) 106.95(68.61)(14.39)(33.99)(10.04)
Number of Estimated Enrollments     55.00
Estimated Surplus/(Deficit)(552.20)
CMS Login