Subject-related activities include all those activities required to prepare, complete, document as well as complete the administrative activities for invoicing the sponsor and tracking the payments.
Like Protocol Management, the first step is to identify all activities that will be performed during each contact with a subject. These activities can be identified by asking questions like the following:
1. What procedures, labs, and panels will be performed at each visit?
2. Who will provide these services? Where will the subjects be seen?
3. What are the costs of these services?
4. What effort will the study team expend for each visit or phone contact?
5. What is the size and length of the study?
6. What is the complexity of invoicing the sponsor per the study contract?
Answers to the above questions can be found in the following resources:
2. Informed Consent Form (ICF)
3. Draft Contract
4. Principle Investigator (PI)
5. Sponsor Contact
Not only do these resources provide unique information, but they also – in some instances – provide the same information. For example, the draft budget in the draft contract (i.e., the initial proposal from the sponsor in the negotiation process) should contain all of the procedures that each subject will go through. This list of procedures in the draft contract budget must also match the procedures listed in the protocol and the ICF. The importance of consistency between these documents cannot be overstated. Any discrepancies should be resolved with the sponsor, prior to completing the budget negotiations, so that the final versions of these documents are in total agreement.
The PI on the project is also a resource that can provide clarification and additional information you may need when developing a cost budget.
While the specific language of each protocol differs, there is standardization of what information must be included. In identifying all of the required activities for the subject-related events, the following parts (or similarly entitled parts) of the protocol often provide most of the information you need to build the subject related budget.
Protocol Introduction/Background in the Protocol/Study Summary
Understanding the context of the study can be very useful in many ways. But certainly it helps to:
1. Interpret the specific medical labs, panels, and procedures that are referenced in the Protocol’s schedule of events.
2. Understand more about the investigation product (drug, biologic or device)
3. Understand the size and length of the study.
Study Objectives and Endpoints in the Protocol
As you would expect, this will provide a description of the final outcome. The specific goal of the study. In addition, it can also provide information about how much data will be collected at each visit, and therefore insight into how much study team effort may be reasonable.
Schedule of Events
This part of the protocol lists all labs, procedures, panels, surveys, and questionnaires that will be performed at each subject visit/contact. This schedule is at a summary level. Additional detail is often needed to fully understand what is planned to happen at each subject contact. This additional detail is often found in the Treatment Plan/Study Plan and the ICF.
Treatment Plan/Study Plan
These sections of the protocol will provide additional detail of the Schedule of Events. This additional information will help to understand if the CPT codes that are identified in the Medicare Coverage Analysis (MCA) seem reasonable. In addition, it will help provide data that can be used to determine if the effort of the study team, and/or PI seems reasonable.
Remember to cross reference the data in the Protocol, ICF, draft contract budget to ensure that events that will be completed at each visit is consistent.
The above data is what the calendar builders will use in the development of the OnCore Calendar, and the coverage analysts use in the development of the Medicare Coverage Analysis (MCA), and therefore the basis for compiling the 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.
This information 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 cost budget.
To ensure that CU Anschutz (and UCHealth if applicable) is using the same calendar, it is recommended to use this exported calendar as the starting point for budgeting the subject related events rather than creating your own, or using the sponsor’s initial budget.
At a high level, the process flow is:
|Calendar of Events|
|Add Other Costs|
|Budgeted Total Costs|
|Cost vs. Negotiated Budget|
After exporting the budget calendar with the research cost from OnCore, a complete review of this initial budget should be completed to verify that the calendar is what you expected and that it matches and contains all of the events required by the protocol, draft contract budget and Informed Consent Form.
Once it is determined that the calendar from OnCore is correct, then the remaining budgetary events can be added to the exported calendar to calculate the total estimated costs of each event:
1. Add any costs for patient services that are not included in the exported budget. Commonly missing costs include services provided by entities other than UCHealth.
2. Effort of all people directly working on the study
3. Other supplies and services that will be required to be purchased in order to complete the study
5. Inflation Factor
6. Contingency Factor
The final outcome of the excel budget including the above items may look something like:
12 Cycles @ 7 Days
|Screening||Day 1||Week 2||Week 4||Week 8||Week 12||Follow Up|
|Total Direct Costs for "Per Visit" Milestone||784.81||804.01||804.01||593.06||376.50||804.01||868.31||5,034.71|
|F&A at 28% of Total Direct Costs||219.75||225.12||225.12||166.06||105.42||225.12||243.13||1,409.72|
|Total Costs for "Per Visit" Milestones||1,004.56||1,029.13||1,029.13||759.12||481.92||1,029.13||1,111.44||6,444.43|
|Total Costs including Inflation Factor||1,045.54||1,071.12||1,071.12||790.09||501.58||1,071.12||1,156.78||6,707.36|
|Contingency Rate of 3%||31.37||32.13||32.13||23.70||15.05||32.13||34.70||201.22|
|Targeted Total Costs to Recover||1,076.91||1,103.26||1,103.26||813.79||516.63||1,103.26||1,191.49||6,908.58|
It is acceptable to either average a study team’s effort over all of the visits, or estimate the effort for each individual visit. Don't forget to include the time it takes for the study team member to prepare for and document the visit in addition to the actual time the visit will take.
Just as a reminder… Your PI may provide both clinical services and oversight/management activities to the study. The clinical effort – is really providing clinical services. Clinical services are to go through CU Medicine for billing and also for proper tracking of the Base, Supplemental, and Incentive components of the faculty compensation plan. Therefore, this expense will generally be booked to the account code of 535207 – UPI Physician Billings.
If the PI’s effort is for activities related to the management of the study (either protocol-related activities of subject-related activities), this effort should be booked via the CU payroll system, as part of the “CU Position Funding” functionality in HCM. Therefore, this expense will generally be booked to the Salary and Benefits account codes.