Whether you are creating a budget or reviewing one provided by a sponsor, your clinical study budget must account for all study-related costs, including fees and indirect costs.
Types of Costs
Most costs are calculated per patient and/or per procedure, but some may be one-time costs or fees, such as:
- Advertisement costs
- Screen failures
- Prorated payments for subjects who terminate early, drop out, or are lost to follow-up
- Startup costs: Upfront, nonrefundable payments to cover activities like preparing regulatory documents, attending investigator meetings, site initiation training, and enrollment efforts
- Close-down costs: Payments in the event of early termination by the sponsor
For federally funded trials (grants, contracts, or similar mechanisms), ensure personnel costs are properly allocated either to the personnel budget or the per-patient study costs.
Free Services and Standard of Care
Some protocols may provide items or services that are “free” to all research subjects.
- Even if these services are normally standard of care, if the sponsor agrees to cover them, they must be included in the budget or agreement.
- These items may not be billed to the patient or the patient’s insurer.
Research Study Participant Payments
If the sponsor’s proposed budget does not fully cover costs, you must provide sufficient documentation to justify a request for additional funding.
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The more detailed and evidence-based your cost justification, the better your chance of obtaining additional support.
Procedures for Research Study Participant Payments
Budget Review and Compliance
Clinical trial budgets must comply with regulations and billing rules, including:
- Determining whether a trial involving a test drug or device qualifies as a “Qualifying Clinical Trial” under CMS regulations
- Ensuring costs are correctly classified as study-related vs. standard of care for patients
The UMMS Research Revenue Integrity (RRI) team collaborates with principal investigators and study staff to:
- Confirm whether the trial meets CMS Qualifying Clinical Trial criteria
- Develop the financial aspects of the budget
The clinical study funding agreement or award terms must align with:
- The study protocol
- Research subject informed consent documents
- The overall study budget
- Other study-related documentation
Investigators and departments remain responsible for developing the proposal and budget. For assistance or more information, contact UUMMS RRI at research.umms@umm.edu.