Whether you are developing your own budget or the sponsor presents you with one, your clinical study budget should cover all study-related costs, including fees and indirect costs.

Most of your costs will be calculated per patient and/or per procedure, but some may be one-time costs or fees. Examples of costs that may not be included in the per patient cost include:

• Advertisement costs.
• Screen failures.
• Prorated payment for subjects who are terminated, drop out, or are lost to follow-up.
• Startup costs: Upfront, nonrefundable payment to defray the cost of startup work such as preparing regulatory documents, attending investigator meetings, site initiation training, enrollment efforts, etc.
• Payment for close-down costs in the case of early termination by the sponsor.

For clinical trials proposed under a federal grant or contract or similar mechanism, be sure that personnel costs are appropriately allocated to the personnel budget or to the per-patient study costs.

The protocol may state that certain items or services are "free” to all research subjects. The budget and/or agreement should include these services. Even if these services normally would be considered standard of care, if the sponsor has agreed to pay for them, they may not be billed to the patient or the patient's insurer.

Procedures for Research Study Participant Payments

If a budget offered by a sponsor is inadequate to cover costs, you will need sufficient evidence to support your request for additional funds. The more ammunition you have in support of reasonable and customary costs in your area, the better your chance of obtaining increased funding.

Budget review

Numerous rules and regulations govern the conditions under which a clinical service, item, or test may be billed to the patient, to Medicare, or to a third-party insurer. It is essential to understand whether a trial involving a test drug or device is a “Qualifying Clinical Trial” as defined by the regulations of the Centers for Medicare and Medicaid Services (CMS). Further, the study budget must be analyzed to ensure that study costs are correctly distinguished from costs related to the standard care for a patient.

The University of Maryland Medical System (UMMS) Research Billing Compliance Office will work with the principal investigator and study staff to determine whether the trial is a Qualifying Clinical Trial and to help develop the financial aspects of the budget. Ultimately, the clinical study funding agreement or award terms must harmonize with the study budget, the study protocol, the research subject informed consent document, and any other study-related documents. The investigator and department remain responsible for development of the grant or contract proposal and budget.  Contact the UMMS Department of Finance at 410-328-5991 for assistance or more information.