Budget 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. In addition, you should ask whether other study-related costs will be paid, such as - advertisement costs
- screen failures
- prorated payment for subjects who are terminated, drop out, or are lost to follow-up
- up-front, non-refundable payment to defray the cost of start-up 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
Most of your costs will be calculated per patient and/or per procedure, but some may be one-time costs or fees. For clinical trials proposed under a Federal grant or contract or similar mechanism, be sure that personnel costs are appropriate allocated either 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 would normally be considered standard of care, if the sponsor has agreed to pay for them, they may not be billed to the patient or his insurer. If a budget presented by a sponsor is inadequate, 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 in the Center for Clinical Trials (CCT) 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. CCT’s analysts 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, coordinating closely with the University of Maryland Medical Center and the University Physicians, Inc. When the budget is complete, they communicate this information to the contract administrators who are working with the award or negotiating the clinical study agreement. 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. Online education about clinical research billing is available. Communication and Routing Proposals and Pre-award: Investigators preparing grant proposals can request a meeting with a Clinical Trial Analyst to determine what the proposal should include as it relates to the CMS Clinical Research Policy prior to submitting the proposal to the funding agency. The Clinical Trial Analyst can review the protocol and obtain information regarding the specifics of the research to advise whether the research is subject to the CMS Clinical Research Policy regulations. When the proposal has been funded, a full compliance review may be required, depending on the type of clinical trial. Funding from government and nonprofit organizations: Proposals should be routed according to standard procedures. The Office of Research and Development reviews proposals and awards. Funding from corporate sources: The CCT Clinical Research Request Form must be completed and submitted for all clinical studies. The clinical study agreement will be negotiated by a contract administrator from the Office of Research and Development. The Principal Investigator will be notified as to the individual in ORD who will negotiate the agreement and the person in CCT who will be responsible for analyzing the billing plan and study budget. In general, corporate-funded clinical studies should be routed after the budget is prepared and final. ORD's agreement negotiator will need sponsor contact information and a complete set of study information, such as any contractual documents provided by the sponsor, the confidentiality agreement, and the protocol. In addition, be sure to inform the negotiator of all locations, whether on- or off-campus, where UMB research subjects will be treated. After the study agreement has been fully executed (signed by UMB and the Sponsor) and the routing has been received, the Office of Research and Development will process the agreement so that a Project ID can be assigned. back to top | 
