Serving Michigan
Trial Budgeting
Research study budgeting and billing is a complex topic that is study-specific. Considerations must be made regarding the study budget based upon specific research activity, what is expected of the research participant and supporting research staff, data collection and analysis, the Institutional Review Board (IRB) fees and any equipment or software required in the process of conducting the research.
Each study is addressed individually. It is highly recommended that the Principal Investigator (PI) seek consulting services by the Trinity Health Office of Research & Innovation – West Michigan to determine the trial budget, billing, potential for a Medicare Coverage Analysis, the process to obtain Guarantor and Series Account numbers and other aspects of research participant billing support, whether it be for Investigator Initiated or Sponsored Clinical Trials.
Costs to consider when budgeting for research purposes include:
- Time and effort of all staff (including Principal Investigator)
- Space to conduct research visits
- Equipment that might be used for study purposes
- Institutional Review Board (IRB) fees
- Laboratory specimens, imaging studies, X-rays, etc.
- All clinical procedures
- Survey tools (if Copyright protected and restricted use)
- Supplies
- Indirect rate (where applicable)
The Finance Analyst for clinical research will assist in appropriate pricing of all research activities and will complete a Medicare Coverage Analysis when deemed necessary.
Prior to submitting for IRB approval, grant funding or the purchases of any equipment, please make an appointment to consult with staff of the Office of Research & Innovation. In preparation for the consultation, please provide a completed protocol to the Office of Research & Innovation with the intention of allowing a review of the proposed research prior to the appointment. This can be done by submitting a consultation request and attaching the necessary document(s).
Helpful Links
Centers for Medicare & Medicaid Services (CMS):