Clinical research budgeting is completed by study teams via OnCore and is supported by the CTSI's Office of Clinical Research. The process of clinical trial budgeting is completed to assess how much it will cost to conduct a study as compared to the fees which a sponsor has agreed to pay. Use our Internal Budget Template to begin reviewing the projected costs of the research study and prepare for industry initiated (non-Federal) negotiations.
Because clinical research often takes place in conjunction with routine clinical care, it is important to ensure billing for clinical and research procedures is handled appropriately and in compliance with legal requirements.
A Medicare Coverage Analysis (MCA) involves determining the study's eligibility for Medicare coverage and reviewing the clinical events specified in the protocol to determine appropriate Medicare reimbursement.
This institution requires an MCA on all clinical research in which any tests, procedures, or interventions on study subjects are billed to third party payers. The Office of Clinical Research performs a thorough Medicare Coverage Analysis, consulting investigators when necessary to incorporate their expertise and insight, on all industry sponsored studies submitted to the IRB. Industry sponsored studies that bill tests, procedures or interventions to patients and/or patients' insurance as Routine Care will be charged $1,500 per MCA; all other studies receive Medicare Coverage Analysis at no cost.
Medicare's Clinical Trial Policy (NCD 310.1) only allows coverage of routine costs during a qualifying clinical trial. Medicare will not cover routine costs paid for by the sponsor, promised free in the consent form, or solely to determine trial eligibility or for data collection purposes.
If you are using CRMS or OnCore for financial management, then the study participants need to be logged and tracked in the system.
The Office of Clinical Research (OCR) has centralized industry-sponsored clinical trial invoicing and the payment receipt process to reduce the burden on research staff. The OCR will invoice industry sponsors monthly for all budgeted costs (e.g. subject visits, patient stipends, administrative fees, etc.). Research account statements from Encompass and payments made directly to participants will still be the responsibility of the study team. All payments from industry-sponsored clinical research and non-industry clinical research will be received by the OCR.
NOTE: If a sponsor does not provide enough information to properly identify which study the payment belongs to, the Office of Clinical Research will send the check to financial services to be deposited into a clearing account. Upon receipt of the identifying information, OCR will transfer the funds to the appropriate chartfield.
[CRMS will be phased out by the end of Calendar Year 2019, and all studies will have migrated to OnCore. You will be notified by the Office of Clinical Research once your study has been successfully migrated to OnCore. At that time, all data entry should take place in OnCore only.]