Industry-Initiated Budgeting and Financial Support


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.

  • Specifications (visit schedules): The specification (visit schedule) acts as a 'schedule of events' for the study team and as a billing grid to route research-related charges appropriately in OnCore. 
  • Budget: The budget in CRMS/OnCore details the amounts which the study sponsor will be paying. For additional guidance developing a non-Federal budget, please see the Research Fees for Industry Budgets spreadsheet. This document offers guidelines for potential fees to consider for a non-Federal budget. The minimum and maximum ranges are not institutionally required, but are meant to provide a framework for budget development.
  • Clinical Research Pricing: Study teams can find clinical research pricing using OnCore. Please refer to the step-by-step instructions provided below.   
    • OnCore Clinical Research Pricing
    • Fee Schedule and F&A rates by funding source and type of study
  • Workshops: Clinical Research Budget Workshops are offered monthly from 2-3 pm in a 3 month cycle. Study Start-up, Study Maintenance, and Closeout topics rotate each month.  Initiations will be sent out monthly to OnCore users.  For additional information, or in person workshops, please contact

Medicare Coverage Analysis (MCA)

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 Standard of Care will be charged $1,500 per MCA; all other studies receive Medicare Coverage Analysis at no cost.

Medicare's Clinical Trial Policy 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.

Study Invoicing

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 WakeOne 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.

If a study is in CRMS, the following steps will occur:

  • Invoice created to show what visits and invoiceable events the check is paying for
  • “Check received” activity used to document receipt of check
    • Copy of check uploaded in CRMS – PI name, GTS#, IRB # and chartfield noted on check
    • The study team received an automated email from the CRMS indication the check has been received.  The email will include a link to the PDF copy of the check and any supporting documents
  • Check sent to the cashier’s office to be deposited

[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.]

If a study is in OnCore the following steps will occur:

  • All study visits must be logged into OnCore by the study team via the calendar tab of the subject console in order for the visit to populate on an invoice.  The Office of Clinical Research does not have access to the study EDC and cannot enter visits on behalf of the study team.
  • Invoice created to show what visits and invoiceable events the check is paying for
  • "Receipt" logged in OnCore to document check no., amount, date received, date deposited, date reconciled, invoices and payments applied as well as sponsor
    • Copy of check uploaded in OnCore in Financials Console > Attachments - PI name, GTS#, IRB# and chartfield noted on check
    • The study team can review payments received for their studies by going to the Financials Console of OnCore and clicking on 'Receipts' on the left-hand menu.
  • Check sent to the cashier's office to be deposited

If a study is not in CRMS or OnCore, the following steps will occur:

  • PI name, GTS#, IRB # and chartfield noted on check
  • Study team emailed check has been received with copy of check attached to the email
  • Check sent to the cashier's office to be deposited