What

FACTS Office – Budget Development & Negotiation Services

The Financial Administration of Clinical Trials Services (FACTS) office provides investigators the option of using their budget development and negotiation services for industry sponsored clinical trials. FACTS will incorporate their fees into the budget and charge sponsor for these costs.

Develop and Negotiate Your Own Budget

If the research team chooses to develop and negotiate their own budgets, please consult with your research administrator for department specific resources and fees. In addition, see the tools listed below to assist researchers with budget development and negotiation.

Tools

  • Budgeting Guidelines
    • FACTS – Refer to the section entitled “Budgets” for the following:
      • Budget Development Tips
      • Budget Templates
      • Budget Negotiations Presentation
        • Budget Negotiations for Industry Clinical Trials
        • Industry Sponsored Device Trials
  • Institutional Fees
    • Administrative Fees (Start-up, Maintenance, Close out) – Refer to the Budget Negotiations Presentation under “Budgets“.
    • Facilities and Administrative (F&A) Costs
    • ISMMS IRB Fees – Refer to the section entitled Information for Sponsored Research
    • FACTS – Fees
    • Investigational Drug Service (IDS) – Usage Fees
    • Clinical Research Unit (CRU) – Fee Schedule
    • Medicare Coverage Analysis (MCA) Fee  – FACTS Fees

How

To use FACTS Budget Development and Negotiation services, email FACTS@mssm.edu or call (646) 605-7251.

When you submit your contract through MediTract (FACTS), you will be asked to indicate who will be negotiating the budget. If the study team chooses to negotiate the budget, the FACTS office will reach out to the study team to obtain the final negotiated budget.

When

Budget development and negotiation should occur concurrently with contract negotiations and IRB submission.

Biomedical Research Alliance of New York (BRANY)

BRANY is a research consortium owned by several New York metropolitan area institutions, including the Icahn School of Medicine. BRANY offers a variety of services, including:

  • IRB review
  • Budget negotiation and  contracting for multisite studies
  • Monitoring services for  investigator initiated studies
  • Medicare Coverage Analysis (MCA)

To use BRANY services, please email FACTS@mssm.edu for more details and for the fee schedule.

Indirect Costs and Budgets

Indirect Costs, also referred to as “Facilities and Administrative (F&A) costs” or “overhead”, are required to be applied to the total direct clinical costs for industry sponsored clinical trials.  Exception – IRB fees are exempt from F&A costs.

The indirect cost rate for Industry Initiated or Sponsored Trials is 35%.

Waiver: If the industry sponsor or other funding source will not pay the current F&A rate, a waiver is required from the Chief Financial Officer (CFO). Requests should be made in writing or email by the Chair or Administrator of the Principal Investigator’s Department. Unless the Chair is also the Principal Investigator (PI) the request should not come from the PI. If the waiver is not granted, the department will need to supplement the difference.

For more information, refer to Policies and Procedures for Charging Indirect Costs to Sponsored Projects Received from Extramural Sponsors, Gifts, Donations, and Other Receipts.

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