Corporate Budgeting Issues

Corporate Agreements are not limited to Clinical Trial (Human Subject) studies. Any agreement with an industry sponsor can have some shortcuts that will help smooth the negotiation and project execution.

  1. Read the protocol or research plan
    • Regardless if it is industry or university initiated, the work plan will help determine many budget issues and planning concerns as you go forward
    • Ask the PI to consciously determine if the level of scientific endeavor is worth exploration of the relationship
  2. With project plan in mind, determine the amount of time, patient population, milestones (including enrollment targets, adverse events), and final publications that might influence the timeline
  3. Independent of any financial indications from the sponsor, internally determine the cost of doing the project. Cost out all real expenses over the life of the project:
    • Faculty and technical support time (research assistants or nurses)
    • GSRA? Needs tuition
    • Administrative and financial accounting time (non-federal sponsors allow recovery of these costs as a direct item)
    • IRB fee (Currently $1800 for all new industry contracts)
    • Advertising
    • Drug set up and dispensing
    • Patient Visits
    • Patient Reimbursements (Subject Fees, Volunteer Parking, Focus Group Food)
    • Patient Tests
    • Animal Models (45% Quality Assurance Fee applies to purchase and housing)
    • Publications
    • Travel to and from Study or Scientific Meetings
    • Screen Fail Compensation
    • Adverse Event Reporting
    • Computer for data collection
    • Filing Cabinets for data storage
    • Offsite Space
    • Compensation to other investigators for subject recruiting time (Notice: Not an incentive per patient!)
    • F&A Recovery:
      • 25% if the project is under an open and active IND or IDE with the FDA
        • applied to all costs except IRB fee
      • 58% if the industry sponsored project is considered on-campus research – applied to costs that are allowable under Federal negotiated agreement
      • 32% for off-campus research (over 50% of the UM involvement has to take place outside of UM facilities. At the VA, for instance)
        • applied to costs that are allowable under Federal negotiated agreement
      • 32% Other sponsored activity
        • applied to costs that are allowable under Federal negotiated agreement
  4. Separate budget items by type of cost – particular to patient enrollment studies
    • Determine which costs are start-up (not dependent on enrollment)
      • IRB, Advertising, Screen Fails, Drug Dispensing Set-Up, Cancer Center Clinical Trials Office administrative fee, Investigators’ meetings during the trial
    • Determine which costs are patient dependent activities
      • Office Visits, Tests, Blood Draws, Screen Fails, Subject Fees
    • Determine which costs are close-out and independent of patient enrollment
      • Publications, data storage
    • ** For projects that are investigator initiated, this is the point that the PAF would start routing through the sponsored project system. Drop down to VII. Routing…
  5. Negotiating the budget with the sponsor for clinical trial protocols
    • Consider listing all costs as a combination of DC an F&A
      • $500 for travel to a meeting would be $790 (58%)
      • Industry sponsors are likely to be looking for a bottom line to fund – why “confuse” the issues with our internal F&A rates?
      • Post –Award becomes very fluid in the assignment of costs and final reporting
    • Negotiate flat costs as separate reimbursements than per patient events
      • A contract that garners $1800 for an IRB Fee and $1562 for advertising ($1250 + 25%) regardless of patient enrollment is much more viable if it enrolls no patients in competitive enrollment than one that has the costs built into the per patient amount
  6. Revisit the Protocol and Budget
    • Is it still worth doing the project based on the funds you can recover form the sponsor v. costs of doing project here? Patient population still viable and attainable at this point?
  7. Routing through Medical School
    Once you have an expectation of doing the project and a reasonable budget agreement with the sponsor (even if it is not in the final contract terms, but you have email or verbal confirmation of the representation) route the PAF through the sponsored project system
    • Parts to route:
    • PAF
    • Statement of Work (can be the opening sections of the protocol)
    • Draft of agreement (unless investigator initiated)
    • Budget
    • If investigator initiated, should have budget going to sponsor as well as internal budget if a flat amount budget (F&A combined into line items) was used
    • If industry initiated, copy of the payment terms in the draft agreement along with an internal budget showing how costs are expected to be distributed at UM

Routing Hints:

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