Generally, industry sponsors are concerned with the total cost of conducting a project rather than the classification of costs. As a consequence, the structure of most clinical trial budgets differs from that of grant proposal budgets. Sponsor-provided budget templates are typically separated into up front costs, per patient costs, and items to be invoiced on an as needed basis. Other budget issues for considerations are listed below:
When preparing and negotiating the budget for an industry sponsored clinical trial (not investigator-initiated), be sure to cover all costs associated with conducting the trial. Due to the unique administrative nature of clinical trials and the reduced facilities and administrative rate currently being applied to clinical trials, charging administrative expenses may be appropriate if the sponsor will cover these costs as a direct charge. For clinical studies conducted for industry sponsors, administrative costs may be directly charged to the award using one of the following methods:
- Direct charging administrative salaries and expenses to the private clinical trial fund and/or
- Assessing an internal departmental administrative charge of no more than 9.5% of Total Direct Costs (TDC) against the private clinical trial fund. (9.5% represents an estimate of departmental costs based on the difference between the fully approved department administration facilities and administrative rate applied to research projects and the department administration facilities and administrative rate applied to clinical trial funds).
If the second method is used, an internal departmental recharge fund must be established to properly accumulate administrative salaries, benefits, and expenses related to private clinical trial funds and record recharge income. This recharge should be assessed monthly and should not generate a profit, but cover actual costs of providing administrative support to private clinical trial funds.
All departmental administrative charges regardless of the method used will be assessed the applicable facilities and administrative rate approved for the clinical trial fund.
Patient Care Costs and Coverage Analysis
To obtain a coverage analysis and current research rates for patient care costs, including Pharmacy services, see Clinical Research Finance Assessment (CRFA).
The Institute for Clinical Translational Science (ICTS) offers a variety of services to support clinical and translational studies. For more information, see Institute for Clinical and Translational Science services.
The Institutional Review Board (IRB) charges fees for the review of clinical trials from for-profit sponsors. For a current listing of fees, please see the IRB Fees sheet.
Facilities & Administration Fees
Costs for travel to Investigator's Meetings or other study-related meetings may be managed in a variety of ways. Be sure to clarify how such costs should be incorporated into your study budget, if appropriate. See Special Travel Considerations for Trials for more information.