Guidance for charging a management direct fee to industry-sponsored clinical trials
Industry-sponsored clinical trials typically have complex financial and administrative management needs that go beyond the standard facilities and administration costs incurred as indirect expenses on projects. These clinical trial management activities include, but are not limited to:
- facilitating and supporting the complex financial management of trial awards
- budgeting and invoicing
- scheduling patients
- tracking patients’ visits for billing
- trial startup
- trial close-out
Such costs may be incurred as direct expenses on industry-sponsored awards. In some cases, UCSF departments may pool and incur costs centrally to support industry-sponsored projects. When clinical trial management costs are incurred centrally within a unit, an internal fee based on a percent of total direct costs, or other negotiated or calculated amount, may be assessed as a direct cost charge on industry-sponsored clinical trials to defray the full cost of providing this function. When used, this fee should be included in the clinical trial’s total direct cost base budget, which is then used to calculate indirect costs at the institutionally approved industry clinical trial rate. A management direct fee may be applied only to industry-sponsored clinical trial projects and may not be assessed on federal sponsored clinical trial projects.
Clinical trial management cost categories include, but are not limited to:
- Salaries, wages, and benefits of staff devoted to clinical trial management with specialized training in clinical research and medical procedure billing compliance (i.e. research coordinators, study coordinators)
- Other FTE related expenses:
- General, Automobile, and Employment Practices Liability Assessment (GAEL)
- Data Network Recharge
- Computing and Communication Device Support Services
- Central Data Center Services (when applicable)
Departments wishing to charge an industry-sponsored clinical trial management direct fee should charge clinical trial management efforts and expenses to a central department project, credit this project using Account 54301 to offset these expenses, and debit the clinical trial projects with the management direct fee using Account 54301. Costs for regular fiscal oversight (e.g., ledger reconciliation) should not be included in the clinical trial direct management project.
Departments must establish and implement internal departmental guidelines for treatment of any residual surplus balances or covering shortfalls in the central administrative project.
The Budget and Resource Management Office will ensure that clinical trial management costs will not be included in the campus F&A rate administrative cost pools. Therefore, recovering these costs through a clinical trial management direct fee will not result in duplicate reimbursement from the Federal government or other non-Federal sponsoring agencies.
Departments wishing to charge federally sponsored projects for direct management expenses (e.g., research or study coordination) should budget directly for the actual effort of staff and associated expenses on awards or should follow campus guidelines for establishing a recharge activity.