A-7.3) Management Direct Fee on Industry Sponsored Clinical Trials

Review date

Guidance for Charging a Management Direct Fee to Industry-Sponsored Clinical Trials

Definition

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 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. A management direct fee may be applied only to industry-sponsored clinical trial projects and may not be assessed on federally sponsored clinical trial projects.

Clinical Trial Management Cost Categories

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 (e.g., research coordinators, study coordinators)
  • Other FTE-related expenses:
  1. General, Automobile, and Employment Practices Liability Assessment (GAEL)
  2. Data Network Recharge
  3. Computing and Communication Device Support Services
  4. Central Data Center Services (when applicable)
Applying the Management Direct Fee

When clinical trial management costs are incurred centrally, an internal fee based on percent of total direct costs — or other negotiated/calculated amount — may be assessed as a direct cost charge on industry-sponsored clinical trials.

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.

Departments wishing to charge this fee should:

  • Charge clinical trial management efforts and expenses to a central department project.
  • Credit the central project using Account 54301 to offset expenses.
  • Debit clinical trial projects with the management direct fee using Account 54301.

Note: Regular fiscal oversight (e.g., ledger reconciliation) should not be included in the direct management project.

Department Responsibilities

Departments must establish and implement internal guidelines for managing residual surplus balances or covering shortfalls in the central administrative project.

Departments charging federally sponsored projects for direct management expenses should budget directly for actual staff effort and related expenses, or follow campus guidelines for establishing a recharge activity.

F&A Considerations

The Budget and Resource Management Office will ensure that clinical trial management costs are excluded from the campus F&A rate administrative cost pools.

Therefore, recovering these costs through a management direct fee will not result in duplicate reimbursement from Federal or non-Federal sponsoring agencies.

EMF Update Content Request

Update Content Request