All means of transportation (apart from personally owned car), and lodging
If a participant management platform is available through your trial for participants to book their travel and concierge services: Direct Payment through platform
No out of pocket expense to participant - cover directly through sponsor funding
Requires documentation
Meals and Incidental Expenses
All meals during travel and treatment days (including reasonable and customary tips)
Reimbursements paid in arrears with documentation.
Prepayment is allowed within the constraints mentioned above
Requires documentation
Vehicle- Related Expenses
Mileage, Parking
Reimbursement or Prepayment (in accordance with the current IRS mileage reimbursement rate)
Requires documentation
Dependent Care Expenses
Includes childcare and eldercare expenses when trial-related
Stipends
Includes hand-written receipts where appropriate
Technology Expenses
Includes WiFi, cellular services etc. for trial related needs
Reimbursement
Requires documentation
Other Need-Based Expenses
Can include other trial-related expense, such as lost wages
Need-Based Stipend
It should be communicated to participants that these payments are considered taxable income and may be declined if desired.
Study Related Activities
Study-specific activities that participants are required to complete for the study (e.g., ePRO entries)
Study Activities and Requirements
It should be communicated to participants that these payments are considered taxable income and may be declined if desired.
When structuring clinical trial budgets, research teams should:
Clearly define each payment type to prevent financial confusion for participants.
Prioritize reimbursements and prepayments over taxable stipends.
Communicate tax implications transparently to all participants.
Engage IRBs early to ensure compliance and alignment with ethical guidelines.
By adopting a standardized participant payment model, sponsors and CROs can:
Improve trial accessibility by reducing financial burdens—a need clearly reflected in our Cost of Clinical Trial Participation Survey, which highlights the significant out-of-pocket costs many participants face.
Improve the obtainable size of the recruitable patient population by allowing lower income populations (which include a high percentage of participants from underrepresented groups) to participate.
Increase the quality of product development process by improving the diversity among the enrolled patient population.
Simplify budget creation and allocation by introducing process clarity and standardization.
Increase participant retention, reducing the overall cost to execute the study.
