Because a clinical trial contract is a fixed-price agreement, you are obligated to perform the work described in the contract, even if your actual costs exceed the total contracted amount. Also, in most cases you receive payment as milestones. Often costs are incurred costs without reaching a milestone. Therefore, a clinical trials budget focuses more on the milestones. A standard budget format can be found on the SPA website.

In developing the clinical trial budget, you should estimate the number of patients that may be enrolled in the study and multiply that by the milestone payments of each patient. This will estimate the revenue planned for the study. Then, estimate the expenditure budget based on the overall costs of delivering the study. Most clinical trial agreements provide for number of payments associated with the start-up of the study. These costs are normally; 1) an IRB fee, 2) a pharmacy set-up fee, 3) a CTO fee, etc. This process ensures that regardless of the patient enrollment, WSU will receive reimbursement for costs it did incur.