ABSTRACT
Clinical trials cannot be conducted without adequate funding. When considering a study, one of the first steps the study manager or appropriate budget staff must take is to determine if it is financially feasible for the site to conduct the study. Study budgets are complex and require analysis of the protocol, the clinical trial agreement (CTA), the informed consent, and an understanding of the regulations of the Affordable Healthcare Act that impact research costs. In addition, information on the cost of the study procedures, staff salaries including benefits, contractors, and facility and administration fees (overhead) is needed. This chapter covers the following budget steps: (1) identifying study costs to determine financial feasibility of the study, (2) budget development, (3) billing, (4) negotiating the budget, and (5) the payment plan.
