Budgetary issues are at the heart of successful clinical trial conduct. Inadequate budgeting results in hardships at the site level that compromise both recruitment and trial success. In addition, under budgeting can be seen as a sign of lack of expertise and can undermine credibility in the conduct of research. This session will discuss budget preparation in a frank and straight forward manner using example clinical trial protocols to demonstrate items (both listed and omitted) that need to be included in calculating a representative cost budget. The participants will discuss issues within the protocol and what impact they will have upon the final budget. Generic clinical trial protocols will be examined over the course of the presentation. This session will help to define clinical trial budgetary requirements, to illustrate time, cost and procedural breakdown using protocol as the template, and to demonstrate useful budget negotiation techniques.