When preparing the budget for a clinical trial, it needs to be flexible. If the trial goes over-budget, the sponsor must cover the cost. Budget items can be categorized in one of two ways: 1) fixed and upfront costs which are needed for study conduct and are incurred whether or not a subject is enrolled and 2) costs related to subject visits. In addition to budgeting for the study itself, the institute where the study is taking place needs to be budgeted for as well. Some factors here that need to be considered are what institutional approvals are needed and whether or not there are mandated fees charged.