There are several parameters that should be taken into account in order to develop an accurate budget.
Per patient budget: Time and effort items are budgeted using hourly rates for the physician, nurse, and/or study coordinator. Many sites pick average physician, nurse, and coordinator hourly rates to use for budgeting. It is also important to make sure that items with CPT codes are accurately budgeted. These costs typically come from a chargemaster or Medicare rates. If a rate cannot be found in the chargemaster or through Medicare, then it is important to obtain a cost quote for the item/service.
Administrative Fees: There are several administrative fees that can be included in a budget. At a minimum, every budget should include a start-up fee, an annual renewal fee, and a close-out fee. These three fees cover periods of the study where there is a heavy administrative burden on the site. The amount charged for these fees will vary by site and site structure. Be able to provide documentation and breakdown of how these fees were calculated. Many sponsors will request this information. If this information is not available, it is unlikely that the sponsor will pay the full amount.
