The Clinical Trials Office provides budget development and sponsor negotiation services for all investigators. During the budget development process, the budget analyst will first create the coverage analysis which is a document that outlines which clinical procedures may be paid by Medicare or health insurance, and which procedures must be paid by the study sponsor. Then the Clinical Trials Office will work with the research team, sponsor, and any applicable affiliates to identify all of the direct costs of the study. The CTO will then negotiate the proposed budget with the sponsor and come to an agreement on the total cost of the study. Once negotiations have completed, the assigned budget analyst from the Clinical Trials Office will obtain final budget approval from the research team.
Important budgetary items to consider
- Personnel Expenses
- Salary for investigators, study coordinators, and any other personnel involved in a particular study
- Study Procedures, Equipment, and Supplies
- The costs associated with the actual study procedures themselves as well as any necessary equipment and supplies to conduct the study.
- Clinical Service Fees
- Fees associated with conducting clinical research at our institution as well as any affiliate services utilized
- Radiology Start-Up
- Laboratory Start-Up
- Pharmacy Start-Up
- Institutional Review Fees
- UH Start-Up Fees
- IRB Fees
- Subject Compensation
- Costs associated with compensating patients and/or caregivers for their involvement in a study
- Use the Participant Payment Form to develop the payment schedule
- Payment Terms and Conditions
- Unscheduled Visit Compensation
- Screen Failure Compensation
- Overhead
- Payment Frequency
- Withholding
- Method of Payment