Whether an investigator-initiated protocol or one that is industry sponsored, one of the key factors to a study’s success is its budget, including a finalized contract with the sponsor.
Key Questions to think about:
- Identify all activities in the study that will have a cost, including time. This can be the most difficult part of the budget to calculate, but is crucial.
- Submit to the UAB Office of Clinical Billing Review for review to confirm whether specific costs in the study that might be billed to insurance. Additionally, the FAP review will confirm the basic UAB costs.
Look closely at the protocol to identify all costs:
- List all assessments and tests, and their frequency. Document how much time each assessment and test will take. This will help you calculate how much personnel time, salary and support will be needed.
- Consider if subject reimbursements will be needed.
- If an investigator-initiated study, funds may be needed for the statistician and database development. Also consider lab supplies, central lab fees, shipping (if necessary), cost of study drug, time for report generation and document management.
For a detailed description of the budget and contract process at UAB please refer to the Clinical Protocol Activation Process, or CPAP, which can be viewed or downloaded here as a PDF.