Key Questions to think about:
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.