Investigators often review budgets within the scope of categories presented in the actual budget worksheet, failing to recognize "hidden" or "missing" costs which may not be captured on a "per visit" or "per patient" scenario. A careful feasibility assessment will quickly identify any hidden or missing costs which should be considered before accepting any proposed budget.

The following costs are frequently forgotten in many study budgets:
• Site-specific fees (for research/regulatory review services)
• Annual adjustments for increases to site procedure rates
• Shipping fees for drug or device return
• Storage fees for data records
• Start up fees to cover staff time on IRB and contract preparation and submission processes
• Pharmacy fees (initial and renewal)
• IRB fees (amendment and renewal)

The following items may be helpful in developing a realistic study budget:

• Start Up Payment Acknowledgement Letter to Sponsor (PDF) For Start Up Costs (ULink id login required)