****Industry Sponsored**** 

Clinical Study Subject:

Clinical Activities
Obtain research and regular rates for:
_______ Each clinical procedure
_______ Out-patient clinic room
_______ Laboratory fees
_______ Central lab
_______ Overnight shipping
_______ Pharmacy charges
_______ In patient room
_______ Radiology

Personnel     
Estimate number of hours or give fee:
_______ Physician
_______ Coordinator
_______ Technical
_______ Clerical

Subject Payment  
Define amounts and times for:
_______ Per visit stipends
_______ Travel
_______ Meals
 _______Parking

Administrative costs           
 Obtain rates and/or amounts for:
_______Indirect cost
_______Other overhead

Study Budget Checklist:

SUBJECT Costs
_______ Cost per subject                     x  Maximum number of subjects
_______ Cost per screened subject   x  Maximum number of screened, but not enrolled
_______ Cost per dropped subject     x  Maximum number of dropped subjects
_______ Bonus
Number of subjects qualifying

STUDY Charges Up Front Costs
_______ IRB Preparation fee ($1,000)
_______ Capital equipment (include cost of maintenance if applicable)
_______ Sub-contracts
_______ Record storage charges
_______ Informed consent form translation 
_______ Advertisement(s)
_______ Special supplies
_______ Training costs
_______ Source document preparation

MANAGEMENT Charges
_______ Pharmacy charges (storage and preparation of drug)
_______ Monitor visits (Coordinator time)
_______ Post-study Coordinator charges
_______ Protocol amendments
_______ Physician fee (Salary and benefits)
_______ Coordinator fee (Salary and benefits)
_______ Administrative Assistant fee
_______ Technical fee
_______ Research Administrator
_______ SAE Processing
_______ Annual CHR review ($200/year)

ADMINISTRATIVE Charges
_______ Indirect costs on Study charges _______________%
_______ Cancellation fee