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It is the policy of the University to charge industry sponsors for all direct and indirect costs incurred in the conduct of industry-supported clinical trials. All potential sponsors of clinical trial programs must be informed of this policy before beginning negotiation of research project budgets that will be included in the research contract. It is best to receive help with your budget development or have your budget reviewed by your schools Office of Sponsored Research. The information below is simply a guideline to support your work. Sponsor may provide a budget Sponsor budget may not identify all of the cost of the trial at our institution Sponsor budget may not reflect charges or annual inflation increase at our institution Institutions can request a nonrefundable startup fee. Fees can range from $5,000 to $15,000; avg. $10,000 depending on size of trial. A Professional fee is a charge for the professional services performed by a physician, such as completing a physical examination or interpreting an ECG. The professional fee is may be billed by the physician’s office. A Technical or Facility fee is a charge for services performed by the hospital, such as diagnostic tests, or radiology procedures. This fee covers the use of the Hospital’s facility, its personnel and equipment A Global fee is sometimes charged by departments, such as Pathology, when physician performs both the professional and technical service. INDUSTRY SPONSORED CLINICAL STUDY SUBJECT BUDGET CHECKLIST STUDY Charges Up Front Costs _______ Protocol review and feasibility review: professional fee PI/study coordinator _______ IRB Submission fee _______ Site selection and Site initiation visit: PI/Study Coordinator time _______ Capital equipment (include cost of maintenance if applicable) _______ Sub-contracts _______ Special supplies _______ Training costs _______ Source document preparation _______ Personnel time for screening patient _______ Pharmacy Set-up Fee (Fixed fee) _______ Radiology Set-up Fee (If any, Fixed fee) Clinical Activities _______ Each Procedure costs (vital signs, EKG, PET, MRI, X-rays, etc) Professional and facility component _______ Each Assessment costs (neurological, psychological, and physical exams Professional and Facility Component) _______ Outpatient clinic room _______ Inpatient room costs _______ Laboratory fees/Specimen Processing/Central Lab or outsourced Lab _______ Overnight shipping _______ Radiology charges _______ Phlebotomy charges _______ Copy cost for X-rays, MRIs etc. _______ Pharmacy charges (storage, preparation or dispensation of drug) _______ Investigational (Drug fee, if any) _______ Fee for Clinical Research Center Personnel Fees Estimate number of hours per patient or patient visit or, if appropriate, for project as a whole. Personnel Salary estimates should include salary, benefits, and an appropriate annual increase over the expected number of years of the study. _______ Physician _______ Coordinator _______ Technical _______ Clerical _______ Other Subject _______ Cost per subject _______ Cost per screened subject enrolled _______ Cost per dropped subject _______ Bonus Define amounts and times for: ______ Per visit stipends _______ Travel _______ Meals _______Parking x x Maximum number of subjects Maximum number of screened, but not x x Maximum number of dropped subjects Number of subjects qualifying MANAGEMENT or OTHER Charges _______ Monitor visits (Coordinator time) _______ Recruitment Advertisement(s) _______ Record storage charges _______ Post-study Coordinator charges _______ Close-out activities (Personnel time/Fixed cost) _______ Protocol amendments: Personnel Time _______ SAE Processing _______ Biostatistical or other analytical costs _______ Data Management _______ Equipment maintenance _______ WIRB fees when changes in protocols require additional fees _______ Dry ice/shipping costs/fax and phone costs _______ Laboratory and specialized equipment supplies _______ Computers _______ Telephone and Fax charges Administrative costs Obtain rates and/or amounts for. _______Indirect cost _______Other overhead