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 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 x Number of subjects qualifying
Define amounts and times for:
______Per visit stipends
______Travel
______Meals
______Parking
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