Download List of cost considerations for building a budget - Rutgers

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.
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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