Budgeting for Clinical Trials
Carolyn Strickland, RN, BSN, CCRC
Research Billing Services Consultant
Office of Contracts Management
Objectives
Review basics of a clinical trial
budget
Review “PriceChecker” on
Starbrite
Provide tips on the most common
mistakes we see in OCM
Most Common Budget Mistakes With Budgets for
Industry-Initiated Projects
1) Missing IDS fees
2) Missing IRB fees
3) Lack of knowledge re use of CRC space & fees
4) Accounting for full staff effort
5) VUMC indirect costs
6) Start-up Fee
7) Reimbursement for protocol procedures
8) Annual cost increase for budget items
9) Archive fees
Purpose of a Budget
Understand the cost
Identify who will pay for what
Documentation of cost
Informed decision
Getting Started
Carefully review protocol
Input from investigator, coordinator,
sponsor
Know institutional requirementsfinance, compliance
Price quotes
Developing Budget
List study events and staff time
Identify hidden costs
Account for institutional indirect
-industry sponsored 29%
Identify standard of care (Routine
Care) and research costs
Routine Care
Principle investigator and coordinator must
carefully identify usual and customary care
procedures vs. research specific
procedures
Usual and customary care procedures
would probably be performed if the patient
were not on the study
Routine care tests and results may be
used for research
Research Costs
Research specific procedures would
probably not be performed if the
patient were not on a study
Can not bill insurance for any item
that is reimbursed by sponsor
Schedule of Events example
Screening
-14-- 0 Day
Initiation
Day 1
+/-3Days
MO
1
+/3Days
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+/-3Days
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+/3Days
MO
6
+/3Days
or ET*
Unsched.
visit
STUDY VISIT FLOW CHART
*ET=Early Termination
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Visit 6
Visit 7
Visit 8
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MMT
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MG-ADL
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SF-36
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Assessments
Clinical Exam
Prednisone use HX
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IgA
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IgG
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AchR
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Pregnancy test
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BUN
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Creatinine
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PT/PTT
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CBC/Diff
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LFT
Examinaton of XXXX site
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AE
Con Meds
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Start-up Costs
Protocol review
Staff training
Budget preparation
Site selection/initiation visit
Investigator meetings
Development of study tools
Administration (budget)
Regulatory
Start-up Costs
Nonrefundable
Up front
Average start-up fee $10,000
Fixed Costs
IRB fees- Institutional charge for IRB
review, amendments, annual review
Archive fees
Pharmacy review; set-up fee, annual fee,
close-out fee
External audit fee
Radiology set-up fee
Lab set-up
Close out activities
Personnel costs
Screening
Outreach
Conference calls and email
Patient visits
Study documentation
Regulatory
Data management
SAEs
Monitoring visits
Shipping
Meetings
Study Subject Costs
Assessments- medical history, physical exam,
adverse events
Medical procedures- radiology, cardiology
Professional fees
Office visits/facility fees
Lab work
Medical and/or lab supplies
Hospital bed
VICTR/Clinical Research Center
Screen Failures
Administrative Costs
Office supplies
Telephone or fax charges
Pager
Voicemail
Computer
Postage/Shipping
Payment terms
Critical
Negotiated by the department
Advance payment
Payment trigger
Payment schedule
One time expenses
Payment terms
Prorated payment
Annual cost adjustment
Payment adjustments
Holdback
-Per institution policy holdback can
not exceed 20%
Sponsor Budget
Sponsor Budget
Exhibit B – Clinical Study Financial Terms
$5000
Investigator Fee
$3750
IRB Fee
$5000
Lab Fee
$700
Per patient Fee (estimate 150 patients) estimate $1,050,000
$118,750
Estimated Total (based on 150 patients)
$17,812.50 15 % payable upon IRB Approval (Institution will invoice Sponsor)
$12,963.75 Per month for six months after first patient enrolled. Total $77,782.50
$23,155.00 At close out based on 150 patients
Institution will invoice Sponsor in writing
Any patients over 150 forecasted billed at $700 /per patient
Any patients under 150 deducted at $700/per patient
IRB amendments and continuing reviews will be an invoiceable pass-through cost at $500 each
amendment, $750 each continuing review.
All payments made pursuant to this Agreement shall be made payable to Vanderbilt University Medical
Center and directed to the following address:
Attn: Stephen Todd
Associate Director
Department of Finance
Academic and Research Enterprise
Vanderbilt University Medical Center
Dept AT 40303
Atlanta, GA 31192-0303
Each payment voucher should reflect IMI’s name, Protocol Number, and the Principal Investigator’s
name. Institution’s Federal Tax Identification Number is____62-0476822_______.
Negotiation
Budget process requires negotiation
Documentation
Confidence
Ideal vs. bottom line
Compromise
Mutual agreement
Example of Price Checker Screen – Basic Instructions
Example of Price Checker Screen – Discounts/Rates
Example of Price Checker Screen
Most Common Budget Mistakes With
Budgets for Industry-Initiated Projects
1) Missing IDS fees – 4 fees including: Initial submission -
~$2000-$3000; Annual fee - ~$1650 (varies); Close-out ~$650; Dispensation of drug – varies. Always get an
IDS quote.
2) Missing IRB fees – 3 fees including: Initial submission $2250; Amendments each $500; Continuing Review $750.
3) Lack of knowledge re use of CRC space & fees
4) Accounting for full staff effort
5) A misunderstanding or lack of knowledge re VUMC
indirect costs
(continued next slide)
Most Common Budget Mistakes With Budgets
for Industry-Initiated Projects (continued)
6) Failure to obtain Start-up Fee
7) Inadequate or no reimbursement for protocol
procedures; use tools such as Price-Checker; i.e.
pathology fees for tissue samples
8) Failure to build in annual cost increase for budget items
9) Archive fees
Questions?
Contact for Budget
Assistance
Carolyn Strickland, RN, BSN
Research Billing Services Consultant
Office of Contracts Management
936-6691
carolyn.strickland@vanderbilt.edu