1. Budgeting for Clinical Trials
Carolyn Strickland, RN, BSN, CCRC
Research Billing Services Consultant
Office of Contracts Management
My Biosketch
Basic overview of budget negotiation
Informal, Interactive, ask questions
Review budget development, review examples
Available after session for off topic questions

2. Objectives Review basics of a clinical trial budget
Review “PriceChecker” on Starbrite
Provide tips on the most common mistakes we see in OCM
Just review don’t discuss

3. Lack of knowledge re use of CRC space & fees
Most Common Budget Mistakes With Budgets for Industry-Initiated Projects
Missing IDS fees
Missing IRB fees
Lack of knowledge re use of CRC space & fees
Accounting for full staff effort
VUMC indirect costs
Start-up Fee
Reimbursement for protocol procedures
Annual cost increase for budget items
Archive fees

4. Purpose of a Budget Understand the cost Identify who will pay for what
Documentation of cost
Informed decision
How much will the study cost?
Who will pay for each procedure and staff effort? Insurance, the sponsor,
Good documentation assists with negotiation and decreases delays
Should you open this trial?

5. Getting Started Carefully review protocol
Input from investigator, coordinator, sponsor
Know institutional requirements- finance, compliance
Price quotes
Feasible?
Staff- Need additional staff? Training?
Reasonable? Will patients with memory loss have to complete a daily electronic diary entry? Are blood draws daily over several hours for many days? Is the pt NPO for an extended period? Is the data due within 24 hrs of visit?
Compatible? Conflict with other studies- compete? Is it in line with work department is already doing? Some dept have a committee to review research studies
Do you see these pts in your clinic? Competitive enrollment
Get price quotes and estimate cost of staff
Dept of Hospital Finance Billing Compliance - researchratesrus

6. 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
Events should mimic x-page
Reconcile x-page with protocol, lab manual, CRFs

7. 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
Usual and customary or SOC is unique to the institution.
Ask the question- would I perform this procedure/service if the subject were not on a study? Is it reimbursable?
Physician must assist and agree- physician word most important during an audit or court case.
Medicare- is trial eligible? Is item eligible? LMRP site- Star panel- “Inf resources” CPT & ICD-9 check compliance-
Third party payor

8. 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

9. Schedule of Events example
Screening
Day
Initiation
Day 1
+/-3Days MO 1 2 3 4 5 6
+/-3Days or ET*
Unsched.
visit
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Visit 6
Visit 7
Visit 8
XXXX-STUDY
Assessments
Clinical Exam √
Prednisone use HX MM
MMT
QMG
MG-ADL
SF-36
IgA
IgG
AchR
Pregnancy test
BUN
Creatinine
PT/PTT
CBC/Diff
LFT
Examinaton of XXXX site
√ (Teach)
√ (Refresher Course) AE
Con Meds
STUDY VISIT FLOW CHART
*ET=Early Termination

10. Start-up Costs Protocol review Staff training Budget preparation
Site selection/initiation visit
Investigator meetings
Development of study tools
Administration (budget)
Regulatory
Also known as the site initiation costs/fee- incurred before the first patient is enrolled
Tools- data collection and patient education
Staff time for meetings
File set up and internal paperwork

11. Start-up Costs Nonrefundable Up front Average start-up fee $10,000
National Conference range- $5,000- $15,000
Local fee standard $7500

12. 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
Pass through fees
Line item
Don’t forget to add 29% indirect
May be a one time fee

13. Personnel costs Screening Outreach Conference calls and email
Patient visits
Study documentation
Regulatory
Data management
SAEs
Monitoring visits
Shipping
Meetings
Staff effort

14. 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
Research discounts
Many procedures have professional fees- EKG, CXR, Cat scan

15. Administrative Costs Office supplies Telephone or fax charges Pager
Voic
Computer
Postage/Shipping
Department overhead not covered in the 29% indirect
Get Sponsor billing number for shipping

16. Payment terms Critical Negotiated by the department Advance payment
Payment trigger
Payment schedule
One time expenses
Designed to assist with cash flow.
Advance should be paid upon contract execution; pt advance is credited towards future payment. 20% or 2 pts
Trigger- CRF completion? Monitor visit and pulled data?
Quarterly or less
Milestones may be ok if payment still made quarterly and prorated for pts enrolled
One time- remittance within 30 days or with next quarterly payment

17. Payment terms Prorated payment Annual cost adjustment
Payment adjustments
Holdback
-Per institution policy holdback can not exceed 20%
Annual cost adjustment- 5-10%
Ask for more money if needed

18. Sponsor Budget

19. 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, % payable upon IRB Approval (Institution will invoice Sponsor) $12, Per month for six months after first patient enrolled. Total $77, $23, 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 Atlanta, GA Each payment voucher should reflect IMI’s name, Protocol Number, and the Principal Investigator’s name. Institution’s Federal Tax Identification Number is____ _______.

20. Negotiation Budget process requires negotiation Documentation
Confidence
Ideal vs. bottom line
Compromise
Mutual agreement

22. Example of Price Checker Screen – Basic Instructions

23. Example of Price Checker Screen – Discounts/Rates

24. Example of Price Checker Screen

25. Most Common Budget Mistakes With Budgets for Industry-Initiated Projects
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.
Missing IRB fees – 3 fees including: Initial submission - $2250; Amendments each $500; Continuing Review - $750.
Lack of knowledge re use of CRC space & fees
Accounting for full staff effort
A misunderstanding or lack of knowledge re VUMC indirect costs
(continued next slide)

26. Most Common Budget Mistakes With Budgets for Industry-Initiated Projects (continued)
Failure to obtain Start-up Fee
Inadequate or no reimbursement for protocol procedures; use tools such as Price-Checker; i.e. pathology fees for tissue samples
Failure to build in annual cost increase for budget items
Archive fees

27. Questions?

28. Contact for Budget Assistance
Carolyn Strickland, RN, BSN
Research Billing Services Consultant
Office of Contracts Management