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Budgeting for Clinical Trials Carolyn Strickland, RN, BSN, CCRC Research Billing Services Consultant Office of Contracts Management.

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Presentation on theme: "Budgeting for Clinical Trials Carolyn Strickland, RN, BSN, CCRC Research Billing Services Consultant Office of Contracts Management."— Presentation transcript:

1 Budgeting for Clinical Trials Carolyn Strickland, RN, BSN, CCRC Research Billing Services Consultant Office of Contracts Management

2 Objectives Review basics of a clinical trial budget Review PriceChecker on Starbrite Provide tips on the most common mistakes we see in OCM

3 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

4 Purpose of a Budget Understand the cost Identify who will pay for what Documentation of cost Informed decision

5 Getting Started Carefully review protocol Input from investigator, coordinator, sponsor Know institutional requirements- finance, compliance Price quotes

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

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

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 -14-- 0 Day Initiation Day 1 +/-3Days +/-3Days MO 1 +/- 3Days MO 2 +/- 3Days MO 3 +/- 3Days MO 4 +/-3Days MO 5 +/- 3Days MO 6 +/- 3Days or ET* Unsched. visit Visit 1Visit 2Visit 3Visit 4Visit 5Visit 6Visit 7Visit 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

11 Start-up Costs Nonrefundable Up front Average start-up fee $10,000

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

13 Personnel costs ScreeningOutreach Conference calls and email Patient visits Study documentation Regulatory Data management SAEs Monitoring visits ShippingMeetings

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

15 Administrative Costs Office supplies Telephone or fax charges PagerVoicemailComputerPostage/Shipping

16 Payment terms Critical Negotiated by the department Advance payment Payment trigger Payment schedule One time expenses

17 Payment terms Prorated payment Annual cost adjustment Payment adjustments Holdback -Per institution policy holdback can not exceed 20%

18 Sponsor Budget

19 Exhibit B – Clinical Study Financial Terms $5000Investigator Fee $3750IRB Fee $5000Lab Fee $700Per patient Fee (estimate 150 patients) estimate $1,050,000 $118,750Estimated Total (based on 150 patients) $17,812.5015 % payable upon IRB Approval (Institution will invoice Sponsor) $12,963.75 Per month for six months after first patient enrolled. Total $77,782.50 $23,155.00At 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 IMIs name, Protocol Number, and the Principal Investigators name. Institutions Federal Tax Identification Number is____62-0476822_______.

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

21

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 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)

26 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

27 Questions ?

28 Contact for Budget Assistance Carolyn Strickland, RN, BSN Research Billing Services Consultant Office of Contracts Management 936-6691 carolyn.strickland@vanderbilt.edu carolyn.strickland@vanderbilt.edu


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