1. How to Build a Budget Wendi R. Mason, NP Interstitial Lung Disease Program Coordinator

2. Objectives By the end of this discussion, participants will realize the importance of recognizing all aspects of a study budget. know who to contact with particular questions learn some organizational tools for creating future budgets recognize the importance of work associated with a study and include that time as a cost in your budget know the order of events to contract/budget approval have been introduced to FACTR

3. Getting Started

4. Mr. Industry says, “We’re very excited for you to join our study and our team. When can you get this submitted to your IRB?”

5. Getting Started: Be Organized Create a list of common billing items CPT Code CDMDescriptorCost D&H_______ 94720 28010031Diffusing capacity$317.00 $136.00 94240 28010056TLC$389.00 $124.48 94060 28010098pre-post bronchodilator$622.00 $199.04 Update this regularly!! Prices change several times over the year! Include in this list those items that occur that you may not see in a Schedule of Events.  Creation of HRCT de-identified disks  Fees to Pathology for reading slides / completing paperwork

6. Getting Started: Be Organized

7. The Budget “Here is our budget. When can you submit the protocol to your IRB?”

8. The Budget: D&H vs. Direct Cost Compare:  How much will this cost me directly? and  How much are they paying? Determine how much the study would cost if you were billing each item as Standard of Care.

10. The Budget Include a line item for your time Include professional fees for everything Include CRC  Nursing, facility Longitudinal studies  Build in a price increase Overhead/Indirects  29% institution; 5% division

11. The Budget: Don’t forget! Annual Fees  IRB fees  Pharmacy fees Patient reimbursements Additional Supplies  Equipment, supplies Screen failures

12. The Budget

13. Discuss Study with Sponsor How much will be expected by the coordinator  Number of patients expected to enroll (increased patients amplifies the responsibilities of the coordinator)  CRFs – paper/web-based; difficulty level; how much data is captured for specific tests  CRF completion within x days of visit  Collection of outside specimens (such as biopsies, disks, records)  Patient reimbursement or compensation  Frequency of monitoring visits  DCF turn around  Obtaining wet signatures of PI on every item  Protocol – Consent form changes (IRB submissions!) Sub-study involvement Acceptance of electronic record/source documentation

14. VICTr Vanderbilt Research: Institute for Clinical and Translational Research Websites:  http://www.mc.vanderbilt.edu/victr/pub/ http://www.mc.vanderbilt.edu/victr/pub/  https://starbrite.vanderbilt.edu/ https://starbrite.vanderbilt.edu/ Funding Clinics:  Every Monday  10 am to 11 am  CRC Conference Room A-3210 MCN

15. VICTr

18. What happens when you don’t ask…

19. Discuss with Sponsor’s Budget Agent This is usually a different person than the “Study Start Up” group. Ask for the most that you believe that you can get. Keep a documentation trail. “So we’ve agreed on a budget…. When can you submit this to your IRB?”

20. Submit to your Department Check with your Department  If required, electronically submit your agreed budget amount Contract Protocol Informed Consent (if you have it completed) Continue to communicate with your Department and the Sponsor’s Contract Agent

21. Department’s Responsibilities Completion of several internal budget forms, request center number, obtain signatures, create and submit a transmittal form to Grants and Contracts This may take several weeks.

22. Grants and Contracts The Department submits to G&C where it is logged in, given a contract number, and assigned a Contract Analyst. Continue to communicate.

24. Budget Building Made Easy FACTr  https://webapp.mis.vanderbilt.edu/factr/home.jsp https://webapp.mis.vanderbilt.edu/factr/home.jsp  A web-based system for all budget-related needs D&H requests Center number requests Grant submissions Budget building  Training Classes – March 22, 9am, Crystal Terrace http://vanderbilt.mzinga.com/app/servlet/goTo?Page=Co urseInfo&DirectLinkID=78797 http://vanderbilt.mzinga.com/app/servlet/goTo?Page=Co urseInfo&DirectLinkID=78797

25. FACTr

33. Resources Your Department Administrator  Know this person! Dept of Finance (prefer email)  Dianne McGrath (Contracts) 2-4549  Theresa Shalaby (research rates [through FACTr]) 2-0200  Cara Baughman (StarPanel forms, FACTr questions) 6-2641  Sandy Greeno (Grants, billing issues) 3-3653 Grants and Contracts  Janet Fry 6-5886  Carolyn Strickland (Contracts) 6-6691

34. The Budget after Study Start-Up Further discussion and just as important! Accounting for your Center number Watching patient billing charges Watching professional fees Thank you for your time and attention wendi.mason@vanderbilt.edu 3-7068