1. Wendi R. Mason, NP Interstitial Lung Disease Program Coordinator
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. Getting Started
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?”
Industry is quick to send you a protocol and say – get this to the IRB – when can you start…
- tell them you need the contract and the budget. Do nothing until you see a budget. Work through their budget and agree on something.
Industry will give you a budget – usually much less than what you are worth. It may be based on what other places within VU have charged – it may be a study-wide budget. Ask for more. You may not get what you ask for, but you will certainly get more than you would have origianally.
Typically the person who does the budget is not the person who is trying to get your IRB approved.

5. Getting Started: Be Organized
Create a list of common billing items
CPT Code CDM Descriptor Cost D&H_______
Diffusing capacity $ $136.00
TLC $ $124.48
pre-post bronchodilator $ $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
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.

9. Here is a budget I built back in 2006. BUILD 3
This is another spreadsheet that I create for each study. Explain the columns
- standard of care – can’t charge more than this
- middle column - what the sponsor is willing to pay
- last column – absolute lowest I can go
I don’t give this to the sponsor because they don’t need to see the D&H column.

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
IRB charges – they charge for just about everything. ID Pharm has a Opening cost, annual cost, close out cost, in addition to the dispensing cost. Supplies may include binders, disks for CT downloads, freezer. Some devices or equipment are expected to be at your site – you might be expecting them to provide these things – if it is not included in the contract, you’ll be paying for it.
$ 200 for creating HRCT disk
Those familiar with the Dept of Finance Quick Look Up – don’t use it, not up to date

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
CRFs – If you can get a copy of the CRFs (even if Draft) get one!!
Data capture – are they asking for one value on a PFT (FVC) or are they collecting the whole study; what criteria are they collecting on medications (start dates, mg, dose, etc), difficulty of SAE forms, concom meds, diaries, questionnaires, amounts of labs.
Mailing – are they using Fed Ex for everything – how easy is it for you to get an envelope to Fed EX?

14. VICTr
Vanderbilt Research: Institute for Clinical and Translational Research
Websites:
Funding Clinics:
Every Monday
10 am to 11 am
CRC Conference Room A-3210 MCN

15. VICTr

16. VICTr

17. 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?”
These people are savvy and have likely worked with several studies at Vanderbilt (if a large company).
Sometime you go back and forth until you agree on a price. Sometimes you don’t.
If you can’t get enough money out of them to cover your costs, your study won’t happen. If you don’t tell them how much money you need to cover your costs, your salary and benefits, they aren’t going to know!

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
to your Departments’ Grants Manager or Admin Officer.

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.
Our Department’s contact person is very good… but evenso, I like to contact him weekly to find out how my study is going through the process.

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.

23. Be a part of the contract debates – ensure that your budget does not change! It will. Carefully look at the responsibilities that are built into this contract that affect your budget. Watch for changes!
Contract approvals take several weeks – months.
When I turn my paperwork over to my Department I begin my IRB work. Our IRB has improved it’s process dramatically – now I get IRB approval weeks before contract approval.

24. Budget Building Made Easy
FACTr
A web-based system for all budget-related needs
D&H requests
Center number requests
Grant submissions
Budget building
Training Classes – March 16, 9am, Crystal Terrace
FACTr
Financial Accountability and Compliance Tracking for Research
Classes are about every two weeks.

25. FACTr

26. FACTr

27. FACTr

28. FACTr

29. FACTr

30. FACTr

31. FACTr

32. FACTr Fill in all blanks – this pulls from the Charge Master
You may need to try to name it a few times…
After you have completed full document you will see the D&H amount.

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

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
3-7068
Another day…