How to Build a Budget

Wendi R. Mason, NPInterstitial Lung Disease Program Coordinator

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

Getting Started

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?”

Getting Started: Be Organized Create a list of common billing itemsCPT Code CDM Descriptor Cost D&H_______

94720 28010031 Diffusing capacity $317.00 $136.00

94240 28010056 TLC $389.00 $124.48

94060 28010098 pre-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

Getting Started: Be Organized

The Budget

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

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.

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

The Budget: Don’t forget!

Annual Fees IRB fees Pharmacy fees

Patient reimbursements Additional Supplies

Equipment, supplies Screen failures

The Budget

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

VICTr Vanderbilt Research: Institute for Clinical and

Translational Research Websites:

https://starbrite.vanderbilt.edu/funding/ https://starbrite.vanderbilt.edu/

Funding Clinics: Every Monday 10 am to 11 am CRC Conference Room A-3210 MCN

VICTr

VICTr

VICTr

What happens when you don’t ask…

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?”

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

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.

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.

Budget Building Made Easy

FACTr 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 16, 9am, Crystal Terrace http://vanderbilt.mzinga.com/app/servlet/goTo?

DirectLinkID=78797&Page=CourseInfo

FACTr

FACTr

FACTr

FACTr

FACTr

FACTr

FACTr

FACTr

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

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 attentionwendi.mason@vanderbilt.edu

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