1. Budget Workbook Office of Clinical and Translational Research OCTR

2. Office of Clinical & Translational Research, OCTR  The office is under Peter Albertsen, MD, Associate Dean of Clinical Research Planning and Administration

3. Office of Clinical and Translational Research Judi Kulko Executive Administrator Judy Kulakofsky Budget Workbook Financial Compliance Auditing Judi Gilson Industry Contracts Judie Fine “The Guide” Clinical Trials.gov Clint Propfe FRS account Set up and close Out & Reconciliation

4. What is the Budget Workbook?  A tool used by the OCTR (Office of Clinical and Translational Research), with input by the P.I., the Study Coordinator, and the Department Administrator to develop an accurate clinical trial budget.  Identifies all of the charges associated with the study. Charges are defined as:  RC, Routine Clinical Services (incurred as part of patient’s standard care, which are paid by Medicaid, Medicare, Private Insurance, or patient), or  PIC, Protocol Induced Costs (charges incurred as a result of the research which are usually paid by the Research Sponsor).

5. What is the Budget Workbook?  Charges can be paid by only one payer.  Ensures Research Financial Compliance, so that there’s no inadvertent “double- dipping.”  It keeps us out of trouble!

6. How do we start?  The PI, Study Coordinator, or Department Administrator sends OCTR the protocol, the Informed Consent Form and the sponsor's budget.  The Preliminary Workbook Packet is completed by the P.I. and Study Coordinator and sent to OCTR.  The Packet tells OCTR who’s doing what and where it’s happening.  Charges are determined to be paid by insurance or by research.  The packet is available on- line under the Forms tab at http://octr.uchc.edu http://octr.uchc.edu

7. What does the Budget Workbook tell us?  Tells us how much the study will cost  Identifies who is responsible for paying  The payer will be one of the following:  Private Insurance  Medicare  Medicaid  The patient, if there is no insurance  The Research Sponsor  Identifies the time and effort required of each member of the study team.

8. Is one Budget Workbook just like another? It all depends on the who’s paying….  Federal  Foundation  Industry  Institution

9. Applying Discount Rates  Different studies receive different research discount rates UMG discount for ALL clinical trials: 20% from standard fee JDH discount for Industry sponsored studies: 20% from the standard fee JDH discount for “other” clinical trials: 45% from the standard fee (includes Foundation supported studies and non-Federal, Investigator-initiated studies.) Federal (NIH, NCI): discount negotiated annually See Tab 13 of the Guide on line for rates http://octr.uchc.edu

10. Applying F&A Rates  Different sponsors are charged different IDC (Indirect Costs) rates, also called F & A (facilities and administration) rates  Federal: 53%  All Other: 25% unless specifically stated otherwise in the contract

11. When do we do the Budget Workbook?  Should be done up front Before a grant is submitted Before applying to a foundation for funding Must be done before a protocol is submitted to the IRB (Institutional Review Board) for approval Allow five days for a budget workbook to be completed.

12. Why do a Budget Workbook?  Budget workbook was developed to Standardize the research budget process  Provides mechanism to assure research financial compliance in all clinical trials  Provides accurate costs for doing clinical trial at UCHC  Assists the person paying the bills in identifying what should be billed to the Research Sponsor v. what should be billed to Insurance

13. Office of Clinical and Translational Research (OCTR)  Judi Kulko, Executive Administrator kulko@uchc.edukulko@uchc.edu 860.679.1395  Judy Kulakofsky, Coordinator Budgets and Budget Workbooks kulakofsky@uchc.edukulakofsky@uchc.edu 860.679.7816  Judi Gilson, Coordinator Industry Contracts gilson@ADP.uchc.edu 860.679.2742 gilson@ADP.uchc.edu  Judie Fine, Coordinator Guide, Clinicaltrials.gov fine@NSO.uchc.edufine@NSO.uchc.edu 860.679.3366  Clint Propfe, Reimbursement Analyst propfe@uchc.edupropfe@uchc.edu 860.679.4369 http://octr.uchc.edu