Budget Development

1. Budget Development Presented by: Jean Mercer Associate Director for Clinical Research Administration Office of Clinical Research – School of Medicine

2. Topics that will be covered • Systems for budget development. • Identifying items to budget. • Standard of care items. • Identifying pricing information.

3. More Topics • Indirect costs • Start up expenses • Screen failures • Budget feasibility

4. Systems for Budget Development • Study Manager • Contact Karen Best (8-5850) for training • Excel Spreadsheet

5. How do I identify what items I need to budget? • Review the Schedule of Activities spreadsheet in the protocol. • Review the Study Procedures section of the protocol.

6. Identifying Items to Budget • Review the budget exhibit or section of the contract agreement. • Talk with the Research Coordinator (if applicable) who will be involved with the study.

7. What about Standard of Care Items? • As you review the protocol look to see what tests and procedures may be considered Standard of Care for the patient population involved in the study. • Identify these items as SOC on your budget spreadsheet.

8. How do I find the cost information for procedures/tests? • Contact the appropriate area to obtain pricing information. (See contact list) • Use Study Manager to obtain pricing information for Clarian procedures.

9. Indirect Costs • Do I really have to include these? (Yes ) • The current indirect cost rate for an industrially sponsored clinical research trial is 25%. • The current indirect cost rate for a federally sponsored clinical trial is 33.5%.

10. Commonly Requested Start Up Costs • IRB Fee - $2,000 (only if industrially sponsored) • IRB Submission Effort – average is $1,500 - $2,000 • Pharmacy Set Up Fee – determined by Investigational Pharmacy.

11. Commonly Requested Start Up Costs (cont.) • Administrative Start Up Fee – average is $2,000 • Archival/Storage Fee – storage of records after study has been completed. Average budget is $750. • Close out/Queries for Data Lock – Average budget $750 - $1,000.

12. Additional Start Up Fees • Effort for nurse coordinator and PI to attend study start-up meeting hosted by sponsor. • Effort involved for FDA Audit.

13. Non-Refundable Costs • IRB Fee • IRB Submission Effort • Pharmacy Set Up Fee • Administrative Start Up Fee • Even if a study does not enroll any patients you need these basic costs covered.

14. Screen Failures • Goal is to get at least the cost for the first visit covered if a patient does not pass the screening process. • Many Sponsors want to pay a minimal amount for screen failures. • Evaluate your study to determine if you expect to have several patients drop out. • Negotiate with the sponsor on this number.

15. Budget Feasibility • Is it feasible to conduct this trial with the current budget from the Sponsor? • If it is not feasible, then what is the bottom line amount you must have?

16. Negotiating the Budget • Find out who the contact is at the pharmaceutical company that you should work with. • Send an email or call the contact person and introduce yourself. • Send via email your detailed spreadsheet with the proposed IU budget and ask the Sponsor to review it.

17. Internal Budget • IU requires that a brief internal budget be included when you route your contract. • Example: Direct Costs $25,000 Indirect Costs 6,250 (25% IC rate) IRB Fee 2,000 Total Costs $33,250

18. Routing of the Contract • You can route your contract while the budget is being negotiated. • Just note on the route sheet that the budget is not finalized yet. • It is preferred that you use an ERA route sheet and attach the electronic files for the internal budget and contract.

19. QUESTIONS? • Contact Jean Mercer • Phone: 278-5843 • Email: jemercer@iupui.edu