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