1. Clinical Trials Budgeting, Part 2

2. Agenda Overview of clinical trials fund setup by OSP/OSPA Invoicing for study start-up fees Invoicing for per patient/milestone capitation funds Tracking patient enrollment and/or study milestones Understanding study income versus study costs Closing out study funds

3. OSP Award Process In order to “Award” (process a study for fund set up) a clinical trial, OSP requires: – Fully Executed Contract – “Internal” Budget identifying CMH costs – Review Committee Approvals – Routing Form

4. OSP Award Process Con’t. Once OSP has all those items, OSP will do some data entry, issue the Award to the PI via email, and generate a Fund Set Up Sheet The Fund Set Up Sheet shows OSPA which account categories to open in Lawson so charges can post to the fund, as well as other information such as whether the fund needs to be set up in Epic, invoicing info, etc.

6. Fund Set-Up for Clinical Trials Industry-sponsored clinical trial budgets are generally based on a per patient reimbursement rate. As such, the budget is set up as $0 because the final amount depends upon how many patients are enrolled. The internal budget is important not only to identify costs but to help OSPA set up all the necessary expense categories, so payment delays are avoided. REMEMBER to inform OSP if your study will need to be set up in Epic! OSP in turn will include this information for OSPA on the fund set-up form.

7. Start-Up Invoicing The first costs that might be billed to a clinical trial fund are start up costs. These might include: – IRB Review – Administrative Set Up – Medical Imaging fees – Pharmacy start-up fees OSP will bill the sponsor and the fund for these expenses when the contract is awarded.

9. Invoicing for Visits or Ancillary Fees Refer to CTA (or Fund Set Up Form) to determine if invoices required and/or template provided. Many (but not all) sponsors will pay automatically based upon completion of milestones and CRFs. If invoicing is required, several invoice templates are available (i.e. CMH Standard Invoice on SharePoint). Ask sponsor send a copy of the invoice with the check & include the fund number on the check. OSP can review invoice prior to submission. Send copies of invoices to OSP for better follow-up.

13. Tracking Enrollment/Milestones Important to keep careful track of patients enrolled and study milestones achieved. Use Case Report Forms (CRFs) and Electronic Data Capture (EDC) records. Create a shadow system.

14. Sample Shadow System Visit AmountSubject XYZSubject ABCSubject DEF Subject GHI Screening 1 $ 800.00Rec'd 2/24/10Rec'd 3/30/10 Rec'd 4/28/10 Screening 2 $ 925.00Rec'd 2/24/10Rec'd 3/30/10 Rec'd 4/28/10 Day 1 $ 900.00Rec'd 3/30/10Rec'd 4/28/10 Rec’d 5/31/09 Week 2 $ 600.00Rec'd 4/28/10Rec’d 5/31/10 Week 4 $ 600.00Rec’d 5/31/10 Week 6 $ 600.00 Week 8 $ 600.00 Week 12 $ 600.00 Week 18 $ 600.00 Week 24 $ 600.00 Week 30 $ 600.00 Week 36 $ 75.00 Week 40 $ 600.00 Week 44 $ 75.00 Week 48 $ 600.00 F/U 4 $ 500.00 F/U 12 $ 500.00 F/U 24 $ 500.00

15. Tracking Sponsor Payments All checks should be sent to OSP (as indicated on your invoice). If you happen to receive a check, please forward immediately to Rochanna Thomas, OSP, Box 205 for deposit. Payments are sent to OSPA twice a week for deposit. For PPR Pharma Studies, payment is posted in Lawson under code 90301 For PPR Non-Pharma Studies, payment is posted in Lawson under code 90102

16. Sponsor Income v. Study Costs Even though patient/milestone capitations are built on us estimating our site’s actual costs, and these are regularly paid and deposited, we still need to keep track of all study related expenses and make sure they are billed to the study fund. Lawson LBI and Epic are good tools to help you track! Keep track of all patient care expenses and make sure research study charges are being billed properly through Epic. Keep track of all PI and CRA hours that should be billed to the fund. Salary costs should be billed to clinical trial funds by periodic payroll transfers rather than by setting up an employee template to bill a specific % of time every pay period.

17. Clinical Trial Fund Close Out Close out generally 60 days after end date. All income must be received and all expenses appropriately charged to the fund. If a study fund has an unexpended balance, a fixed price balance transfer form must be completed and submitted to OSP. Form is filled out by the PI and/or a designee. PI must detail why there is a balance if it is greater than $10,000 or 25% of the award. This is done to ensure that proper financial management procedures have been utilized during the project. If minimal, no explanation needed.

18. Clinical Trial Fund Close Out Indirect costs are taken out before the balance is transferred. OSP staff will assist in determining the correct amount to be transferred. Funds are deposited into a research discretionary fund, but must be used for future research related work.

19. Questions? Kristine Martens, JD Assistant Director, Grants & Contracts Office of Sponsored Programs Ann & Robert H. Lurie Children’s Hospital of Chicago 225 E. Chicago Ave., Box 205 Chicago, IL 60611 773.755.6561 KIMartens@luriechildrens.org