Clinical Trials Budgeting, Part 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

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

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.

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.

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.

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.

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.

Sample Shadow SystemVisit Amount Subject XYZ Subject ABC Subject DEF Subject GHI

Screening 1 $ 800.00 Rec'd 2/24/10 Rec'd 3/30/10 Rec'd 3/30/10 Rec'd 4/28/10

Screening 2 $ 925.00 Rec'd 2/24/10 Rec'd 3/30/10 Rec'd 3/30/10 Rec'd 4/28/10

Day 1 $ 900.00 Rec'd 3/30/10 Rec'd 4/28/10 Rec'd 4/28/10 Rec’d 5/31/09

Week 2 $ 600.00 Rec'd 4/28/10 Rec’d 5/31/10 Rec’d 5/31/10

Week 4 $ 600.00 Rec’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

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

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.

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.

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.

Questions?

Kristine Martens, JDAssistant Director, Grants & ContractsOffice of Sponsored ProgramsAnn & Robert H. Lurie Children’s Hospital of Chicago225 E. Chicago Ave., Box 205Chicago, IL 60611773.755.6561KIMartens@luriechildrens.org