BUDGETING FOR INDUSTRY SPONSORED CLINICAL TRIALS

1. BUDGETING FOR INDUSTRY SPONSORED CLINICAL TRIALS Weill Medical College of Cornell University Institute for Clinical Research Office of Clinical Trials Administration

2. Industry Sponsored Clinical Trial Budgets Steps: • Pre-budget Preparation • HRBAF Preparation • Initial Budget Drafting • Feasibility Meetings • Further Develop the Study Budget Draft • Final HRBAF Verification • Account Set-up & Initial Invoicing

3. Budgeting Steps for Clinical Trials

4. Step 1

5. Pre-Budget Preparation • Understand the Study • Do a 3 Point Comparison • Compare & contrast to ensure all procedures/events are included in these 3 documents: • Informed Consent Form (ICF) • Schedule of Events (within Protocol) • Sponsor’s Budget Line Items

6. Step 2

7. HRBAF Preparation • List protocol activities on the HRBAF • Human Research Billing Analysis Form • Formerly CTAF or Billing Compliance Form • Determine whether procedures are Standard of Care or Research Specific • Obtain CPT & ICD9 codes • Refer to your Department Billing Compliance Liaison • http://intranet.med.cornell.edu/billingcompliance/pdf/2_2_dep_com_sta.pdf • Refer to instructions for HRBAF • http://intranet.med.cornell.edu/billingcompliance/pdf/InstructionsIV.pdf

8. Step 3

9. Initial Budget Drafting • Tips: • Obtain costs for conducting trial activity • Use codes from HRBAF • ICR Templates available • Consider factors that impact the study budget: • Sponsor Initiated v. Investigator Initiated • Device v. Drug • Phase I, II, III, IV • Ancillary Research Services • Administrative Tasks

10. Building the Budget • Review & Consider • Payment Schedule—based on CRF completion, milestones • Study Duration—include inflation factor • Invoiceable Fees • Ex: Advertising, Patient Travel Reimbursement, Screen Failures, Regulatory Continuing review fees, Postage, Amendments, Monitoring Visits

11. Mandatory Fees • Mandatory Fees • Get estimate from Research Pharmacy • Contact them at 746-0743 • Non-refundable Initial Payment including: • IRB Fee: $1,500 (set by RASP) • Start up costs (determined by department) • IDC: 33%(set by WCMC Board of Trustees)

12. Per Patient Budget • Activity Based Procedures • Calculate time spent on activity based procedures such as: • Consenting subjects • Chart Review • Adverse Event Reporting • CRF Completion • Amendments • ICR has created a Salary Calculation Worksheet to assist with this process

13. Per Patient Budget • Clinical Procedures • Use CPT codes & Negotiated rates for Patient Services to determine service fees for clinical procedures such as: • Office Visitation, CBC, ECG, X-ray • Be sure to include both Professional AND Technical Fees • Technical Fee: any services performed by NYPH • Professional Fee: any services performed by WCMC Physician • Technical fees available on the billing compliance website • http://intranet.med.cornell.edu/billingcompliance/pdf/nyph_research_fees_wmc.xls

14. Step 4

15. Feasibility Meeting Scheduling • Contact your Contracts Specialist • Meeting will include: • Principal Investigator (if possible) • Study Coordinator • Departmental/Divisional Financial Analyst (if different than Study Coordinator) • OCTA Financial Analyst (if available) • Bioethicist (if available) • Contracts Specialist—Facilitator

16. Feasibility Meeting Preparation • Send electronic drafts to the Contract Specialist: [5 days in advance of meeting] • HRBAF—completed in full, does not require signatures • Protocol—as submitted by Sponsor • ICF—draft before sending to IRB for review • Budget—draft of actual costs, PI’s proposal • ICR will provide Feasibility Checklist

17. Step 5

18. Further Develop the Study Budget Draft • Incorporate changes discussed in Feasibility Meeting • Hidden costs • Missing procedures • Negotiate with Sponsor and finalize budget • Contact OCTA should you require any assistance

19. Step 6

20. Final HRBAF Verification • VERIFIED by Billing Compliance Liaison • APPROVED & SIGNED by: • Principal Investigator AND • Department Chair/Division Chief OR • Department/Division Administrator • SEND completed HRBAF to IRB • Copy to OCTA, not mandatory, but helpful.

21. Step 7OCTA’s Responsibility

22. Account Set-up & Initial Invoicing • Once the contract is executed & the IRB approval is obtained: • Initial Invoice is sent by OCTA to Sponsor to collect the IRB & Study Start-up Fees • Note: All further invoices to be sent by PI’s Dept. • OCTA should receive all study payments • OCTA opens an FRS Account • Using FRS #, OCTA obtains study specific Eagle Plan Code from NYPH, if Study has hospital services • Note: FRS Account # = Eagle Plan Code #

23. Helpful Hints for Invoicing • Include some or all of the following on invoice to Sponsor, and ask them to include a copy of invoice or the information with the payment: • Short Title of clinical trial • Date of invoice • Department name • PI Name • Sponsor name • Sponsor contact information • Sponsor study/protocol number • Itemization, rate, and extension for each activity submitted for payment • Total amount due • Contact information for OCTA All Payments to: Weill Medical College of Cornell University Attn: Office of Clinical Trials Administration 1300 York Ave, Box 305 New York, NY 10021

24. 3 PRONG PROCESS