1. Clinical Trials 1 Darlene Kitterman, MBA, Director, Investigator Support & Integration Services (ISIS), Oregon Clinical & Translational Research Institute (OCTRI)

2. Audience This course is intended for “department administrative staff”—including clinical research coordinators, department administrators, division managers, department fiscal managers, department effort coordinators, etc.

3. Introduction This course follows the financial life cycle of a clinical trial up to clinical trial implementation:  Policies and guidance  Budget preparation  Payment schedules  Set-up of Accounts  Third party payer approvals

4. What is a Clinical Trial at OHSU? Clinical Drug/Device Investigation  Mission code 54  A study of a drug (device, or diagnostic) where it “…is administered or dispensed to, or used involving, one or more human subjects.” and is a "prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical...interventions (drugs,... devices, or new ways of using known drugs...or devices).”  Translation: A drug or device intervention into a person

5. Clinical Trial Financial Policies and Guidance Research Study Rate Request, Account(s) Setup And Billing Of Clinical Services (ADM 05.17) Charges For Research Support (ADM 2.17) Use of Devices in Patients and Research Subjects (ADM 05.18) Sponsored Projects Budgets and Cost Coverage (No. 04-40-020) ORIO Enrollment Incentive Policy Research Documentation in the Integrated Health Record (HC-CLN-IHR-P005)

6. Clinical Trial Financial Tools OHSU Hospitals and Clinics Research Rates, Accounts, Registration, Admission, and Charging Processes and Forms Webpage: http://ozone.ohsu.edu/research/rates/index.shtml http://ozone.ohsu.edu/research/rates/index.shtml Clinical Trial Budget Templates  Industry: http://ozone.ohsu.edu/research/rates/budget_template.xls http://ozone.ohsu.edu/research/rates/budget_template.xls  Federal: http://ozone.ohsu.edu/research/rates/federalbudget.xls http://ozone.ohsu.edu/research/rates/federalbudget.xls Clinical Trial Budget Checklist: http://www.ohsu.edu/research/crp/docs/budgetchecklist.doc http://www.ohsu.edu/research/crp/docs/budgetchecklist.doc OHSU Hospital Services Charging Process For Research Studies: http://ozone.ohsu.edu/research/rates/researchaccount.pdf http://ozone.ohsu.edu/research/rates/researchaccount.pdf Clinical Study Billing Table: http://ozone.ohsu.edu/research/hscs/billingtable.doc http://ozone.ohsu.edu/research/hscs/billingtable.doc Medicare Advantage Tools:  http://ozone.ohsu.edu/research/rates/Medicare_Advantage_Patient_Handout.pdf http://ozone.ohsu.edu/research/rates/Medicare_Advantage_Patient_Handout.pdf  http://ozone.ohsu.edu/research/rates/Procedure_to_assign_guarantor.pdf http://ozone.ohsu.edu/research/rates/Procedure_to_assign_guarantor.pdf

7. Budget Preparation Analyze costs  Identify standard of care vs. research procedures  Minimum: all research costs must be covered All tests and procedures Salary support (investigator, study coordinator, other) Professional fees (if not already getting salary support) Other invoicable costs (informed consent translation, IRB initial and continuing review fees*, pharmacy**, shipping, storage, subject reimbursement, supplies, advertising, etc.)  If clinical services, complete Clinical Study Billing Table Submitted with to IRB with application Submitted to PBS with Research Rates Request Form *Required if industry sponsored, **Required if study of drug

8. Budget Preparation Determine rates  Hospital Services Technical Fees –Obtain from Clinical Department Contact or Research Rates Database –Federal: »Must use research rate »Hospital price X Research Rate % = Research price –Industry sponsored: »Budget for full price if possible »Will be charged research price (see below) –Budget for ~10% increase per year –Route Research Rate Request Form to obtain research rate (DHHS negotiated rate) Professional Fees –Obtain from Clinical Department Contact or Research Rates Database –Standard discount ($75/RVU) reflected in database –Invoice from UMG reflects discount

9. Budget Preparation Determine rates (cont.)  University service Service center rate Contact manager of service center  Outside vendor Commercial vendor services: Agreement through Logistics Outside organization involved in study: Subcontract through RGC Apply Correct Indirect Cost Rate (IDC)  Industry: 25% Total Cost 20% institutional F&A 5% Department Assessment –Some departments don’t assess, stays in account –Some departments assess more, must add line item in budget –Some divisions assess in addition to department assessment, must add line item in budget  Non-industry: 33.5% Modified Total Direct Cost, excludes Patient care costs Equipment Tuition, etc.

10. Unallowable Costs Industry  Finders fees  Referral fees  Enrollment incentives Federal  All industry unallowable above  Also unallowable costs per A-21 Administrative Preparatory to research, etc.

11. Industry Sponsored Clinical Trial Payment Schedules Specified in contract text or budget Assure appropriate payment milestone and schedule used (based on work performed)  Visits performed  Visit CRFs collected  Patients enrolled  Patients completed  Study milestones

12. Industry Sponsored Clinical Trial Payment Schedules Should not accept long intervals without payment (not > quarterly) Should not accept withhold of large % at end of study (not >20% of study budget) If milestone tied to monitoring:  Need to specify monitoring frequency  Need to include ability to get paid if monitoring outside of specified frequency Include penalties for late payment (10% for > 60 days)

13. Industry Sponsored Clinical Trial Payment Schedules Negotiate upfront payments  Nonrefundable for study preparation IRB preparation IRB review fee ($2,200, required) Contract preparation Budget preparation Advertising (if applicable) Pharmacy set-up (required if involves a drug)  Refundable: negotiated amount up-front to avoid deficit spending (usually number of patient visits)

14. Industry Sponsored Clinical Trial Payment Schedules Other payments to include  Screen failure payment if expensive screening procedures  Event based costs invoiced to sponsor IRB Project Revisions and Amendments ($825, required) Continuing IRB Review ($1,320, required) Pharmacy maintenance fees (if not in per patient budget) Government audits Record storage SAE report preparation (if many and not included in per subject budget) Subject compensation and/or expenses (if applicable) Advertising costs (if applicable) Translation expense (if applicable)

15. What to do with the Budget Grant  Enter information into applicable format (ex: PHS398, SF424, etc.)  Append to grant or contract per instructions

16. What to do with the Budget Industry Sponsor (cont):  Calculate detailed budget to determine actual costs  Determine budget with sponsor Line item budget options –Complete worksheet provided by sponsor –Create budget and give to sponsor –Sponsor proposes line item budget »If covers cost per actual budget, agree »If doesn’t cover cost per actual budget, negotiate »Make changes to sponsor budget once agreed upon Fixed price budget (per patient or per visit) –If covers cost per detail budget, agree –If doesn’t cover cost per detailed budget, negotiate

17. What to do with the Budget Industry Sponsor (cont.)  Sponsor budget attached to contract Line item budgets usually an appendix, fixed price budgets often in the text of the contract If not in the contract, not obligated to pay Changes must be renegotiated and appended to contract –Increased costs –Number of subjects –Extended term Send final budget to contract analyst

18. Prestudy Support Clinical Trials Office (CTO) Prestudy Unit: If industry sponsored, the CTO can do your budget (and IRB submission, and account requests) for you!  Paid by sponsor  http://www.ohsu.edu/research/crp/cto/index.shtml http://www.ohsu.edu/research/crp/cto/index.shtml Investigator Support & Integration Services (ISIS): Can assist with non- Industry clinical research budgeting and regulatory submissions  First clinical research grant: FREE  Funded investigator: Fee depending on service  http://www.octri.org/octri/public/index.aspx?pageid=76&siteid=1&menuid= 18&siteid=1&siteid=1&MenuSelectedIndex=1 http://www.octri.org/octri/public/index.aspx?pageid=76&siteid=1&menuid= 18&siteid=1&siteid=1&MenuSelectedIndex=1 Contact Bridget Adams, Manager, 4-5077

19. Tracking Your Award Track preaward process through set-up via “The Jellyfish”: http://rishtmldb.ohsu.edu:7042/pls/risprod/f?p=13 2:1:14251149068476920202 http://rishtmldb.ohsu.edu:7042/pls/risprod/f?p=13 2:1:14251149068476920202  Which office is handling your study  Which analyst is responsible  Status

20. OGA Account Set-Up Award Packet transferred to Sponsored Projects Administration (SPA) from preaward office  Industry Sponsored: Contract executed –After all compliance approvals –After receipt of final budget from study team or sponsor Contract copy sent to PI and Study Coordinator  All other: Award notice received from funding agency All DAC items completed

21. OGA Account Set-Up Set-up Process Overview  Award and Project(s) set up in OGA  Notice of Acceptance (NOA) sent to Principal Investigator (PI) and “Award/Project Dept Fiscal Manager” with OGA Project Number and Alias  Timeline 5 business day target – from receipt of account setup packet in SPA to NOA email to PI In future, industry sponsored clinical trials: 24 hours to receipt of abbreviated NOA with OGA alias Information on OGA account set-up:  Account Set-Up Process Flowchart: http://www.ohsu.edu/research/rda/spa/docs/applic1.pdf http://www.ohsu.edu/research/rda/spa/docs/applic1.pdf  More details available in SPA 101 course

22. Industrial Account Setup Required if charging hospital services to a research account Complete Research Rate Request and submit to Patient Business Services (PBS)  Can be completed as soon as study procedures determined  Includes: Research Rate Request Form (p. 1 always required, p.2 required only if study services billed to the subject) Protocol/research plan IRB Lay Language Summary Copy of Clinical Study Billing Schedule from IRB IRQ  Signature from all OHSU departments providing clinical services for study

23. Industrial Account Setup Complete Industrial Account Request Form and submit to PBS  After receive OGA Project Number  Research Rate Request must have been submitted  An industrial account for a different study may NOT be used while waiting for a new account number

24. Medicare Approval for Devices Applies to:  Category A devices for “life-threatening conditions”  Category B devices  Humanitarian Use Devices (HUD/HDE) Must obtain approval from Medicare prior to using device in Medicare patients HDEs also require patient specific approval (will be contacted by Melanie Hawkins, Clinical Research Billing Manager when Medicare approval for the HDE obtained)

25. Medicare Approval for Devices After:  IRB approval  Contract negotiation complete or grant awarded, if applicable Complete OHSU Investigational and Humanitarian Device Medicare Pre-Approval Form Obtain signatures of PI on letter and certification Send to Melanie Hawkins, Clinical Research Billing Manager Wait for Medicare approval

26. Tips to Assure Correct Billing Complete Research Rate Request form early and involve all Hospital Departments providing services Use paper order form (downtime slip) to order services directed to the industrial account If OHSU clinical services performed for research purposes:  Obtain an medical record number (MRN) for all subjects, even if not an OHSU patient  Create research FYI after subject signs informed consent form If study involves standard of care clinical procedures  Participation in clinical trial must be preauthorized with private insurers  If subject enrolled in Medicare Advantage Plan services must be billed to traditional Medicare Potential significant financial impact to subject, must be informed Need to inform registration (email reghelp and Melanie Hawkins) Register/admit subjects appropriately  Inpatient: Use Request for Research Subject Admission Form  Outpatient: If scheduling subjects in Cadence for research related visit: Make sure research visit type utilized if visit for research purposes only (no standard of care), provide scheduler with industrial account number If includes standard of care, should be regular clinical visit