Clinical Trials 1

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 FinancialPolicies 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 FormsWebpage: http://ozone.ohsu.edu/research/rates/index.shtml • Clinical Trial Budget Templates • Industry: http://ozone.ohsu.edu/research/rates/budget_template.xls • Federal: http://ozone.ohsu.edu/research/rates/federalbudget.xls • Clinical Trial Budget Checklist: 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 • Clinical Study Billing Table: 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/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 • 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 • 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=132:1:14251149068476920202 • 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 • 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