Clinical Trials 1

Darlene Kitterman, MBA, Director,

Investigator Support & Integration Services (ISIS), Oregon Clinical & Translational Research Institute (OCTRI)

Audience

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

Introduction

This course follows the financial life cycle of a clinical trial up to clinical trial implementation:Policies and guidanceBudget preparationPayment schedulesSet-up of AccountsThird party payer approvals

What is a Clinical Trial at OHSU?

Clinical Drug/Device InvestigationMission code 54A 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

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)

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

Budget Preparation Analyze costs

Identify standard of care vs. research proceduresMinimum: 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

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

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.

Unallowable Costs

IndustryFinders feesReferral feesEnrollment incentives

FederalAll industry unallowable aboveAlso unallowable costs per A-21

• Administrative• Preparatory to research , etc.

Industry Sponsored Clinical Trial Payment Schedules

Specified in contract text or budgetAssure appropriate payment milestone and

schedule used (based on work performed)Visits performedVisit CRFs collectedPatients enrolledPatients completedStudy milestones

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 frequencyNeed to include ability to get paid if monitoring outside of

specified frequency Include penalties for late payment (10% for > 60 days)

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)

Industry Sponsored Clinical Trial Payment Schedules

Other payments to includeScreen failure payment if expensive screening proceduresEvent 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)

What to do with the Budget

GrantEnter information into applicable format (ex:

PHS398, SF424, etc.)Append to grant or contract per instructions

What to do with the Budget

Industry Sponsor (cont):Calculate detailed budget to determine actual costsDetermine 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

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

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

Tracking Your Award

Track preaward process through set-up via “The Jellyfish”: http://rishtmldb.ohsu.edu:7042/pls/risprod/f?p=132:1:14251149068476920202Which office is handling your studyWhich analyst is responsibleStatus

OGA Account Set-Up

Award Packet transferred to Sponsored Projects Administration (SPA) from preaward officeIndustry Sponsored:

• Contract executed– After all compliance approvals– After receipt of final budget from study team or sponsor

• Contract copy sent to PI and Study CoordinatorAll other:

• Award notice received from funding agency• All DAC items completed

OGA Account Set-Up Set-up Process Overview

Award and Project(s) set up in OGANotice 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

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

Industrial Account Setup

Complete Industrial Account Request Form and submit to PBSAfter receive OGA Project NumberResearch Rate Request must have been submittedAn industrial account for a different study may NOT

be used while waiting for a new account number

Medicare Approval for Devices

Applies to:Category A devices for “life-threatening conditions”Category B devicesHumanitarian 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)

Medicare Approval for Devices

After:IRB approvalContract 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

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