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 Financial Resources

OHSU Hospitals and Clinics Research Rates, Accounts, Registration, Admission, and Charging Processes and FormsWebpage: http://ozone.ohsu.edu/research/rates/index.shtml

Clinical Research Billing Office: http://www.ohsu.edu/xd/research/about/integrity/irb/clinical-research-billing.cfm

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, document storage, subject reimbursement, supplies, advertising, etc.)

*Required if industry sponsored, **Required if study of drug

Budget Preparation

Determine ratesHospital Services

• Obtain rates from Clinical Department Contact or Research Rates Database

• Technical Fees– 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• 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 (TC)

• 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: 32% Modified Total Direct Cost (MTDC), excludes• Patient care costs• Equipment• Tuition, etc.

Clinical Services

Complete Clinical Study Billing ScheduleObtain Research RatesObtain Research Account

Clinical Study Billing Schedule

List all services listed in the protocolCode each service

INS for insuranceRES for research industrial accountNC for no charge

Submit with to IRB with Initial Review Questionnaire (IRQ)

Submit to PBS with Research Rates Request FormSee CRBO website for additional information

Can be completed as soon as study procedures determined

Includes:• Research Rate Request Form• Protocol/research plan• IRB Lay Language Summary• Copy of Clinical Study Billing Schedule from IRB IRQ

Research Rates

Complete Research Rate Request Form as soon as know study procedures

Obtain signature from all OHSU departments providing research related clinical services for studyLay language summaryFull study protocol

Forward all signed forms to Patient Business Services (PBS) with a copy of the Clinical Research Billing Schedule

Only charges to departments with a signed form for the study will receive the research rate, corrections will not be made retroactively

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 (cont.)

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 (cont.)

Industry Sponsor: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 (cont.)

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

Investigator Support & Integration Services (ISIS): Can assist with clinical research budgeting and regulatory submissionsIndustry sponsored: paid by the sponsor (free to

investigator)First clinical research grant: FREEFunded investigator: Fee depending on service

Contact Bridget Adams, Manager, 4-5077 or www.octri.org

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 Department Administration Checklist (DAC) items completed

OGA Account Set-Up

Set-up Process OverviewAward 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

Information on OGA account set-up:Account Set-Up Process Flowchart:

http://www.ohsu.edu/research/rda/spa/docs/applic1.pdfMore details available in SPA 101 course

Research Account Setup

Also called “industrial” accountRequired if charging hospital services to an OGA aliasComplete industrial account request form

After approval of research ratesAfter receive OGA aliasSend to PBS

Use research account on orders to direct services to OGA instead of subject’s insurance

An 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

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 CRBO CRBO will submit to Fiscal Intermediary 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 clinical services directed to the

research 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 Have consent form scanned into Epic

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• 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 research account number

• If includes standard of care, should be regular clinical visit