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

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 guidance
Budget preparation
Payment schedules
Set-up of Accounts
Third party payer approvals
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
Clinical Trial Financial
Resources
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OHSU Hospitals and Clinics Research Rates, Accounts,
Registration, Admission, and Charging Processes and Forms
Webpage: http://ozone.ohsu.edu/research/rates/index.shtml
Clinical Research Billing Office:
http://www.ohsu.edu/xd/research/about/integrity/irb/clinicalresearch-billing.cfm
Budget Preparation

Analyze costs
Identify standard of care vs. research procedures
Minimum: all research costs must be covered
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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 rates
 Hospital 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 Schedule
 Obtain Research Rates
 Obtain Research Account
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Clinical Study Billing
Schedule


List all services listed in the protocol
Code each service
INS for insurance
RES for research industrial account
NC for no charge
Submit with to IRB with Initial Review Questionnaire
(IRQ)
 Submit to PBS with Research Rates Request Form
 See 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 study

 Lay language summary
 Full 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
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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.
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
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)
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.)
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Other payments to include
Screen failure payment if expensive screening
procedures
Event based costs invoiced to sponsor
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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

Grant
Enter information into applicable format (ex:
PHS398, SF424, etc.)
Append to grant or contract per instructions
What to do with the Budget
(cont.)
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Industry Sponsor:
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
What to do with the Budget (cont.)
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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 submissions
Industry sponsored: paid by the sponsor (free to
investigator)
First clinical research grant: FREE
Funded investigator: Fee depending on service
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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=13
2:1:14251149068476920202
Which office is handling your study
Which analyst is responsible
Status
OGA Account Set-Up
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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 Department Administration Checklist (DAC) items completed
OGA Account Set-Up
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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

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
Research Account
Setup
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Also called “industrial” account
Required if charging hospital services to an OGA
alias
Complete industrial account request form
 After approval of research rates
 After receive OGA alias
 Send to PBS
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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
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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
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After:
Medicare Approval for
Devices
IRB approval
Contract negotiation complete or grant awarded, if applicable
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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
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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:
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If study involves standard of care clinical procedures
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 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
 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
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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