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 staffincluding 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.ed
  u/research/rates/index.shtml
• Clinical Trial Budget Templates
• Industry http//ozone.ohsu.edu/research/rates/bu
  dget_template.xls
• Federal http//ozone.ohsu.edu/research/rates/fed
  eralbudget.xls
• Clinical Trial Budget Checklist
  http//www.ohsu.edu/research/crp/docs/budgetcheckl
  ist.doc
• OHSU Hospital Services Charging Process For
  Research Studies http//ozone.ohsu.edu/research/
  rates/researchaccount.pdf
• Clinical Study Billing Table http//ozone.ohsu.ed
  u/research/hscs/billingtable.doc
• Medicare Advantage Tools
• http//ozone.ohsu.edu/research/rates/Medicare_Adva
  ntage_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 FA
• 5 Department Assessment
• Some departments dont 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 gt quarterly)
• Should not accept withhold of large at end of
  study (not gt20 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 gt 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 doesnt 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 doesnt 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?pagei
  d76siteid1menuid18siteid1siteid1MenuSele
  ctedIndex1
• Contact Bridget Adams, Manager, 4-5077

19
Tracking Your Award

• Track preaward process through set-up via The
  Jellyfish http//rishtmldb.ohsu.edu7042/pls/ri
  sprod/f?p132114251149068476920202
• 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