Costing and Contracting in Clinical Research

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Costing and Contracting in Clinical Research

• Rokas Oginskis

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Overview

• Types of Studies
• Types of Funding
• Pre-Award Process Overview
• Post-Award Administration
• Budget Development
• Tools of the Trade
• Study Initiation and Post-Award
• Resources

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Types of Studies

• Cooperative Group or Consortium
• Investigator-Initiated
• Industry Sponsored

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Cooperative Group or Consortium

• An organized group of research sites or
  institutions through which studies are developed,
  approved, and made available to member
  institutions.
• There is usually some sort of master contract or
  agreement outlining the terms of membership,
  responsibilities, payment, etc.
• Individual studies do not usually require their
  own separate contracts or agreements.

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Investigator-Initiated Studies

• Written by our own UC Irvine faculty.
• May receive a variety of sources, or a
  combination of multiple sources of support.
• In contracting, the issues of indemnification and
  intellectual property are areas to examine
  carefully.
• Principal Investigator effort may be handled
  differently for these studies.

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Industry Sponsored Studies

• An industry sponsor will develop a trial or
  study, then seek accrual sites for participation
  in the study.
• The sponsor will then pay UC Irvine to accrue
  patients and collect data for them (fee for
  service).
• Generally, these are the most comprehensive in
  paperwork and requirements.

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Types of Funding

• Grants (federal, state, foundation,
  institutional)
• Gifts
• Contracts
• Departmental funds

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Pre-Award Process Overview

• Preliminary discussion between PI and sponsor
  results in the desire to do the study.
• Confidential Disclosure Agreement (CDA) and
  preliminary qualification steps.
• Protocol, template consent, template clinical
  trial agreement (CTA or contract), template
  budget sent by sponsor.
• Preparation for contracting and regulatory setup
  begins.

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Pre-Award Process Overview

• Budget and Contracting

• Regulatory

• Draft budget prepared, approved, then negotiated
  .
• Clinical Research Finance
• Home Department
• Clinical Departments
• Submit to Sponsored Projects Administration for
  contract negotiation and signoff.

• Regulatory packet
• Prepare study documents
• Submit for committee approvals as required (DSRC,
  GCRC, CTPRMC, RRC, DSMB, Biosafety, Radiation
  Safety)
• Submit for IRB review/approval.

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Post-Award Administration

• Account/Fund Setup (Contracts and Grants
  Accounting) e-synopsis arrives
• Initiation meeting
• Invoicing for Up Front Costs
• Invoicing, financial management of the award,
  contract/budget amendments.
• Closeout

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Budget Development

• Cost categories to consider
• Personnel (salary and benefits)
• Patient care or hospital costs
• Biospecimen or image handling and shipping
• Storage of records or specimens
• Consent translations
• Pharmacy costs
• Specialized training
• FA (26 for clinical trials)

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More AboutPersonnel

• Salary benefits
• Principal Investigator contributing time for
  an industry sponsored study is a no-no.
  (Regulation No. 4)
• Co-Investigatorsabove and beyond normal clinical
  management duties.
• Administrative personnel and study
  coordinatordont forget work done up front.
• Research vs. clinical nurseswhos doing what?

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More AboutPatient Care or Hospital Costs

• Clinical Research Finance Assessment and the
  Budget Maker online system provide and approve
  research rates for hospital costs.
  https//intranet.ha.uci.edu/crfa/research01.htm
• These rates are to be used for those costs paid
  for by the sponsor.
• Each step or procedure in the study should be
  designated up front as routine care or research
  paid in order for billing to be handled
  appropriately.

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Budget Development

• Format
• Grant budget structure vs. contract structure
• Sponsor templates vs. internal templates
• Up front, per patient, invoice-based, time
  dependent
• Payment terms and schedule

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Grant Budget Structure
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Contract Budget Structure

• Payment section of the contract language
• 5 or 10 hold until.
• Up front vs. per patient
• Invoicing
• Timing of payment vs. work performed
• Payment trigger and frequency
• FA

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Tools of the TradeBudget Worksheet
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Tools of the TradeEstimated Time Worksheet
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Tools of the Trade Internal Study Budget
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Wrapping It Up

• Negotiate the budget with the sponsor.
• Submit documents to SPA for language negotiation
  and signoff.
• Administrative Approval Form (AA form) with
  internal approvals
• 700-U Disclosure of Financial Interest
• PI Questionnaire (for clinical trials)
• Protocol
• Internal budget (negotiated)
• Template Clinical Trial Agreement (CTA) you may
  pre-review and highlight any red flags for your
  officer.
• SIGNATURES!!!

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Study Initiation and Post-Award

• Account/Fund setup and invoicing for up fronts
• Initiation Meeting
• Study conduct and financial management
• Closeout

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Resources

• Office of Research Administration
• www.rgs.uci.edu/ora
• Sponsored Projects Administration
• Institutional Review Board
• Clinical Research Finance/Budget Maker
• https//intranet.ha.uci.edu/crfa/research01.htm
• Paula Hilbert, CRF Office [phone]