The Business Operations of Clinical Research Trials, From Start to Finish

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The Business Operations of Clinical Research
Trials, From Start to Finish
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The Preaward Process
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Confidentiality Agreements

• One Way
• A company may want to send a protocol to the
  Principle Investigator (PI) so that he/she can
  decide whether to participate in the trial
• The protocol will have confidential information
  that the company needs to safeguard
• The sponsor may wish to support a Principal
  Investigator by supporting travel to a conference
  which may have confidential information
• Two Way (Mutual) or One Way Out
• A Principal Investigator may want to request a
  sponsor to support their own research

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How does this work?

• Principal Investigator contacts University
  administration looking for assistance
• Sponsor contacts PI/Coordinator
• Sponsor contacts University administration
• In order to protect the University and the PI,
  all CDAs require University signature
• Each must be reviewed, negotiated and executed by
  the PI, University Official and the Company.

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Negotiation

• CDAs are usually straightforward and require
  little negotiation
• Point of contact Roseann Talarico 3-4743
• roseann.talarico_at_je
  fferson.edu
• Most are negotiated within 5-10 business days
• Include the name, address, telephone number and
  the Sponsor/CRO email/phone
• If needed, include a note with any concerns about
  the CDA or what confidential information
  University may wish to protect
• Once completed PI will receive executable copy
  return to complete the execution process
• Fully executed copy sent to PI for recordkeeping

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What is required to begin the business process?

• Key indicators
• Fully executed CDA
• Cancer Center
• MDG/PRC approvals
• Department staff/coordinator provides documents
  to business office
• Electronic Proposal Transmittal Form (ePTF) is
  created
• What is the (ePTF) and what is it for?
• Electronic mechanism for Jefferson to manage,
  maintain, and approve all research
• Grants
• Contracts

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What forms are required?

• Materials required to complete (ePTF) for the
  first round approval
• Protocol
• Draft Informed Consent (ICF)
• Clinical Trial Agreement (CTA)
• Sponsor Budget

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What is the approval process?

• First round approval
• Department administrator/PI/Chair approve
• MCA/contract/budget negotiation process begins
• Second round approval
• MCA/contract/budget negotiated
• IRB approved
• Department administrator/PI approve
• Execution of contract/account set up

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JCRI Business OperationsCoverage Analysis
Budget
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Coverage Analysis
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Materials needed to conduct a Coverage Analysis

• From Study Team
• Same as (ePTF) process
• Protocol
• Draft Informed Consent (ICF)
• Clinical Trial Agreement (CTA)
• Sponsor Budget
• Approved electronic proposal transmittal form
  (ePTF)
• First round only

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What is a Coverage Analysis?

• Document that determines the appropriate payor
  (i.e. Sponsor, Medicare or third party payor) for
  each item and service required by a clinical
  research trial

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Why is a Coverage Analysis important?

• Reduces risk for submitting false claims
• Billing for services not part of a qualifying
  clinical trial
• Billing for items and services promised/paid for
  by Sponsor
• Billing for research only items and services
• Assists in budget negotiations with Sponsor/CRO
• Identifies costs that need to be accounted for in
  the sponsor budget
• Basis of billing compliance/audits
• Provides evidence of due diligence and a
  mechanism for compliance with billing rules

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Coverage Analysis Process

• Receive all materials from the study team
• Create a grid that reflects all clinical events
  and time points in the protocol
• Review clinical guidelines along with CMS
  national and local coverage determinations to
  identify the appropriate payor for each event
• Send the CA to PI/SC for review and approval
• Approve or revise the CA as necessary

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Clinical Trial Budget
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Develop a financial plan that encompasses all
phases of the study

• Start-up costs
• Institutional costs
• Other costs incurred throughout the study
• Subject costs

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Develop a financial plan that encompasses all
phases of the study

• Start-up costs
• training, meetings, IRB/regulatory work, source
  document creation
• Institutional costs
• Other costs incurred throughout the study
• Subject costs

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Start-Up Costs
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Develop a financial plan that encompasses all
phases of the study

• Start-up costs
• training, meetings, IRB/regulatory work, source
  document creation
• Institutional costs
• FA, IRB fees, billing compliance fees
• Other costs incurred throughout the study
• Subject costs

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Develop a financial plan that encompasses all
phases of the study

• Start-up costs
• training, meetings, IRB/regulatory work, source
  document creation
• Institutional costs
• FA, IRB fees, billing compliance fee
• WIRB/Quorum One time fee 2,500
• Other costs incurred throughout the study
• site monitor fees, IRB work on continuing reviews
  or amendments, dry ice, close-out costs, etc.
• Subject costs

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Other Costs
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Develop a financial plan that encompasses all
phases of the study

• Start-up costs
• training, meetings, IRB/regulatory work, source
  document creation
• Institutional costs
• FA, IRB fees, billing compliance fee
• WIRB/Quorum One time fee 2,500
• Other costs incurred throughout the study
• site monitor fees, IRB work on continuing reviews
  or amendments, dry ice, close-out costs, etc.
• Subject costs
• Any items that are not billable to insurance or
  provided by the sponsor

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Accomplished by considering all stakeholders
input

• PI and Study Coordinator
• Radiology
• Pathology
• Pharmacy
• Hospital Billing
• Professional Services Billing
• Other departments
• Sponsor

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Clinical Trial Agreement
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What is required to complete a contract?

• Who wrote the protocol?
• Sponsor
• Clinical Trial Agreement
• PI/Jefferson
• Investigator Initiated Agreement
• Is the sponsor contract new or previously
  negotiated?
• If new review/red line changes
• Forward to legal
• If previously negotiated similar protocol
• Review/red line changes
• Forward to sponsor

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What is required to complete a contract?

• Negotiate terms
• Ensure budget, billing and payment terms are
  acceptable
• Is the IRB approved?
• Approval letter and informed consent reviewed
• Sponsor and protocol must match contract
• Subject injury and indemnification language
• Different terms in each but intent must be the
  same
• (ePTF) secondary approvals

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What is required to complete a contract?

• Execute
• Forward to PI
• Return to sponsor
• PDF or mail
• Account set up
• Establishment letter to staff and accounting
• MCA includes account number sent to staff and
  billing

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Post Account Establishment

• Modifications/Amendments
• No cost extension
• Change in PI
• Modification to protocol
• No budget modification
• Modification to protocol
• Budget modification
• 5,000 or greater
• (ePTF) supplement
• Approvals, etc.
• Follow same SOPs as a new clinical trial

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• PI I developed and created my own protocol and
  I want to send it to Sponsor for review to
  determine whether they would consider funding
  this very important project for my study. Should
  I just send it to their scientist for review as
  is?

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• PI I just received an email from sponsor
  requesting that I sign the attached CDA so that
  they may immediately send the protocol and
  regulatory documents for review. This will allow
  me the opportunity to begin the process on this
  very lucrative study. May I just sign it and
  return this as is? I dont have time to waste.

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• PI I just signed the required and negotiated
  CDA by sponsor and the university. They
  subsequently sent me the protocol, budget, and
  sample informed consent. I just checked my stock
  portfolio and realize that my wife and I each
  have a few shares of sponsor stock equating to
  approximately 6,000 each. When I approve the
  e-PTF is it necessary for me to mark that I have
  a conflict since I only have around 6,000 of
  stock as its below the threshold? Am I correct?

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• PI I just signed the required CDA by sponsor
  and they subsequently sent me the protocol,
  budget, and sample informed consent. I happen to
  be on the scientific advisory board of this
  sponsor. When I approve the ePTF is it necessary
  for me to mark that I have a conflict since I
  only volunteer on this board. Am I correct?

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• PI The budget and contract are negotiated and
  ready to sign. IRB is still pending. Is it
  acceptable to fully execute the contract prior to
  IRB approval?

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• PI The Office of Research Administration
  requires what 4 (four) items to be submitted to
  your Clinical Research Administrator
  representative in order to begin contract and
  budget negotiation process?

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• PI I just signed the CDA with sponsor and they
  just sent me their protocol, budget, and consent
  document. This study is so right for me and I
  can accrue quite a number of subjects. The
  administrative process at TJU takes so long. How
  can I minimize the timelines so that I can start
  accruing subjects as quickly as possible?

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How to initiate the process

• Please, please, and please one more time reach
  out to your clinical research administrator for
  more information.
• Contact information provided at the end of the
  post award session

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JCRI Business Operations Post-Award
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Invoicing/Milestones/Patient Tracking

• Processes relating to the collection of sponsored
  clinical trial funding

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Invoicing

• Clinical Research Administrator submits invoices
  to the sponsor
• Initial invoice includes startup fees, initial
  IRB fees, billing and compliance and any other
  items listed in the clinical trial agreement
• Ongoing invoices include IRB fees IRB prep
  fees, pharmacy monthly maintenance, site monitor
  fees, advertising, protocol specific procedures,
  other items listed in clinical trial agreement

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Milestone Payments

• Based on finalized contract, milestone payments
  would apply if TJU is paid upon enrollment of a
  certain number of patients, completion and
  collection of case report forms, etc.

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Patient Tracking

• Study calendar set up based on finalized budget
• Calculates amounts due based on the patient
  activity within the study
• May include conditional procedures or services,
  based on the study

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Additional Forms
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IRB Activity
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Invoices Submitted
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Financial Summary of Accounts Receivable
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Clinical Research Coordinator Role

• Communication with your JCRI Clinical Research
  Administrator is key
• Email copies of IRB approval letters,
  documentation for advertising and any other
  supporting documents for invoicing
• Ensure patient trackers are updated timely
• Ask questions to your Clinical Research
  Administrator

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Processing Sponsor Payments
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• Clinical Research Administrator should receive
  all clinical trial payments from the sponsor
• Patient payments paid via CRF
• Payment entered as received on patient payment
  sheet
• Payments reconciled against visits on patient
  visit sheet. BOPS ensures payments received match
  the amounts expected from the sponsor.

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Clinical Research Coordinators Role

• Any payments received related to a clinical trial
  by the research staff should be forwarded to your
  Clinical Research Administrator for deposit and
  proper accounting
• Be prepared to answer questions from the Clinical
  Research Administrator about patient activity

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Clinical Trial Billing

• Ensures that studies are billed for research
  specific procedures

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Clinical Trial Billing

• Entities
• Jefferson University Physicians (JUP)
• Bills related to clinical services sent monthly
  from JUP Business Services
• Hospital
• Bills related to clinical services sent regularly
  from Hospital Business Services

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Jefferson University Physician (JUP) Bills

• Physician professional fees
• Examples Physical exam, evaluation of MRI, ECG
  interpretation, etc.
• Services get billed to grant or patients
  insurance for JUP services. Review billing and
  compliance grid as reference
• Contact for JUP Billing
• Merle Charlton, 3-3311

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Hospital Bills

• Technical Fees for clinical trial services
• i.e. MRI cost, CT scan cost, some clinical labs,
  ECG cost, etc.
• Billed to grant or patient insurance as
  designated by billing and compliance grid
• Contact for hospital billing
• Ed Dunigan, 5-2521

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Clinical Research Coordinators Role

• Keep the billing and compliance grid available
• Be prepared to answer questions your Clinical
  Research Administrator may have

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Payments to Subjects/Vendors
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• Request for Payment form (RFP)
• Petty cash
• Check payments
• Payments to vendors
• http//www.jefferson.edu/content/dam/tju/finance/f
  orm_center/Request_for_Payment_TJU.pdf

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Payments to Patients

• For payments made to patients, as compensation
  for study related activities in the form of petty
  cash an RFP will be submitted to your Clinical
  Research Administrator
• For check payments, the Request for Payment will
  be submitted to your Clinical Research
  Administrator for approval

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Payment to Vendors

• Use Request for Payment form, enter vendor
  information in the address section, attach any
  invoices and be sure to check box for this to be
  included with the check.
• Forward the RFP to your Clinical Research
  Administrator for approval

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Clinical Research Coordinators Role

• Ensure youve included all information on the
  Request for Payment and attached any required
  documentation
• Be prepared to answer questions or provide
  information to your Clinical Research
  Administrator

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Contact Information

• Ronald Polizzi, Director, Business Operations
  JCRI, 3-2127
• Michael Caggiano, Team Lead, 3-4746
• Jennifer Lott, Team Lead, 5-2546
• Jason Salvatore, Senior Research Administrator
  Contracts, 3-2011
• Ann Hastings, Research Administrator Contracts,
  3-5645
• Jenny Campbell, Clinical Research Administrator,
  3-4282
• LouEllen Daniel, Clinical Research Administrator,
  3-5390
• Ryan Massimilla, Clinical Research Administrator,
  3-2890
• Mary Rose Taft, Clinical Research Administrator,
  3-4265