IRB Monthly Meeting

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COMPLIANCEforClinical Trials
CTO

• IRB Monthly Meeting
• February 26, 2008

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(No Transcript)
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Compliance

• The action of conforming to a specification or
  standard and the relevant laws and regulations
  that have been clearly defined.
• Infraction of these laws can have criminal
  and/or civil penalties / consequences

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Compliance over-site at CUMC

• IRB
• Human Subject Research
• Protocol Approval, Modification. Renewal
• Adverse Events Reporting
• Other Reporting Requirements
• Close Out

• Clinical Trials Office
• Administrative execution / Financial management
• Project Submission Industry / NIH
• Contract and Budget Negotiation
• Research Pharmacy
• Hispanic Translation
• Creation of Grant Account / Payment
  Reconciliation / Routine Audits/ Close Out

• Research Administration
• Pre and Post Award Approval requirements
• Preliminary Proposals
• Letters of Intent

• Office for Billing Compliance
• Establish billing procedures
• Govern medical billing practices
• Audit

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Regulatory Compliance

• Refers to the steps that lead to compliance with
  the relevant Laws and Regulations of
• Food and Drug Administration (FDA)
• Office of Inspector General (OIG)
• Centers for Medicare and Medicaid (CMS)
• Office for Human Research Protections (OHRP)
• Department of Health and Human Services (DHHS)

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Pre-award Compliance

• CUMC systems in place ensure, personnel are
  aware of and take steps to comply with, relevant
  laws, regulations and internal policies
• IRB Submission
• Submit protocol via RASCAL
• Include relevant documentation
• Sponsor Protocol
• Investigator Brochure
• Provide supporting information
• IND/IDE documentation
• FDA approval letter
• Complete protocol specific Conflict of Interest
  form
• Answer all questions
• Sign form
• http//www.cumc.columbia.edu/dept/irb/

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Pre-award Compliance

• Informed Consent
• Monetary Incentive to Patients - can represent
  an inducement to consent to participate in a
  clinical trial
• Issues
• determining how much
• timing of payment
• government auditors

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Pre-award Compliance

• Informed Consent
• HIPAA regulations apply to research
• all clinical research involves the collection and
  use of Protected Health Information (PHI)
• the Privacy Rule protects PHI
• research subjects give authorization permitting
  use and disclosure (e.g., to the Sponsor) of
  their PHI
• authorization is obtained from the patient during
  the Informed Consent process
• http//www.columbiaclinicaltrials.org/media/RASCAL
  _HIPAA_Manual.pdf

• Informed Consent
• HIPAA regulations apply to research
• all clinical research involves the collection and
  use of Protected Health Information (PHI)
• the Privacy Rule protects PHI
• research subjects give authorization permitting
  use and disclosure (e.g., to the Sponsor) of
  their PHI
• authorization is obtained from the patient during
  the Informed Consent process
• http//www.columbiaclinicaltrials.org/media/RASCAL
  _HIPAA_Manual.pdf

• Informed Consent
• HIPAA regulations apply to research
• all clinical research involves the collection and
  use of Protected Health Information (PHI)
• the Privacy Rule protects PHI
• research subjects give authorization permitting
  use and disclosure (e.g., to the Sponsor) of
  their PHI
• authorization is obtained from the patient during
  the Informed Consent process
• http//www.columbiaclinicaltrials.org/media/RASCAL
  _HIPAA_Manual.pdf

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Pre-award Compliance

• Conflict of Interest
• Financial Interests
• Office for Human Research Protections (OHRP)
  provides recommended guidance
• CUMC IRB policy

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Pre-award Compliance

• CTO Submission
• Compliance statement
• Tax Exempt Certification
• Research Pharmacy Cost Estimate
• Budget Worksheet
• Hispanic Translation request
• Questionnaire
• Copies of correspondence with Sponsor
• Clinical Trial Agreement
• Sponsor Budget
• RASCAL Proposal Tracking
• http//www.columbiaclinicaltrials.org/index.html

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Pre-award Compliance

• CTO Budget Review
• Each budget is analyzed to establish which items
  and services are billable to insurance
• Medicare Coverage analysis includes a
  Determination of Qualifying Trial and
  Identification of Standard of Care
• All associated research costs are assessed and
  negotiated
• Study Budget and Informed Consent are consistent
• Special needs of Device Trials
• Medicare Letter
• NYP Procurement
• NYP Charge code
• CPT code and Standard of Care assessment

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Pre-award Compliance

• CTO Negotiation of Clinical Trial Agreements
• All clinical trial agreements are negotiated
• A clinical trial can not be initiated until
  contract has been signed
• Contracts are not signed until IRB approval is in
  place
• PI Initiated - studies that have support from the
  sponsor in the form of Drug/Device and/or
  financial support should have a contract and
  budget that protects the PI from
• doing the research in deficit
• indemnity and other contractual risks
• from fraudulent billing issues
• publication rights

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Clinical Trial Registration with
clinicaltrials.gov

• Clinical trial registration is required for
• Investigational New Drug (IND) efficacy trials
  for serious diseases or conditions is required by
  law
• Journal publication of research results
• Principal Investigator holding the IND is the
  responsible party for registering the trial
• NIH grant applications and progress reports
  require that applicable trials must be registered
  and certified
• Exempted from registration are
• Phase 1 investigations
• Compassionate use, Expanded access and Material
  transfer agreements

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Clinical Trial Registration with
clinicaltrials.gov

• Centers for Medicare and Medicaid (CMS)
• Voluntarily include the clinicaltrials.gov
  identifier on all hospital and professional fee
  claims submitted as of April 1, 2008.  
• All trials must be registered prior to enrolling
  patients
• CTO approval process
• Penalties for failure to register
• Designated administrator for CUMC Dr. John
  Ennever
• clinicaltrials.gov home page http//clinicaltrial
  s.gov/
• Protocol Registration System and US Public Law
  110-85 http//prsinfo.clinicaltrials.gov/fdaaa.htm
  l

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Compliance continues
Post-Award

• The study account
• Created by the CTO
• Requires signed contract and IRB approval
• Investigational Device trials special needs
• Informed Consent Process
• No investigator may involve a human being as a
  subject in research covered by this policy unless
  the investigator has obtained the legally
  effective informed consent of the subject or the
  subject's legally authorized representative

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Post-Award

• Patient Enrollment
• Assure enrollment quotas are met as per
  contractual agreement with sponsor
• Patient registration obtain Research Serial
  Number (Red Card)
• Identifies NYP out patient clinical research
  services - such as Radiology or Labs that should
  be charged to the grant (and not the patients
  insurance)
• Routine auditing cycles monitor the billing
  process
• CUMC Office for Billing compliance audits billing
  for research services
• Financial
• Maintain audit log of all new accounts
• Record amendments and extensions in FFE
• Invoice sponsors for one time fees
• Assist PI with billing and collection of payments
  from sponsors
• Reconcile payment activity
• Reconcile financial reports to General Ledger and
  DARTS

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Post-Award

• Maintain IRB Approval
• Submit continuing review application in RASCAL
• Attach latest versions of all relevant material
• funding proposal (grant or contract), sponsor
  protocol, investigator brochure (if the study
  involves an investigational drug), study
  instruments i.e., questionnaire(s) or
  survey(s), IND/IDE documentation, non-CU site
  approvals (e.g., permission to conduct the
  study), and consent forms
• Research continues uninterrupted if renewal
  request is approved before expiration date
• Regulatory Compliance
• Document management - 1572
• Data Safety and Monitoring Reports
• Maintenance of study records
• Reporting of Adverse Events Unanticipated
  Problems involving Risks

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Post-Award

• Patient Compliance
• Drug adherence
• Completion of Diaries Paper vs Electronic
• Data Variance
• Patient Education critical
• Good Clinical Practice - What is Good Clinical
  Practice (GCP)?
• It is a set of internationally recognized
  ethical and scientific quality requirements which
  must be observed for designing, conducting,
  recording and reporting clinical trials that
  involve the participation of human subjects.
• All research personnel must complete the GCP
  training module in RASCAL
• Research with children requires additional
  training Research with Minors module

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Billing Compliance in Clinical Trials

• Research billing is subject to the same federal
  regulations that apply
• to patient claims submitted from private practice
  and falls under the
• compliance policies of both the University and
  the Hospital
• Research related billing must be coded and
  charged based on actual services rendered
• Services must be allowable by regulations
  governing medical billing practices
• Medicare Rules for Clinical Trials
• Use of V70.7 diagnosis code
• Changes in use of QA/QV modifiers
• Including ClinicalTrials.gov identifier on claim
  forms (voluntary)
• Services must be consistent with the informed
  consent signed by the research subject.
• http//www.cumc.columbia.edu/dept/compliance/resea
  rch.html  

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Clinical Trial Billing Goals

• Assess protocol services to determine coverage
  (Medicare)
• Sponsor payment covers cost of all uncovered
  services
• Informed consent notifies participants of costs
• Insurance
• Sponsor
• Identify participants in billing systems
• IDX
• Eagle
• Perform audits
• Ensure compliance
• Obtain sponsor payment summaries
• Reconcile receivables
• Invoice sponsor for any outstanding charges

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How to ensure Compliance

• During the course of the clinical trial it is
  necessary to
• Track
• Audit
• Report
• On activities such as
• patient consent
• adverse events / serious adverse events
• protocol modifications or deviations
• billing compliance

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Who is responsible for compliance

• Principal Investigator
• Members of Research Team
• IRB
• Research Administration
• Clinical Trials Office
• Departmental Administrators
• Department Billing Staff
• Office for Billing Compliance
• Internal Audit

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Questions?

• Debra Fitzpatrick, Manager Risk/ Research
  Compliance
• 212.342.1581
• df2111_at_columbia.edu

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