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Key Compliance Issues In Clinical Research: What Sites, CROs, and Start-Ups Need to Know

Clinical research presents a host of potential compliance and legal risks. This webinar will provide an overview of key legal issues in clinical research applicable to all involved parties, including sponsors, sites and CROs. We will also review recent enforcement activities related to research studies, and provide strategies for addressing issues that arise, both preemptively (through compliance plans) and in response to identified concerns.

Our agenda:
• Understand key rules and regulations and how they apply in the context of clinical research
• Review key areas of compliance risk, ranging from Medicare reimbursement and billing concerns to informed consent and use of equipment and materials in clinical research
• Outline key components of compliance plans and specifics relevant to clinical research

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Key Compliance Issues In Clinical Research: What Sites, CROs, and Start-Ups Need to Know

  1. 1. Key Compliance Issues in Clinical Research What Sites, CROs, and Start-Ups Need to Know Ana Christian and Kelly Schulz December 14, 2016
  2. 2. Agenda  Parties Involved  Overview of Applicable Laws and Regulations  Key areas of Compliance Risk  Role of Compliance and Steps to Take Now
  3. 3. Parties Involved Bring a safe and effective product to marketSponsors • Site/investigator qualifications • Data integrity • Validate safety & efficacy Assist the sponsorCROs • Meet deadlines & sponsor expectations • Assume responsibility for sponsor regulatory obligations Protect patients and offer novel therapiesSites • Human subject protection • Patient care • Academic freedom & publication
  4. 4. Overview of Applicable Laws and Regulations
  5. 5. Agencies with Oversight  Office of Research Integrity  Office of Human Research Protections  National Institutes of Health, Office of Management Administration and Office of Extramural Research  Food and Drug Administration
  6. 6. Legal Landscape FDA & HHS Stark & AKS FCA HIPAA GCP Sunshine CMS
  7. 7. Potential Consequences of Non-Compliance  Federal exclusion or debarment  Civil monetary penalties  Application of criminal law  Breach of Clinical Trial Agreement (CTA)  Study subject lawsuits  Loss of funding  Damage to reputation
  8. 8. Key Areas of Compliance Risk 1. Billing Compliance 2. Informed Consent 3. Conflicts of Interest 4. Anti-Kickback
  9. 9. Billing Compliance  Clinical Trial Policy (CTP)  National coverage determination (NCD) issued on September 19, 2000 – "2000 Clinical Trial Policy.“  Reconsideration and issuance of final decision memorandum on July 9, 2007 that preserves the status quo of the 2000 CTP with a few exceptions.  On October 17, 2007, CMS closed the reconsideration with a final decision memorandum that retained the July 9, 2007 policy.  Medicare covers items and services that are “reasonable and necessary to diagnose or treat illness or injury”  Creates an issue with the Medicare coordination of benefits provisions
  10. 10. Billing Compliance – Common Pitfalls  Billing for services already paid by sponsor (double billing)  Billing for research-only services  Waiver of co-pays and deductibles
  11. 11. Billing Compliance – Mitigation  Establish processes and procedures to track which patients are enrolled in a study – Does your billing staff know that services are provided as part of a clinical trial?  Perform Medicare Coverage Analysis (MCA) and determine what can be properly submitted for reimbursement to Medicare  Do not bill CMS for items/services paid for by sponsor (double billing)  Watch for conflicting terms in the body of the CTA, the study budget and informed consent form
  12. 12. Informed Consent  HHS & FDA regulations at 45 CFR Part 46 and 21 CFR Parts 50  Informed Consent Information Sheet: Draft Guidance for IRBs, Clinical Investigators, and Sponsors, last updated July, 2014, available at: http://www.fda.gov/downloads/RegulatoryInformation/Guida nces/UCM405006.pdf  Use of Electronic Informed Consent in Clinical Investigations Questions and Answers, Draft Guidance for Industry, last updated March, 2015, available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceR egulatoryInformation/Guidances/UCM436811.pdf
  13. 13. HIPAA  HIPAA Privacy Rule governs the use and disclosure by Covered Entities of Protected Health Information in research  Covered Entities may use and/or disclose PHI to sponsors/researchers either through: Patient authorization (45 CFR 164.508) Waiver by an IRB (45 CFR 46.117(c)-(d))

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