2022 Research Compliance Conference

  1. Optimizing a Conflict of Interest, Conflict of Commitment, and External Activities for Pay Reporting Process

    2022 Research Compliance Conference  | June 10, 2022 

    • Understand the difference and similarities in COI, COC, and EAP

    • Discuss common roadblocks that create inefficiencies

    • Learn how to coordinate reporting for the end users and reviewers

  2. 21st Century Cures Act: What Is It and How to Operationalize it

    2022 Research Compliance Conference  | June 10, 2022 

    • Describe the 21st Century Cures Act

    • Describe the 2020 amendment: Information blocking

    • Describe how it affects clinical research operations

  3. Sponsor-Investigators of Medical Device Studies: Creating Front-Line Institutional Compliance Systems

    2022 Research Compliance Conference  | June 10, 2022 

    • FDA regulations for clinical investigations with medical devices

    • Elements to assess prior to study initiation for regulatory compliance

    • An example of institutional level gatekeeping systems

  4. GENERAL SESSION: Navigating the Research Fraud and Abuse and Billing Rules

    2022 Research Compliance Conference  | June 10, 2022 

    • Review Medicare research-related services and clinical trial billing rules and common challenges

    • Explore anti-kickback, Stark Law, and patient inducement issues with provider and patient financial arrangements

    • Discuss strategies for identifying and addressing potential non-compliance