2020 Virtual Research Compliance Conference

  1. Wish I Had Known That a Year Ago": Lessons Learned in the Midst of Conducting a Research Misconduct Inquiry and Investigation

    2020 Virtual Research Compliance Conference  | Presenter(s): Darri Scalzo, Nancy Rhea  | June 03, 2020 

    • This session will include a discussion of regulatory guidance on misconduct proceedings, as well as detailed information related to conducting inquiries and investigations of research misconduct

    • Additional discussion points include mistakes to avoid and best practices to help the audience members become more prepared to take on a research misconduct inquiry and investigation

    • Steps to help the audience members be prepared before getting the dreaded “I think we have a problem” call and tips for encouraging a culture of integrity and compliance at your institution

  2. Demonstrating Good Clinical Practice (GCP) Compliance in Research Through the Maintenance of Regulatory Documents

    2020 Virtual Research Compliance Conference  | Presenter(s): Christina Jackson  | June 03, 2020 

    • Discussion of the 13 Principles of ICH GCP Guidelines Identify Regulatory Documents to Maintain

    • Recognizing the Most Common Deficiencies in Regulatory Documentation

    • Moving from Paper to a Digital Environment

  3. CRRC: Clinical Research Revenue Cycle Management: Avoiding the Pitfalls

    2020 Virtual Research Compliance Conference  | Presenter(s): Mary Veazie, Erika Stevens  | June 02, 2020 

    • This session describes leading practices for establishing a clinical research revenue cycle CCRC, explores the regulatory landscape, identifies processes for implementing appropriate safeguards for risk mitigation, and applies methods for CCRC management

    • Apply proven methods, such as data analytics and tracking trial performance trends, to improve CCRC program success and promote accountability

    • Analyze lessons learned, leading practices, proven tools and implementation methods from a recent case study

  4. Compliance Officer's Research Data Nightmare and How to Wake Up From It

    2020 Virtual Research Compliance Conference  | Presenter(s): Ashley Huntington, Leyla Erkan, Melissa Mitchell  | June 02, 2020 

    • Compliance officers in the research sphere play a significant role in protecting PHI and other forms of health data as it flows into from organizations to research and beyond, which often raises significant privacy issues

    • We will discuss the privacy issues that arise in this cycle; including using data to recruit patients; communicating on and triaging issues when deviations in research occur and how, when, and why data is shared beyond the scope of research

    • We will focus specifically on trends in how data are handled, potentially manipulated and shared, and how compliance can best partner with other departments across the organization to support this function while still safeguarding patient information

  5. Protecting Research Participants Financially: Making SENSE of Patient-CENTric Research When Patients Lack CENTS

    2020 Virtual Research Compliance Conference  | Presenter(s): Geoffrey Schick  | June 02, 2020 

    • Explore challenges for participants in clinical trials when the patient is indigent or has high out-of-pocket expenses due to their commercial healthcare insurance policy. Explore effects from Medicare secondary payer, anti-kickback statutes, etc.

    • Investigate the challenges of participating in sponsor-provided “Financial Hardship Programs” designed to help research participants with financial obligations

    • Discuss opportunities to create a vehicle for the research entity to assist clinical trial participants through relationships with foundations. What are the benefits/risks of a program running side by side with existing charity care programs?

  6. Unity is Strength: Research Compliance Through Leadership

    2020 Virtual Research Compliance Conference  | Presenter(s): David Staley  | June 02, 2020 

    • Identify your bundle of sticks as a leader in research compliance

    • Frame a culture of research compliance by engaging with others, making commitments, and being present

    • Construct tools that empower compliance leaders in bringing what matters to a collaborative space

  7. RESEARCH COMPLIANCE GENERAL SESSION: "Research Compliance During the Pandemic" - A Round Table

    2020 Virtual Research Compliance Conference  | Presenter(s): Lisa Murtha, Ryan Meade, Lynn Batholow, Sarah Duffy-Clinton  | June 02, 2020 

    • Examine rapid study start-up

    • Discuss human subject protection safeguards during a crisis

    • Review emergency use FDA rules

  8. Compliance and Culture: How Design and Approach Can Help Support Clinical Trial Billing

    2020 Virtual Research Compliance Conference  | Presenter(s): Kelly Willenberg, Tracy Popp  | June 01, 2020 

    • Elevate your billing compliance program while building morale of stakeholders with ROI through research related billing reviews

    • Describe how to gain buy-in for an understanding of the ADVANCED risks related to research billing such as payer issues, off-label drugs, CART-T, etc.

    • Discuss approach of self-monitoring and auditing of billing compliance that is authentic to the culture you have built

  9. Stop! Or Else I''ll Say Stop Again! Institutional Responses to COI Noncompliance

    2020 Virtual Research Compliance Conference  | Presenter(s): Craig Conway  | June 01, 2020 

    • An interactive session designed to share ideas and best practices

    • How do institutions respond when faculty members or employees intentionally or unintentionally fail to adhere to federal, state, or institutional COI requirements?

    • This session will seek to identify common COI noncompliance areas We will provide strategies and recommendations for handling COI noncompliance that participants may take back to their respective institutions

  10. GENERAL SESSION: Research Year in Review

    2020 Virtual Research Compliance Conference  | Presenter(s): Lisa Murtha  | June 01, 2020 

    • This session is designed to cover all new laws, regulations and guidance promulgated by the government in the area of research

    • The session will outline new research related enforcement initiatives and settlements by the Department of Justice and the Office of Inspector General

    • The speaker will describe the implications of these laws, regulations and guidance on research programs and will suggest affirmative actions to be considered to strengthen research compliance programs for universities, academic medical centers, hospitals, CROs and other research organizations