#R1A

If I Knew Then What I Knew Now: Lessons from the Trenches on Building a Physician Practice Clinical Research Compliance Program Jennifer Sartor, Vice President, Compliance, National Spine and Pain Centers View Description

• Challenges and obstacles to developing the research compliance program
• Collaborative solutions that brought it all together
• Continuous improvement: How we are continuing to grow and evolve the research compliance program

Research Basic

#R1B

Electronic Systems in Clinical Research: How to Remain Compliant in the New "Virtual World" Candida Barlow, Clinical Research Informatics Nurse Specialist, Advarra Christine Nelson, Director, Office of Clinical Trials, University of North Carolina at Chapel Hill Laura Fluharty, Director, Clinical Research Operations, University of Pennsylvania View Description

Research Intermediate

#R2A

Bias and Structural Inequity in Research Mina Kini, System Director, Diversity and Inclusion, SSM Health Judith Burgan, Corporate Responsibility, SSM Health View Description

• Understand the history of bias and structural inequities in healthcare research. Most people know about the Tuskegee Syphilis Study. Explore other examples in the history of research where bias or structural inequity played a role
• Using data, describe the effects of bias and structural inequity on healthcare research today. From basic laboratory research to clinical trials, bias and structural inequities continue to affect research and the healthcare individuals receive
• List four strategies organizations can utilize to advance a culture of inclusion in research. Apply a strategy to improve diversity and inclusion in our workforces and engage with our communities

Research Basic

#R2B

Clinical Trials Research Compliance: Auditing vs Monitoring Jana Dock, Director, Research Business Operations, Mercy Research Geoffrey Schick, Senior Consultant, Site Strategy, WCG View Description

• Discuss the experience of Mercy's utilization of both auditing and monitoring in research compliance
• Identify the key elements of (external) auditing methodology and discuss pros and cons
• Identify the key elements of (internal) monitoring methodology and discuss pros and cons

Research Intermediate

#R3A

Complicated and Complex: Part C Medicare Advantage Billing for Clinical Trials Elizabeth Rodriguez, Associate Director, Johns Hopkins Medicine Scott Streibich, Director, Clinical Researcdh Revenue Integrity, Moffitt Cancer Center and Research Institute View Description

• Design research workflows supporting charging to Medicare Advantage or conventional Medicare
• Tackle complex research billing scenarios for clinical trials enrolling Medicare Advantage patients
• Clarify regulations related to trial type to include INDs, IDEs, CEDs, and LCDs

Research Intermediate

#R3B

Considerations in Building a Foreign Influence Compliance Program Janice Grace, Director, Office of Sponsored Projects Administrat, Mayo Clinic Kathleen McNaughton, Administrator, Mayo Clinic Will McIntire, Research Counsel, Boston Medical Center Callan Stein, Partner, Troutman Pepper Hamilton Sanders View Description

• Understand the Government’s (especially NIH, NSF, and DoD) recent focus on increased transparency concerning foreign elements and connections in applications for research grants
• Identify and overcome operational challenges to maintaining foreign influence compliance
• Mitigate legal exposure for investigators/ institutions by implementing an effective foreign influence compliance program

Research Intermediate

#R4A

Legal Update: Developments in Clinical Research, EUAs, and IRBs Tracy Field, Partner, Parker Hudson Rainer & Dobbs LLP Sandra Miller, Partner, Womble Bond Dickinson (US) LLP View Description

• Spotting informed consent issues, EUA approvals, and other issues in a pandemic
• Updated review of research subject disparities and practical ways to increase diversity in subjects
• Review recent government enforcement actions for research misconduct with ways to mitigate risk

Research Intermediate

#R4B

Privacy Considerations and AI in Medicine Mirena Taskova, Managing Director-Head of Privacy & Cybersecurity, Armanino Sarah Duffy-Clinton, Research Compliance Officer, Providence View Description

• Learn about solutions that will enable the rise of the next generation of AI in medicine
• Address privacy considerations if you use large amounts of data from healthcare machines
• Learn about the role of the stringent global privacy laws GDPR (Europe) and HIPAA (USA) in medicine

Research Intermediate