2022 Research Compliance Conference

1. It's Not Research, It's Quality Improvement

   2022 Research Compliance Conference  | June 08, 2022 

   • Discuss the differences between research and quality improvement activities

   • Examine OHRP's guidance on quality improvement and the revised Common Rule exemptions

   • Explore case examples where organizations successfully navigated quality improvement and research differences

2. Oh My! The Unique Challenges of Monitoring Investigator Initiated Trials (IITs)

   2022 Research Compliance Conference  | June 08, 2022 

   • Identify the unique regulatory and operational challenges of monitoring IITs

   • Learn the key components of monitoring IITs including remote risk-based monitoring

   • Discuss the strategies to address operational challenges of monitoring IITs and share lessons learned from a designated cancer center

3. Managing Conflict of Interest Risk in Academic Medical Centers: Beyond Regulations and Form Collections for Investigators

   2022 Research Compliance Conference  | June 08, 2022 

   • Managing conflicts, compliance, and reputational risks: Governance and senior leadership issues

   • Technology, data collaboration and transfer-startups, joint ventures, and faculty entrepreneurs

   • Managing COI systems: Required disclosures, privacy and confidentiality, thinking about users, reporters, certifications, committees, regulators, grantors, and audits

4. Sponsor Clinical Quality Assurance Audits of Investigator Sites: Readiness, Response, and CAPAs

   2022 Research Compliance Conference  | June 08, 2022 

   • Understand authority, purpose, and framework for sponsor CQA audit programs (including Investigator-Sponsors)

   • Discuss site audit readiness throughout study conduct and for the audit

   • Discuss audit process, sponsor observations, site responses, quality CAPAs

5. Building an Effective Export Control Program within an Evolving Research Environment

   2022 Research Compliance Conference  | June 08, 2022 

   • Strategize and coordinate export control activities within a biomedical research institution

   • Define key components of an effective export control program

   • Communicating export control effectively with researchers

6. Best Practice Approaches to Building an Effective Research Billing Compliance Audit Program

   2022 Research Compliance Conference  | June 08, 2022 

   • Identify the operational front-end and back-end processes necessary to set the foundation for successful research billing compliance audit outcomes

   • Describe how collaboration is key to building an effective audit program

   • Discuss strategies to identify red flags and hot issues that could put your site at risk for research billing non-compliance before being discovered in an audit

7. Clinical Trials in a Virtual World: A Case Study Analysis of Compliance Risks in Decentralized Clinical Trials

   2022 Research Compliance Conference  | June 08, 2022 

   • Identify regulatory and legal hurdles for structuring and running virtual clinical trials

   • Devise risk mitigation strategies to combat compliance challenges in decentralized clinical trials

   • Implement best practices for protecting research subjects' data privacy and security

8. Hot FDA Compliance Issues for 2022

   2022 Research Compliance Conference  | June 08, 2022 

   • Learn what FDA is focused on this year in assessing and assuring compliance of medical device clinical investigations.

   • What types of device clinical investigation violations are triggering compliance letters and enforcement actions?

   • What should you do to meet FDA expectations and avoid regulatory problems in this area?
     

9. General Session: Research Year in Review 2022

   2022 Research Compliance Conference  | June 09, 2022 

   • This session will present relevant new laws, regulations, and guidance from federal and state government agencies on the conduct of research; and

   • We will review new OIG Workplan and it's research initiatives as well as key enforcement initiatives and settlements related to research.

   • We will discuss novel approaches to addressing these new government initiatives within research compliance programs.

10. Research Billing Compliance: A Case Study at Renown Health Using the Epic Research Module

    2022 Research Compliance Conference  | June 09, 2022 

    • Making it work and work compliantly: Launching the Epic Research Module

    • Collaborating and engaging multiple stakeholder: Who, when, where, how, and what

    • After launching, the importance of continuous review and updating standards of work

11. Use of Data from Non-Traditional Sources to Conduct Human Research: Emerging Ethical and Compliance Considerations

    2022 Research Compliance Conference  | June 09, 2022 

    • Develop knowledge and understanding of emerging sources of data used in human subject research

    • Understand ethical and regulatory issues in collection and use of data from nontraditional sources

    • Equip Research Compliance Officers to apply the knowledge gained to strengthen compliance programs and train stakeholders in order to support growing strategic needs within organizations to adopt use of data driven human research

12. How to Get (More) Bang for Your Buck! Developing & Executing Good Clinical Practice (GCP) & Research Billing Audit Plans from Practical Risk Assessments

    2022 Research Compliance Conference  | June 09, 2022 

    • Discuss strategies for developing risk based audit plans using thoughtful and pragmatic risk assessments, sampling/ testing techniques, and internal versus external auditors

    • Examine nuances of "process audits" versus audits of individual studies, including phase one studies and investigator-initiated trials

    • Share success stories and lessons learned conducting risk assessments, GCP, and billing audits

13. Handling MultiFaceted Investigations Related to Research

    2022 Research Compliance Conference  | June 09, 2022 

    • How to conduct an effective internal investigation in research compliance despite slippery slopes

    • How to deal with the phenomenon of "expecting the unexpected"

    • What to do to help prepare your institution for public scrutiny caused by the investigation

14. A Hidden Minefield? Navigating Legal and Compliance Risks in Research Budgeting and Compensation

    2022 Research Compliance Conference  | June 09, 2022 

    • In depth review of legal and regulatory risks in requesting, allocating, and paying research dollars

    • Discussion of recent enforcement actions and litigation that illustrate risks related to improper budgeting and payments

    • Ten tips for a compliance process that mitigates risk

15. Complexities of Data Sharing with External Researchers

    2022 Research Compliance Conference  | June 09, 2022 

    • Understand the background for undue influence concerns and the tension research security measures can create with open scientific collaborations

    • Understand the regulatory and institutional reasons why data security measures are necessary.

    • Learn about the complexity of implementing enterprise-wide changes and the intricacies of managing multiple stakeholders to enable a procedural change

16. Instituting Improvement and Quality Assurance in an Animal Care and Use Program in Transition

    2022 Research Compliance Conference  | June 09, 2022 

    • Identifying program concerns through subject matter expert collaboration and coordination

    • Standardizing practices and promoting education and training to create consistency

    • Crafting a quality assurance program to embed improvements into the culture

17. Increasing Diversity in Clinical Research

    2022 Research Compliance Conference  | June 09, 2022 

    • Identifying and understanding the importance and benefits of diversity in research

    • Discuss recent FDA/NIH/state/industry guidance for addressing diversity in research

    • Strategies for increasing diversity to meet laws, guidance and requirements

18. CMS Open Payments Expansion: Impacts to Research Conflicts of Interest

    2022 Research Compliance Conference  | June 09, 2022 

    • Understand what has changed under the CMS Open Payments Expansion

    • Explore how the HHS OIG identifies and investigates high-risk industry-provider relationships

    • Discuss practical tips on incorporating CMS Open Payments review into research COI processes

19. It's Not You, It's Me: Building and Maintaining Trust between Research Compliance or Administration Offices and the Research Community

    2022 Research Compliance Conference  | June 09, 2022 

    • Identify and discuss the importance of trust, respect, and legitimacy in the relationship between researchers and research compliance and administration offices

    • Identify best practices for building trust, respect, and legitimacy between the researcher community and research compliance and administration offices

    • Explore what participant offices can do to enhance trust/respect in their institution between the research community and research compliance and administration offices

20. General Session: OHRP Compliance Update: Hot Topics

    2022 Research Compliance Conference  | June 10, 2022 

    • What's new with OHRP's implementation of the revised Common Rule

    • An overview of regulatory flexibilities pertinent to research conducted during the COVID-19 pandemic

    • Update on OHRP's compliance oversight activities

21. Managing COI Compliance: The Importance of Disclosures in Publications & Presentations

    2022 Research Compliance Conference  | June 10, 2022 

    • Review compliance concerns with nondisclosure, including public opinion and backlash

    • Understand current journal, association, and institutional requirements for COI disclosures

    • Learn how to implement training and review processes to ensure compliance for COI disclosures

22. Data Use in Research: Limitations, Obligations, Myths, and Mysteries

    2022 Research Compliance Conference  | June 10, 2022 

    • Discussion of continued myths around the use and disclosure of data for research

    • Overview of the limitations and obligations on the use and disclosure of data for research

    • Myths and mysteries regarding the impact of the ONC Information Blocking Rule on acquiring data for research.

23. Expanding the Plan: Integrating Research Compliance Risk Assessments into Existing Monitoring Programs

    2022 Research Compliance Conference  | June 10, 2022 

    • Integrating research compliance risk assessments into existing compliance monitoring programs

    • Discuss considerations, priorities, and options with operationalizing a risk assessment plan

    • Communicating results of work, developing targeted training, and education

24. NIST Cybersecurity Framework = A Credible & Prescriptive Standard

    2022 Research Compliance Conference  | June 10, 2022 

    • Establishing an evidence-based program based NIST standards

    • Achieving CMMC Certification, a new DoD cyber standard based on NIST

    • Managing the cyber supply chain to mitigate risk from business associates and third parties

25. Point of Care Training for Research Coordinators

    2022 Research Compliance Conference  | June 10, 2022 

    • Explore a point of care or pocket training for study coordinators

    • Optimize efficiencies and increase patient safety

    • Define new strategies for training