June 8 - 10, 2022
Research Compliance Conference
Anaheim, CA, United StatesHandouts
WEDNESDAY, JUNE 8 (Pre-Conference)
P1 It’s Not Research, It’s Quality Improvement |
P2 Oh My! The Unique Challenges of Monitoring Investigator Initiated Trials (IITs) |
P3 Managing Conflict of Interest Risk in Academic Medical Centers: Beyond Regulations and Form Collections for Investigators |
P4 Sponsor Clinical Quality Assurance Audits of Investigator Sites: Readiness, Response, and CAPAs |
P5 Building an EffectiveExport Control Program within an Evolving Research Environment |
P6 Best Practice Approaches to Building an Effective Research Billing Compliance Audit Program |
P7 Clinical Trials in a Virtual World: A Case Study Analysis of Compliance Risks in Decentralized Clinical Trials |
P8 Hot FDA Compliance Issues for 2022 |
THURSDAY, JUNE 9
GENERAL SESSION: Research Year in Review |
101 Research Billing Compliance: A Case Study at Renown Health Using the Epic Research Module |
102 Use of Data from Non-Traditional Sources to Conduct Human Research: Emerging Ethical and Compliance Considerations |
103 How to Get (More) Bang for Your Buck! Developing & Executing Good Clinical Practice (GCP) & Research Billing Audit Plans from Practical Risk Assessments |
104 Handling Multi-Faceted Investigations Related to Research |
105 A Hidden Minefield? Navigating Legal and Compliance Risks in Research Budgeting and Compensation |
106 Complexities of Data Sharing with External Researchers |
107 Instituting Improvement and Quality Assurance in an Animal Care and Use Program in Transition |
108 Increasing Diversity in Clinical Research |
109 CMS Open Payments Expansion: Impacts to Research Conflicts of Interest |
110 It’s Not You, It’s Me: Building and Maintaining Trust between Research Compliance/Administration Offices and the Research Community |
FRIDAY, JUNE 10
GENERAL SESSION: OHRP Compliance Update: Hot Topics |
111 Managing COI Compliance: The Importance of Disclosures in Publications & Presentations |
112 Data Use in Research: Limitations, Obligations, Myths, and Mysteries |
113 Expanding the Plan: Integrating Research Compliance Risk Assessments into Existing Monitoring Programs |
114 NIST Cybersecurity Framework = A Credible & Prescriptive Standard |
115 Point of Care Training for Research Coordinators |
116 Optimizing a Conflict of Interest, Conflict of Commitment, and External Activities for Pay Reporting Process |
117 21st Century Cures Act: What Is It and How to Operationalize It |
118 Sponsor-Investigators of Medical Device Studies: Creating Front-Line Institutional Compliance Systems |
GENERAL SESSION: Navigating the Research Fraud and Abuse and Billing Rules |