Advancing the Use and Development of Common Data Elements in Research Workshop

Agenda

Day 1—Wednesday, March 6, 2024

10:00 a.m. – 10:15 a.m.	Welcome Susan Gregurick, PhD, NIH/OD/ODSS View Session
10:15 a.m. – 10:45 a.m.	Opening Keynote Monica Bertagnolli, MD, NIH View Session
10:45 a.m. – 11:15 a.m.	Setting the Stage: Making Data Interoperable Denise Warzel, MS, NIH/NCI View Session
	Break
11:30 a.m. – 1:00 p.m.	Session I: The Value of Common Data Elements (CDEs) This session aims to highlight the value of CDEs in enhancing research efficiency across various HHS agencies. This session will explore how CDEs play a crucial role in standardizing data collection methods, promoting consistency across studies, enabling comparisons between different studies with validated instruments. View Session Moderator Anupama Gururaj, PhD, NIH/NIAID Session Topics How Biomedical Ontologies Overlap with CDEs and Contribute to Harmonization Richard Scheuermann, PhD, NIH/NLM Use of CDISC Data Standards at the FDA Helena Sviglin, MPH, CDER Office of Strategic Policy, Food and Drug Administration (FDA) Garbage in, Garbage Out: Standardized data for Better Reuse Avinash Shanbhag, MS, Office of Technology, Office of the National Coordinator for Health Information Technology (ONC) Common Data Elements: A Healthy People Perspective Allan Uribe, DrPH, MPH, CPH, National Center for Health Statistics, Centers for Disease Control (CDC) Q&A Session
	Lunch Break
2:00 p.m. – 3:00 p.m.	Session II: Current NIH Resources for CDEs This session will dive into the policies, trans-NIH initiatives, and resources for the identification and utilization of CDEs. Participants will have the opportunity to explore NIH resources that facilitate the location and incorporation of CDEs into their research projects that can foster greater efficiency, transparency, and reproducibility in their research. View Session Moderator Matthew McAuliffe, PhD, NIH/CIT Session Topics Overview of the NIH CDE Repository, CDE Governance Committee, and RFI Robin Taylor, MLIS, NIH/NLM Q&A Panel Session The NIH CDE Governance Committee Carolina Mendoza-Puccini, NIH/NINDS Kenneth Wilkins, NIH/NIDDK Robin Taylor, MLIS, NIH/NLM
	Break
3:15 p.m. – 4:30 p.m.	Session III: Overcoming Barriers in CDE Adoption, Mapping, and Use in Community Research This session will center on the significance and importance of community engagement throughout the CDE development and implementation process. Panel experts will discuss the strategies for strategy for developing, adopting, mapping, and using CDEs in community-based research, while also addressing the challenges encountered and strategies for overcoming them, while contributing to national or program level data repositories. View Session Moderator Deborah Duran, PhD, NIH/NIMHD Session Topics RADx® Underserved Populations - CDEs Warren A. Kibbe, PhD, FACMI, Duke University Seeking Community Feedback in the Development of Autoimmune and Immune Mediated CDEs Sirimon O'Charoen, PhD, Crohn's & Colitis Foundation Social Determinants of Health Common Data Elements in the NIMHD Health Equity Action Network (HEAN) Stuart Gansky, DrPH, MS, UC San Francisco Q&A SessionShruti Sehgal
4:30 p.m.	Adjourn Day 1

Day 2—Thursday, March 7, 2024

10:00 a.m. – 10:05 a.m	Welcome Back and Recap of Day 1 Steve Tsang, PhD, NIH/OD/ODSS View Session
10:05 a.m. – 11:20 a.m.	Session IV: Technical Implementation Aspects of Mapping, Transformation and Harmonization During this session, attendees will explore the technical implementation aspects of mapping, transforming, and harmonizing data, learning from experts that have navigated various challenges in this process. View Session Moderator Anthony Juehne, MPH, NIH/OD Session Topics NIAID Food Allergy Data Dictionary and CDEs Shruti Sehgal, MD (Hom.), MS, Northwestern Feinberg School of Medicine Making the "Common" in CDEs More Common Anne E. Thessen, PhD, University of Colorado Anschutz Medical Campus NMDP: Harmonizing Data Through Common Data Elements Kathleen Malum, BA, NMDP Q&A Session
	Break
11:30 a.m. – 1:00 p.m.	Session V: Approaches to Improve Interoperability This session will spotlight approaches and challenges to utilize CDEs to facilitate and improve data interoperability and support mapping and transformation. View Session Moderator Denise Warzel, MSc, NIH/NCI Session Topics Leveraging REDCap for Finding and Reusing CDEs for Making Data Interoperable Paul Harris, PhD, FACMI, FIAHSI, Vanderbilt University Medical Center Implementation of NINDS CDEs: Lessons Learned Jocelyn Craven, MPH, Medical University of South Carolina & Sara Meyer, Medical University of South Carolina Motivations, Challenges and Benefits of Building and Deploying the NCI Clinical Trials Evaluation Program (CTEP) CDEs Ginger Riley, Westat Using CDEs to Enable Harmonization of Common Data Models (CDMs) Kenneth Gersing, MD, NIH/NCATS Q&A Session
	Lunch Break
2:00 p.m. – 3:15 p.m.	Session VI: Use Cases for Preparing and Applying CDEs for Intelligent Technologies This session will explore the importance of preparing CDEs and data for AI applications and leveraging AI to enhance CDE definition and development. Experts will discuss opportunities in using AI, challenges such as addressing biases in AI-driven data aggregation, and the future of AI in data interoperability. View Session Moderator Kenneth Wilkins, PhD, NIH/NIDDK Session Topics Science Collaborative for Health Disparities and Artificial Intelligence Bias REduction (ScHARe) AI Use Cases Deborah Duran, PhD, NIH/NIMHD Defining/developing CDEs for use in AI/ML Applications for Clinical Research with Electronic Health Record Data Katherine P. Liao, MD, MPH, Harvard Medical School The Possibilities and Challenges of Using CDEs in Making Data AI-ready and the Future of AI In Achieving Data Interoperability Sally Baxter, MD, MSc, UC San Diego School of Medicine Q&A Session
	Break
3:30 p.m. – 4:00 p.m.	Closing Keynote Victoria Shanmugam, MBBS, MRCP, FACR, CCD, Office of Autoimmune Disease Research, NIH View Session
4:00 p.m. – 4:15 p.m.	Closing Remarks and Adjourn Day 2 Steve Tsang, PhD, NIH/OD/ODSS View Session