Day 1—Wednesday, March 6, 2024

10:00 a.m. – 10:15 a.m. Welcome
Susan Gregurick, PhD, NIH/OD/ODSS
10:15 a.m. – 10:45 a.m. Opening Keynote
Monica Bertagnolli, MD, NIH
10:45 a.m. – 11:15 a.m. Setting the Stage: Making Data Interoperable
Denise Warzel, MS, NIH/NCI
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.

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.

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

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.

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 Session

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
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.

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

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.

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, Data Solutions Sector, Westat

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.

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

3:30 p.m. – 4:00 p.m. Closing Keynote
Victoria Shanmugam, MBBS, MRCP, FACR, CCD, Office of Autoimmune Disease Research, NIH
4:00 p.m. – 4:15 p.m. Closing Remarks and Adjourn Day 2
Steve Tsang, PhD, NIH/OD/ODSS