Data Standards in Clinical Trials: Maximizing Innovation by Standardizing

Part I. Data Standards 101:

What are data standards?
What is the value?
How are data standards developed?
How do standards for electronic health records relate to those for clinical trials?


Welcome and Overview

Richard Hodes (Director, NIA)

Data Standards: What Are They and Who Needs Them?

Carolyn Compton (Former CEO, C-Path)

Global Clinical Research Standards from Protocol through Analysis/Reporting

Rebecca Kush (CEO, CDISC)

Data Standards for Electronic Health Records

Doug Fridsma (Chief Scientist and Director of Science and Technology, ONC/HHS)

Creating Common Data Elements for Neurologic Diseases

Petra Kaufman (Director, Office of Clinical Research, NINDS)

Practical considerations for data aggregation and interoperability

George Komatsoulis (Director, CBIIT, NCI)


Part II. FDA Perspective and NIH Experience with Data Standards in Clinical Trials


Regulatory Perspective on Data Standards in Clinical Trials

Mary Ann Slack (Deputy Director, OPI, CDER, FDA)

Leveraging High Quality Standard Data to Benefit the Public Health
Chuck Cooper (Medical Officer, Office of Translational Sciences, CDER, FDA)

Toward Greater Commonality in Collecting and Reporting Clinical Research Data: NIH Efforts

Jerry Sheehan (Assistant Director for Policy Development, NLM)

Instituting Data Standards for the National Children’s Study

John Lumpkin (Project Officer, Informatics Office, NICHD)

Controlled Terminologies and Data Standards

Margaret Haber (Co-Director, Enterprise Vocabulary Services, NCI)

Applying Data Standards for the DAIDS Clinical Trial Network

Scott Proestel (Acting Director, OPCRO, NIAID)

Data Standards in the CTSA Program

Elaine Collier (Director, OPCSA, NCATS)