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)