Back to Agenda
Session 0407: DATA STANDARDIZATION IN CLINICAL RESEARCH: CDISC STANDARDS AND IMPLEMENTATION
Session Chair(s)
Zibao ZHANG, PhD
Associate Director
PPD, China
Data standardization is considered as a critical factor in improving the overall effectiveness and efficiency in clinical research and the regulatory review process. This session will provide an overview of commitments to the use of open, consensus-based data standards from regulatory, community and industry. The topics will include the recent updates in data standardization from Chinese regulatory authority, and key issues, policy and guidance related to standardized study data; opportunities and challenges for regulatory and industry to ensure success in this area. Last, case studies will be shared by the standard development organization and the industry.
Speaker(s)
Representative Invited
CDE, Taiwan
Why CDISC Standards Make Difference in Clinical Data Quality and Efficiency
Rebecca Daniels Kush, PhD
Elligo Health Research, United States
President, Catalysis; Chief Scientific Officer
Standard-Based Real Time Data Analysis and Reporting – Is It a Dream or Reality
Nik Morton, MS
Catalyst Clinical Research, United States
Chief Operating Officer
Have an account?