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Session 1: General Requirements for Standardization
Session Chair(s)
Hideaki Ui, PhD
Poject Professor, Director of Dpt. of Clinical research Governance
The University of Tokyo, Japan
Makoto Yokobori
President
SUXAC Inc., Japan
“Standardization” is not a purpose but a tool. We always have to have a strong awareness whether it suits its purpose or not. In this session, we would like to discuss the required parts and quality for standardization after outlining the history of data standardization. We want to also consider the standardization of education as it is the most important matter for standardization process.
Speaker(s)
Opportunities, Challenges and Complexities of Sharing Clinical Research Data
Reza Rostami, MBA, RAC
Duke Clinical Research Institute, United States
Associate Director, Quality Management
Relationship of Quality and Standardization
Hideaki Ui, PhD
The University of Tokyo, Japan
Poject Professor, Director of Dpt. of Clinical research Governance
Challenge to Build a Standardized Method for Developing CDM
Takeshi Kawakami, MS
Pfizer R&D Japan G.K., Japan
Clincial Data Scientist, Data Monitoring & Management
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