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Managing Data at Arms' Length: China
Session Chair(s)
Ralph Douglas Harkins, PHD
Senior Statistical Consultant and Project Manager
RDH Statistical Consulting Service, United States
This forum will focus on CFDA-approved sites, data generation and reporting, electronic data capture, and the role of clinical research coordinators, clinical research associates, and other data management professionals in Chinese clinical trials.
Learning Objective : Discuss the role of CRAs, CRCs, QA, CTAs, data audits, quality control and data managers in clinical trials conducted in China.
Speaker(s)
CFDA Regulatory Processes
Ivan Yu Zhai, MD, MBA
GCP ClinPlus Co., Ltd., China
CEO
Data Monitoring at Arms' Length
Ethel Kagan, RN
Innovations Clinical Research, LLC, United States
President
Drug Safety Monitoring at Arms' Length
Barton L. Cobert, MD, FACP
BLCMD Associates, LLC, United States
President