China Food and Drug Administration Launches Steering Committee with C3C On 19 June 2013, the China Clinical Trial Data Standards Steering Committee (CTDS-SC) was established after a half-day workshop on data standards in Beijing. This committee was initiated by the Center for Drug Evaluation (CDE) of China FDA with the assistance from China CDISC Coordinating Committee (C3C). The purpose of the Steering Committee is to advocate for data standards in clinical trials in China, advise the working groups and provide policy recommendations to China FDA based on the working groups’ technical input. The Steering Committee set initial goals for the working groups for the 2nd half of year 2013 and 2014 including: 1) Chinese translation of the latest CDISC foundational standards, 2) at least one pilot study to test the Chinese version, and 3) technical recommendations for data standards in China.


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