title: [Overview of CDISC standard and implementation in China].
abstract: CDISC standard has become a set of global data standards that can be used in clinical study, covering the full life cycle of clinical researches. After nearly 20 years of development and continuous version upgrades, CDISC standard can improve the quality and efficiency of clinical research and drug review, and to facilitate all stakeholders involved in researches to exchange the study data and communicate the outcomes. CDISC standard has been or is to be adopted as standard format in data submission by multiple regulatory authorities, and more widely implemented by the global pharmaceutical community. CDISC standard is gradually adopted in China. The feasibility and roadmap of CDISC standard as the Chinese data submission format requirements are undergoing exploration and piloting further.
authors.forename: Victor
authors.initials: V
authors.lastname: Wu
authors.forename: Wen-Jun
authors.initials: WJ
authors.lastname: Bao
authors.forename: John
authors.initials: J
authors.lastname: Wang
authors.forename: Rui-Ling
authors.initials: RL
authors.lastname: Peng
authors.forename: Ya-Zhong
authors.initials: YZ
authors.lastname: Deng
authors.forename: Zi-Bao
authors.initials: ZB
authors.lastname: Zhang
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D002681:China; D002986:Clinical Trials as Topic / Q000592:standards*; D003625:Data Collection / Q000592:standards