[Overview of CDISC standard and implementation in China].

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.

[The significance, development and prospects of healthcare data integration in new drug clinical trials].

With the deployment of electronic medical records systems, more and more routine clinical data are recorded electronically, which become a potential data source for new drug clinical trials. In this paper, we summarized the opportunities, challenges, obstacles and the latest development in this field.

[Source data management in clinical researches].

Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China.