Overview of CDISC standard and implementation in China / 药学学报
Acta Pharmaceutica Sinica
; (12): 1428-1433, 2015.
Article
en Zh
| WPRIM
| ID: wpr-320063
Biblioteca responsable:
WPRO
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.
Texto completo:
1
Base de datos:
WPRIM
Asunto principal:
Estándares de Referencia
/
China
/
Recolección de Datos
/
Ensayos Clínicos como Asunto
/
Investigación Biomédica
Tipo de estudio:
Guideline
País/Región como asunto:
Asia
Idioma:
Zh
Revista:
Acta Pharmaceutica Sinica
Año:
2015
Tipo del documento:
Article