Overview of global clinical data management regulations and standards / 药学学报
Acta Pharmaceutica Sinica
;
(12): 1443-51, 2015.
Artículo
en Chino
| WPRIM
| ID: wpr-505004
ABSTRACT
Quality and integrity of clinical trials and associated data management is a basis on the scientific and rightly assessments of drug safety and efficacy. While both normalization and standardization of clinical trial procedures assure quality of clinical trials and the relevant data processes, they will drive and improve the efficiency and reliability of real-world deliverables in clinical trials in turn. Currently, the comprehensive standards and practices of clinical trials and associated data management are globally established better, and US and EMA have enacted and implemented adequate guidances and regulations well. China is in the initial stage of development of relevant regulations regarding clinical trials and associated data management. This review will focus on the above-mentioned global regulations and standards of clinical data management in the views of good clinical data management standpoints, making references to improve the Chinese regulative system of clinical data management.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Tipo de estudio:
Guía de Práctica Clínica
Idioma:
Chino
Revista:
Acta Pharmaceutica Sinica
Año:
2015
Tipo del documento:
Artículo
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