Global views on clinical trials and data quality / 药学学报
Acta Pharmaceutica Sinica
;
(12): 1434-1442, 2015.
Article
Dans Chinois
| WPRIM
| ID: wpr-320062
ABSTRACT
The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
Sujet Principal:
Normes de référence
/
Reproductibilité des résultats
/
Essais cliniques comme sujet
/
Exactitude des données
Type d'étude:
Guide de pratique
langue:
Chinois
Texte intégral:
Acta Pharmaceutica Sinica
Année:
2015
Type:
Article
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