Data quality in clinical trials: the role of blind review / 药学学报
Acta Pharmaceutica Sinica
;
(12): 1498-1501, 2015.
Artigo
em Chinês
| WPRIM
| ID: wpr-320050
ABSTRACT
Blind review is one of the most important milestones in clinical trials, which connects data management process to statistical analysis. During blind review, data quality should be reviewed and assessed on both data management and statistical aspects. The primary work of data managers in blind review is to ensure the accuracy of data before it is handed over to biostatistics group. Database auditing, listing data reviewing and reconciliation should become a good clinical data management practice. Statisticians, on the other hand, will focus on quality findings related to protocol deviations or protocol violations. To investigate the protocol deviations and/or violations and relevant impacts on data outcomes, it is important to provide the essential basis of data quality through the blind review, and to assess the reliability of study outcomes.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Bioestatística
/
Reprodutibilidade dos Testes
/
Ensaios Clínicos como Assunto
/
Bases de Dados Factuais
/
Confiabilidade dos Dados
Tipo de estudo:
Guia de Prática Clínica
Idioma:
Chinês
Revista:
Acta Pharmaceutica Sinica
Ano de publicação:
2015
Tipo de documento:
Artigo
Similares
MEDLINE
...
LILACS
LIS