Comparison of paper and electronic data management in clinical trials / 药学学报
Acta Pharmaceutica Sinica
; (12): 1461-1463, 2015.
Article
em Zh
| WPRIM
| ID: wpr-320058
Biblioteca responsável:
WPRO
ABSTRACT
Electronic case report forms (eCRFs) instead of the traditional paper case report forms (pCRFs) are increasingly used by investigators and sponsors of clinical research. We include a total of 14 phase III studies (8 pCRF, 6 eCRF) to compare paper and electronic data documentation both quantitatively and qualitatively in clinical studies. The result suggests that adaptions of electronic data capture (EDC) in clinical trials have the advantages in optimization of data capture process, improvement of data quality and earlier clinical decision compared to paper-based methods. Furthermore, the successful implementation of EDC requires accouplements with corresponding data management processes and reallocation of resources.
Texto completo:
1
Índice:
WPRIM
Assunto principal:
Informática Médica
/
Coleta de Dados
/
Armazenamento e Recuperação da Informação
/
Ensaios Clínicos Fase III como Assunto
/
Métodos
Tipo de estudo:
Prognostic_studies
Idioma:
Zh
Revista:
Acta Pharmaceutica Sinica
Ano de publicação:
2015
Tipo de documento:
Article