Comparison of paper and electronic data management in clinical trials / 药学学报
Acta Pharmaceutica Sinica
; (12): 1461-1463, 2015.
Article
in Chinese
| WPRIM (Western Pacific)
| ID: wpr-320058
Responsible library:
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.
Full text:
Available
Database:
WPRIM (Western Pacific)
Main subject:
Medical Informatics
/
Data Collection
/
Information Storage and Retrieval
/
Clinical Trials, Phase III as Topic
/
Methods
Type of study:
Prognostic study
Language:
Chinese
Journal:
Acta Pharmaceutica Sinica
Year:
2015
Document type:
Article