Comparison of paper and electronic data management in clinical trials.
- Author:
Fang YIN
;
Jun-chao CHEN
;
Hong-xia LIU
;
Ying-chun HE
;
Qing-shan ZHENG
- Publication Type:Journal Article
- MeSH:
Clinical Trials, Phase III as Topic;
Data Collection;
methods;
Information Storage and Retrieval;
methods;
Medical Informatics
- From:
Acta Pharmaceutica Sinica
2015;50(11):1461-1463
- CountryChina
- Language:Chinese
-
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.
