Quality control of clinical data management based on EDC.
- Author:
Hong-xia LIU
;
Ying-hua LV
;
Mao-sheng ZHOU
;
Qing-heng MENG
;
Jun-chao CHEN
;
Ying-chun HE
;
Qing-shan ZHENG
- Publication Type:Journal Article
- MeSH:
Clinical Trials as Topic;
Data Collection;
standards;
Information Storage and Retrieval;
standards;
Quality Control
- From:
Acta Pharmaceutica Sinica
2015;50(11):1470-1473
- CountryChina
- Language:Chinese
-
Abstract:
With the wide application of electronic data management (EDC), the data management is shifting to a new mode. In order to recognize the advantages of EDC, we choose 20 representative registered clinical trials, which involve 5 404 subjects and 321 sites. We found that EDC has many beneficial impacts on the course of clinical trial data management, including the process of data collection, data cleaning, data quality control and clinical trial decision-making. The result also provides a reference for the adoption of EDC in clinical trials.
