[Quality control of clinical data management based on EDC]

Yao Xue Xue Bao. 2015 Nov;50(11):1470-3.
[Article in 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.

MeSH terms

  • Clinical Trials as Topic*
  • Data Collection / standards*
  • Information Storage and Retrieval / standards*
  • Quality Control