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2016-10-10
Guiding principles of electronic data acquisition technology in clinical trials

In recent years, with the rapid development of electronic data collection and data entry in clinical trials, more and more countries have adopted electronic data collection and paper-based data collection methods to improve the quality of clinical trials Sub data acquisition technology to ensure data quality.

In order to promote the integrity, accuracy, authenticity and reliability of electronic data in clinical trials in China, it is necessary to clearly explain the basic considerations and principles for the application of electronic data acquisition technology in clinical trials The purpose of this paper is to help and guide the relevant parties, including the sponsor, cro and clinical researchers, to standardize and reasonably apply EDI technology in clinical trials.