Abstract: Objective To solve the existing problems with traditional paper-based data collection, such as poor security and liability, slow data aggregation and high cost, and to explore the application of the Electronic Data Capture (EDC) System and data safety monitoring. Methods An Electronic Data Capture (EDC) System was designed that was specifically used for vaccine clinical trials based on Chinese standards and requirements. With an integrated hardware and software solution, the man-machine system was able to collect and process data according to certain application Objectives and rules. Each of the functional modules was verified in a comprehensive, rigorous and standard way on one of the clinical trial sites in Guangxi. Results The system proved to be capable of recording and storing information, querying and verifying data, statistical analysis and data-derivation, which could ensure vaccine safety monitoring and data collection by means of online real-time monitoring of the subjects’ follow-up visit status and adverse events. Conclusion This EDC system can not only meet the needs of Chinese vaccine clinical trials and the second development, but provide a platform in support of large sample clinical trial monitoring and management as well as safety monitoring, thus layinga solid foundation for establishing systematic vaccine-drug pharmacovigilance systems.

Key words: electronic data capture system (EDC), vaccine clinical trial, safety, data quality