• Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, P.R. China;
WEI Yongyue, Email: ywei@njmu.edu.cn; CHEN Feng, Email: fengchen@njmu.edu.cn
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Objective Through researching the “Automated Production Quality Management Specification 5th Edition” (GAMP5) promulgated by the International Society for Pharmaceutical Engineering, combined with domestic and foreign guidelines and regulatory requirements, to explore the practical methods for the verification of the central randomization system of clinical trials.Methods According to the GAMP5 guideline and domestic and foreign computerized system verification guidelines and regulations, combined with the characteristics of the clinical trial central randomization system, established the GAMP5 verification process and specifications of the clinical trial central randomization system, and took the existing clinical trials central randomization system as an example to show the verification results.Results The verification framework and process of the central randomization system met the requirements of the relevant regulations of clinical trials that had been constructed. Taking the existing system as an example, a verification team was established, a verification plan was developed, and computerized system verification was conducted in accordance with the V model to form a set of standardized verification documents.Conclusions The verification process of the central randomization system proposed by this research follows the GAMP5 specification and has high operability and reference value.