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 The GAMP5 verification process and specifications of the clinical trial central randomization system was established according to the GAMP5 guideline and domestic and foreign computerized system verification guidelines and regulations in combination with the characteristics of the clinical trial central randomization system, and the existing clinical trials central randomization system was used 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. For the existing system, a verification team was established, a verification plan was developed, and a 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.
GENG Zheng, HUANG Jiajun, YU Hao, WEI Yongyue, CHEN Feng. The verification process and practice of the clinical trials central randomization system based on GAMP5 guideline. Chinese Journal of Evidence-Based Medicine, 2021, 21(7): 863-868. doi: 10.7507/1672-2531.202102054