The verification process and practice of the clinical trials central randomization system based on GAMP5 guideline_Chinese Journal of Evidence-Based Medicine

Authors：

GENG Zheng , HUANG Jiajun , YU Hao ,  WEI Yongyue ,  CHEN Feng

Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, P.R. China;

Corresponding author：

WEI Yongyue, Email: ywei@njmu.edu.cn; CHEN Feng, Email: fengchen@njmu.edu.cn

Keywords：

Clinical trial; Randomization system; Computerized system; GAMP5; System verification

DOI：

10.7507/1672-2531.202102054

Video：

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Objective Through researching the "Automated Production Quality Management Specification 5^th 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.

Citation： 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 Copy

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13.	楼伟刚. GAMP5解读与仪器研发应用实践. 上海: 上海交通大学, 2015.
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23.	颜崇超, 陈峰, 夏结来, 等. 临床试验中计算机化系统的验证. 药学学报, 2015, 50(11): 1380-1387.
24.	孙杰, 陈君超, 刘红霞, 等. 基于电子化临床数据采集平台的中央随机系统特点及应用. 中国新药与临床杂志, 2010, 29(9): 711-715.
25.	陆振宇, 徐秀卉, 徐蓉, 等. ERP+CSV在制药企业中的实施应用. 中国医药工业杂志, 2019, 50(12): 1498-1508.
26.	EMA. Notice to sponsors on validation and qualification of computerised systems used in clinical trials, 2020. Available at: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-sponsors-validation-qualification-computerised-systems-used-clinical-trials_en.pdf.

1. Fisher RA. The design of experiments. London: Oliver and Boyd, 1960.
2. 陈君超, 何迎春, 陈欢, 等. 随机化方法与技术在当前临床试验中的应用. 中国新药杂志, 2019, 28(13): 1582-1586.
3. 刘雅琦, 刘曼, 刘玉秀, 等. 《新英格兰医学杂志》临床试验随机化方法应用状况评价. 中国循证医学杂志, 2021, 21(3): 303-307.
4. 刘红霞, 孙杰, 李兴珊, 等. 基于网络的随机化系统在临床试验中的应用及其评价. 中国新药杂志, 2010, 19(8): 657-661.
5. 刘保延, 文天才, 姚晨, 等. 多中心临床试验中的中央随机系统研究. 中国新药与临床杂志, 2006, 25(12): 931-934.
6. ISPE. GAMP5: a risk-based approach to complicant GXP computerized systems, 2008. Available at: https://ispe.org/publications/guidance-documents/gamp-5.
7. FDA. General principle of software validation, 2002. Available at: https://www.fda.gov/media/73141/download.
8. EU. GMP annex 11 computerised systems, 2011. Available at: https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-4/annex11_01-2011_en.pdf.
9. EU. GMP annex 15 qualification and validation, 2015. Available at: https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-4/2015-10_annex15.pdf.
10. 国家食品药品监督管理总局. 药物临床试验管理规范, 附录: 计算机化系统, 2015. Available at: https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20150526120001509.html.
11. 国家食品药品监督管理总局. 药物临床试验管理规范, 附录: 确认与验证, 2015. Available at: https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20150526120001509.html.
12. 汤继亮. GAMP5的基本概念和内容简介. 医药工程设计, 2012, 33(4): 43-50.
13. 楼伟刚. GAMP5解读与仪器研发应用实践. 上海: 上海交通大学, 2015.
14. 曾英, 王悦丰. 制药企业遵循GAMP5的计算机化系统验证实践探讨. 上海医药, 2011, 32(8): 403-405.
15. 朱丽娜. 临床试验电子数据采集系统验证的应用研究. 广州: 暨南大学, 2017.
16. 沈忱, 陆振宇, 徐秀卉, 等. 基于GAMP5的计算机化系统验证的实际应用. 中国医药工业杂志, 2018, 49(8): 1195-1202.
17. 朱玉洁, 李丽, 周莉莉. 基于GAMP5的药物临床试验计算机化系统验证的实证研究. 中国卫生产业, 2018, 15(4): 151-153.
18. 路佳特. 计算机化系统验证方法探讨. 中国医药工业杂志, 2017, 48(12): 1818-1821.
19. 李科, 闵旸. 风险评估在计算机化系统验证中的应用. 2017年(第七届)药物毒理学年会, 2017.
20. 胡勇. 网络信息系统风险评估方法研究. 成都: 四川大学, 2007.
21. Curtis S, Flower R, Emanuel-Kole L, et al. Failure modes and effect analysis to assess COVID-19 protocols in the management of obstetric emergencies. BMJ Simulation and Technology Enhanced Learning, 2020. DOI: 10.1136/bmjstel-2020-000747.
22. Mohanty JK, Dash PR, Pradhan PK. FMECA analysis and condition monitoring of critical equipments in super thermal power plant. Int J Syst Assur Eng Manag, 2020, 11: 583-599.
23. 颜崇超, 陈峰, 夏结来, 等. 临床试验中计算机化系统的验证. 药学学报, 2015, 50(11): 1380-1387.
24. 孙杰, 陈君超, 刘红霞, 等. 基于电子化临床数据采集平台的中央随机系统特点及应用. 中国新药与临床杂志, 2010, 29(9): 711-715.
25. 陆振宇, 徐秀卉, 徐蓉, 等. ERP+CSV在制药企业中的实施应用. 中国医药工业杂志, 2019, 50(12): 1498-1508.
26. EMA. Notice to sponsors on validation and qualification of computerised systems used in clinical trials, 2020. Available at: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-sponsors-validation-qualification-computerised-systems-used-clinical-trials_en.pdf.

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The verification process and practice of the clinical trials central randomization system based on GAMP5 guideline

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