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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16.	沈忱, 陸振宇, 徐秀卉, 等. 基于GAMP5的計算機化系統驗證的實際應用. 中國醫藥工業雜志, 2018, 49(8): 1195-1202.
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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.	顏崇超, 陳峰, 夏結來, 等. 臨床試驗中計算機化系統的驗證. 藥學學報, 2015, 50(11): 1380-1387.
24.	孫杰, 陳君超, 劉紅霞, 等. 基于電子化臨床數據采集平臺的中央隨機系統特點及應用. 中國新藥與臨床雜志, 2010, 29(9): 711-715.
25.	陸振宇, 徐秀卉, 徐蓉, 等. ERP+CSV在制藥企業中的實施應用. 中國醫藥工業雜志, 2019, 50(12): 1498-1508.
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1. Fisher RA. The design of experiments. London: Oliver and Boyd, 1960.
2. 陳君超, 何迎春, 陳歡, 等. 隨機化方法與技術在當前臨床試驗中的應用. 中國新藥雜志, 2019, 28(13): 1582-1586.
3. 劉雅琦, 劉曼, 劉玉秀, 等. 《新英格蘭醫學雜志》臨床試驗隨機化方法應用狀況評價. 中國循證醫學雜志, 2021, 21(3): 303-307.
4. 劉紅霞, 孫杰, 李興珊, 等. 基于網絡的隨機化系統在臨床試驗中的應用及其評價. 中國新藥雜志, 2010, 19(8): 657-661.
5. 劉保延, 文天才, 姚晨, 等. 多中心臨床試驗中的中央隨機系統研究. 中國新藥與臨床雜志, 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. 國家食品藥品監督管理總局. 藥物臨床試驗管理規范, 附錄: 計算機化系統, 2015. Available at: https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20150526120001509.html.
11. 國家食品藥品監督管理總局. 藥物臨床試驗管理規范, 附錄: 確認與驗證, 2015. Available at: https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20150526120001509.html.
12. 湯繼亮. GAMP5的基本概念和內容簡介. 醫藥工程設計, 2012, 33(4): 43-50.
13. 樓偉剛. GAMP5解讀與儀器研發應用實踐. 上海: 上海交通大學, 2015.
14. 曾英, 王悅豐. 制藥企業遵循GAMP5的計算機化系統驗證實踐探討. 上海醫藥, 2011, 32(8): 403-405.
15. 朱麗娜. 臨床試驗電子數據采集系統驗證的應用研究. 廣州: 暨南大學, 2017.
16. 沈忱, 陸振宇, 徐秀卉, 等. 基于GAMP5的計算機化系統驗證的實際應用. 中國醫藥工業雜志, 2018, 49(8): 1195-1202.
17. 朱玉潔, 李麗, 周莉莉. 基于GAMP5的藥物臨床試驗計算機化系統驗證的實證研究. 中國衛生產業, 2018, 15(4): 151-153.
18. 路佳特. 計算機化系統驗證方法探討. 中國醫藥工業雜志, 2017, 48(12): 1818-1821.
19. 李科, 閔旸. 風險評估在計算機化系統驗證中的應用. 2017年(第七屆)藥物毒理學年會, 2017.
20. 胡勇. 網絡信息系統風險評估方法研究. 成都: 四川大學, 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. 顏崇超, 陳峰, 夏結來, 等. 臨床試驗中計算機化系統的驗證. 藥學學報, 2015, 50(11): 1380-1387.
24. 孫杰, 陳君超, 劉紅霞, 等. 基于電子化臨床數據采集平臺的中央隨機系統特點及應用. 中國新藥與臨床雜志, 2010, 29(9): 711-715.
25. 陸振宇, 徐秀卉, 徐蓉, 等. ERP+CSV在制藥企業中的實施應用. 中國醫藥工業雜志, 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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