The selection of data governance model of clinical study based on real-world data_Chinese Journal of Evidence-Based Medicine

Authors：

 LI Xueying ¹ , SHA Ruoqi ² ,  YAO Chen ^1,3 , JIN Feifei ¹ , WANG Xicheng ⁴ , YAN Xiaoyan ³ , ZHU Sainan ¹ , SHANG Meixia ¹

1. Department of Biostatistics, Peking University First Hospital, Beijing 100034, P.R.China;
2. Data Governance Center, Baoshang Bank, Beijing 100101, P.R.China;
3. Peking University Clinical Research Institute, Beijing 100191, P.R.China;
4. Beijing Dublin International Collage, Beijing University of Technology, Beijing 100124, P.R.China;

Corresponding author：

LI Xueying, Email: xyinglee@163.com; YAO Chen, Email: yaochen@hsc.pku.edu.cn

Keywords：

Data governance; Clinical study; Real-world data; Source data

DOI：

10.7507/1672-2531.202003122

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Objectives To establish an appropriate data governance mode in according with the database status of clinical study.Methods Forty-six doctors of different seniority with clinical research experience from six hospitals in Beijing were selected by stratified purposeful sampling and semi-structured interview and were used to understand the status and shortcomings of data acquisition and storage in clinical research. The data resource of current clinical studies were summarized and the main target of data governance and the characteristics of clinical study data were explored to establish the domains of clinical study data governance to construct the framework of clinical research data governance.Results Currently, the data sources of clinical studies were diverse, including real-world data from various medical and health records, data collected independently for clinical studies and numerous other sources. However, since collecting the data from electronic medical records was difficult for numerous reasons, a large number of researchers still collected research data by hand writing and stored it insecurely. In addition, the combination of electronic information from multiple sources was difficult. Building ALCOA+CCEA standard clinical research data management system based on clinical research data governance was urgent. Data governance includes data architecture, data model, data standards, data quality, master data, timeliness management, metadata and data security, while life cycle management and data insight were not essential parts.Conclusions Based on the real-world data resources, domains of data governance in clinical study should include data architecture, data model, data standards, data quality, master data, timeliness management, metadata and data security.

Citation： LI Xueying, SHA Ruoqi, YAO Chen, JIN Feifei, WANG Xicheng, YAN Xiaoyan, ZHU Sainan, SHANG Meixia. The selection of data governance model of clinical study based on real-world data. Chinese Journal of Evidence-Based Medicine, 2020, 20(10): 1150-1156. doi: 10.7507/1672-2531.202003122 Copy

1.	董冲亚, 阎小妍, 姚亮, 等. 规范多中心临床试验势在必行. 中国循证医学杂志, 2018, 18(7): 654-656.
2.	孙鑫, 谭婧, 王雯, 等. 真实世界证据助推药械评价与监管决策. 中国循证医学杂志, 2019, 19(5): 521-526.
3.	黄亚芳, 阎小妍, 李雪迎, 等. 真实世界证据在医疗器械临床研究中的应用. 中国循证医学杂志, 2017, 17(12): 1373-1377.
4.	孙鑫, 谭婧, 唐立, 等. 基于真实世界证据的上市后药品评价技术框架体系: 思考与建议. 中国循证医学杂志, 2018, 18(4): 277-283.
5.	中华人民共和国国家质量监督检验检疫总局, 中国国家标准化管理委员会. 数据管理能力成熟度评估模型. Available from: http://openstd.samr.gov.cn/bzgk/gb/newGbInfo?hcno=B282A7BD34CAA6E2D742E0CAB7587DBC.
6.	吴泰相, 卞兆祥, 李幼平, 等. 促进我国临床试验数据管理规范化. 中国循证医学杂志, 2018, 18(6): 532-537.
7.	孙鑫, 谭婧, 王雯, 等. 建立真实世界数据与研究技术规范, 促进中国真实世界证据的产生与使用. 中国循证医学杂志, 2019, 19(7): 755-762.
8.	U.S. Food and Drug Administration. Guidance for industry computerized systems used in clinical investigations. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computerized-systems-used-clinical-investigations.
9.	国家药品监督管理局. 临床试验数据管理工作技术指南. Available from: http://www.nmpa.gov.cn/WS04/CL2138/300192.html.
10.	U.S. Food and Drug Administration. Electronic source data in clinical investigations. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-source-data-clinical-investigations.
11.	The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice (R2). Available from: https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf.
12.	Abraham R, Schneider J, Brocke J. Data governance: a conceptual framework, structured review, and research agenda. Int J Inf Manage, 2019, 49: 424-438.
13.	国家市场监督管理总局, 中国国家标准化管理委员会. 信息技术服务治理第 5 部分: 数据治理规范. Available from: http://openstd.samr.gov.cn/bzgk/gb/newGbInfo?hcno=F3B2108863A2292F5AF0FA645CEE047F.
14.	International Organization for Standardization. Information technology-governance of IT-governance of data-part 1: application of ISO/IEC 38500 to the governance of data ISO/IEC 38505-1: 2017. Available from: https://www.iso.org/standard/56639.html.
15.	The Global Data Management Community. Guide to the data management body of knowledge (DAMA-DMBOK) 2009 functional framework v.3. Available from: https://damadach.org/dama-dmbok-functional-framework/.
16.	胡建平. 医院数据治理框架、技术和实现. 北京: 人民卫生出版社, 2019.
17.	Wang CS, Lin SL, Chou TH, et a1. An integrated data analytics process to optimize data governance of nonprofit organization. Comput Hum Behav, 2019, 101(12): 495-505.
18.	安小米, 王丽丽. 大数据治理体系构建方法框架研究. 图书情报工作, 2019, 63(24): 43-51.
19.	Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence - what is it and what can it tell us? N Engl J Med, 2016, 375(23): 2293-2297.
20.	彭晓霞, 舒啸尘, 谭婧, 等. 基于真实世界数据评价治疗解决的观察性研究设计技术规范. 中国循证医学杂志, 2019, 19(7): 779-786.
21.	高培, 王杨, 罗剑锋, 等. 基于真实世界数据评价治疗结局研究的统计分析技术规范. 中国循证医学杂志, 2019, 19(7): 787-793.
22.	聂晓璐, 武泽昊, 赵厚宇, 等. 使用常规收集医疗卫生数据开展观察性研究的报告规范(药物流行病学版)RECORD-PE 规范中文版(上). 药物流行病学杂志, 2019, 28(3): 190-198, 212.
23.	董冲亚, 姚晨, 高嵩, 等. 加强医院临床研究源数据管理, 提高我国临床研究数据质量. 中国循证医学杂志, 2019, 19(11): 1255-1261.
24.	曹敏, 张来运, 王鹤, 等. 直肠癌 CT 结构式报告的临床应用研究. 放射学实践, 2016, 31(12): 1146-1150.
25.	卢淑祺, 窦志成, 文继荣. 手术病例中结构化数据抽取研究. 计算机学报, 2019, 42(12): 2754-2768.

1. 董冲亚, 阎小妍, 姚亮, 等. 规范多中心临床试验势在必行. 中国循证医学杂志, 2018, 18(7): 654-656.
2. 孙鑫, 谭婧, 王雯, 等. 真实世界证据助推药械评价与监管决策. 中国循证医学杂志, 2019, 19(5): 521-526.
3. 黄亚芳, 阎小妍, 李雪迎, 等. 真实世界证据在医疗器械临床研究中的应用. 中国循证医学杂志, 2017, 17(12): 1373-1377.
4. 孙鑫, 谭婧, 唐立, 等. 基于真实世界证据的上市后药品评价技术框架体系: 思考与建议. 中国循证医学杂志, 2018, 18(4): 277-283.
5. 中华人民共和国国家质量监督检验检疫总局, 中国国家标准化管理委员会. 数据管理能力成熟度评估模型. Available from: http://openstd.samr.gov.cn/bzgk/gb/newGbInfo?hcno=B282A7BD34CAA6E2D742E0CAB7587DBC.
6. 吴泰相, 卞兆祥, 李幼平, 等. 促进我国临床试验数据管理规范化. 中国循证医学杂志, 2018, 18(6): 532-537.
7. 孙鑫, 谭婧, 王雯, 等. 建立真实世界数据与研究技术规范, 促进中国真实世界证据的产生与使用. 中国循证医学杂志, 2019, 19(7): 755-762.
8. U.S. Food and Drug Administration. Guidance for industry computerized systems used in clinical investigations. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computerized-systems-used-clinical-investigations.
9. 国家药品监督管理局. 临床试验数据管理工作技术指南. Available from: http://www.nmpa.gov.cn/WS04/CL2138/300192.html.
10. U.S. Food and Drug Administration. Electronic source data in clinical investigations. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-source-data-clinical-investigations.
11. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice (R2). Available from: https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf.
12. Abraham R, Schneider J, Brocke J. Data governance: a conceptual framework, structured review, and research agenda. Int J Inf Manage, 2019, 49: 424-438.
13. 国家市场监督管理总局, 中国国家标准化管理委员会. 信息技术服务治理第 5 部分: 数据治理规范. Available from: http://openstd.samr.gov.cn/bzgk/gb/newGbInfo?hcno=F3B2108863A2292F5AF0FA645CEE047F.
14. International Organization for Standardization. Information technology-governance of IT-governance of data-part 1: application of ISO/IEC 38500 to the governance of data ISO/IEC 38505-1: 2017. Available from: https://www.iso.org/standard/56639.html.
15. The Global Data Management Community. Guide to the data management body of knowledge (DAMA-DMBOK) 2009 functional framework v.3. Available from: https://damadach.org/dama-dmbok-functional-framework/.
16. 胡建平. 医院数据治理框架、技术和实现. 北京: 人民卫生出版社, 2019.
17. Wang CS, Lin SL, Chou TH, et a1. An integrated data analytics process to optimize data governance of nonprofit organization. Comput Hum Behav, 2019, 101(12): 495-505.
18. 安小米, 王丽丽. 大数据治理体系构建方法框架研究. 图书情报工作, 2019, 63(24): 43-51.
19. Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence - what is it and what can it tell us? N Engl J Med, 2016, 375(23): 2293-2297.
20. 彭晓霞, 舒啸尘, 谭婧, 等. 基于真实世界数据评价治疗解决的观察性研究设计技术规范. 中国循证医学杂志, 2019, 19(7): 779-786.
21. 高培, 王杨, 罗剑锋, 等. 基于真实世界数据评价治疗结局研究的统计分析技术规范. 中国循证医学杂志, 2019, 19(7): 787-793.
22. 聂晓璐, 武泽昊, 赵厚宇, 等. 使用常规收集医疗卫生数据开展观察性研究的报告规范(药物流行病学版)RECORD-PE 规范中文版(上). 药物流行病学杂志, 2019, 28(3): 190-198, 212.
23. 董冲亚, 姚晨, 高嵩, 等. 加强医院临床研究源数据管理, 提高我国临床研究数据质量. 中国循证医学杂志, 2019, 19(11): 1255-1261.
24. 曹敏, 张来运, 王鹤, 等. 直肠癌 CT 结构式报告的临床应用研究. 放射学实践, 2016, 31(12): 1146-1150.
25. 卢淑祺, 窦志成, 文继荣. 手术病例中结构化数据抽取研究. 计算机学报, 2019, 42(12): 2754-2768.

Chinese Journal of Evidence-Based Medicine

The selection of data governance model of clinical study based on real-world data

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