Strengthening clinical research source data management in hospitals to promote data quality of clinical research in China_Chinese Journal of Evidence-Based Medicine

Authors：

DONG Chongya ¹ ,  YAO Chen ^1,2 , GAO Song ³ , YAN Xiaoyan ² , JIN Feifei ¹ , ZHU Sainan ¹

1. Department of Biostatistics, Peking University First Hospital, Beijing, 100034, P.R.China;
2. Peking University Clinical Research Institute, Beijing, 100191, P.R.China;
3. Center of Information Management, Peking University First Hospital, Beijing, 100034, P.R.China;

Corresponding author：

YAO Chen, Email: yaochen@hsc.pku.edu.cn

Keywords：

Clinical research; Source data; Data quality; Transparency; Electronic medical record; Electronic health record

DOI：

10.7507/1672-2531.201908047

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Data integrity, accuracy, and traceability are key elements of high-quality clinical research, as well as weak links in the promotion of clinical research transparency. How to promote data quality has become a major concern to all clinical research stakeholders. In this article, we dissected and analyzed data generation and capturing process in clinical research, and identified a key aspect in improving data quality: to promote electronic source data, especially to break the barrier between electronic health records and clinical research systems. Additionally, we summarized the experiences regarding this issue in China and overseas to propose a solution suitable for China to improve data quality in clinical research: to strengthen clinical research source data management by building clinical research source data platform and adopt common source data management process in hospitals.

Citation： DONG Chongya, YAO Chen, GAO Song, YAN Xiaoyan, JIN Feifei, ZHU Sainan. Strengthening clinical research source data management in hospitals to promote data quality of clinical research in China. Chinese Journal of Evidence-Based Medicine, 2019, 19(11): 1255-1261. doi: 10.7507/1672-2531.201908047 Copy

1.	National Institutes of Health. NIH clinical research trials and you. Available at: https://www.nih.gov/health-information/nih-clinical-research-trials-you.
2.	董冲亚, 杨莉, 韩鸿宾, 等. 深化临床研究透明化理念加强对研究全过程的监督及管理. 中华医学科研管理杂志, 2019, 32(2): 146-150.
3.	Woodhead M. 80% of China's clinical trial data are fraudulent, investigation finds. BMJ, 2016, 355: i5396.
4.	胡金富, 史玉民. 国外学术期刊同行评审造假的分析及启示-基于 2015 年三次大撤稿事件的分析. 中国科学基金, 2016, (6): 568-571.
5.	U.S. Food and drug administration guidance for industry-electronic source data in clinical investigations. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-source-data-clinical-investigations.
6.	Society for Clinical Data Management The Good Clinical Data Management Practices (GCDMP). Available at: https://scdm.org/publications/gcdmp/.
7.	The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Efficacy Guidelines (E8)-General Considerations for Clinical Trials (R1). Available at: https://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html.
8.	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.
9.	孙鑫, 谭婧, 唐立, 等. 重新认识真实世界研究. 中国循证医学杂志, 2017, 17(2): 126-130.
10.	U.S. Food and Drug Administration Guidance for Industry - Computerized Systems Used in Clinical Investigations. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computerized-systems-used-clinical-investigations.
11.	国家食品药品监管总局. 临床试验数据管理工作技术指南. Available at: http://samr.cfda.gov.cn/WS01/CL0087/160961.html.
12.	The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Efficacy Guidelines (E6)-Guideline for Good Clinical Practice (R2).Available at: https://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html.
13.	Society for Clinical Data Management. eSource implementation in clinical research: a data management perspective. Available at: https://www.scdm.org/publications/white-papers/#.
14.	Nosek BA, Alter G, Banks GC, et al. Scientific standards. Promoting an open research culture. Science, 2015, 348(6242): 1422-1425.
15.	Altman DG, Moher D. Declaration of transparency for each research article. BMJ, 2013, 347: f4796.
16.	Health Canada. Elements of real world data/evidence quality throughout the prescription drug product life cycle. Available at: https://www.canada.ca/en/services/health/publications/drugs-health-products/real-world-data-evidence-drug-lifecycle-report.html.
17.	国家药品监督管理局药品审评中心. 真实世界证据支持药物研发的基本考虑(征求意见稿)中文版. Available at: http://www.cde.org.cn/news.do?method=viewInfoCommon&id=314865.
18.	Yan X, Dong C, Yao C. Protecting the accuracy of clinical trial data in China. Available at: https://blogs.bmj.com/bmj/2018/06/07/protecting-the-accuracy-of-clinical-trial-data-in-china/.
19.	The Office of the National Coordinator for Health Information Technology (ONC). About The ONC Health IT Certification Program. Available at: https://www.healthit.gov/topic/certification-ehrs/about-onc-health-it-certification-program.
20.	U.S. Food and Drug Administration Guidance for Industry-Use of Electronic Health Record Data in Clinical Investigations. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-health-record-data-clinical-investigations-guidance-industry.
21.	De Moor G, Sundgren M, Kalra D, et al. Using electronic health records for clinical research: the case of the EHR4CR project. J Biomed Inform, 2015, 53: 162-173.
22.	The European Institute for Innovation through Health Data (i-HD). From Electronic Health Records to Electronic Data Capture systems. Available at: https://www.i-hd.eu/index.cfm/services/research/ehr2edc/.
23.	王强, 易应萍. 临床医疗大数据治理和应用. 医学信息学杂志, 2018, 39(8): 1-6.
24.	国务院办公厅关于促进和规范健康医疗大数据应用发展的指导意见. Available at: http://www.gov.cn/zhengce/content/2016-06/24/content_5085091.htm.

1. National Institutes of Health. NIH clinical research trials and you. Available at: https://www.nih.gov/health-information/nih-clinical-research-trials-you.
2. 董冲亚, 杨莉, 韩鸿宾, 等. 深化临床研究透明化理念加强对研究全过程的监督及管理. 中华医学科研管理杂志, 2019, 32(2): 146-150.
3. Woodhead M. 80% of China's clinical trial data are fraudulent, investigation finds. BMJ, 2016, 355: i5396.
4. 胡金富, 史玉民. 国外学术期刊同行评审造假的分析及启示-基于 2015 年三次大撤稿事件的分析. 中国科学基金, 2016, (6): 568-571.
5. U.S. Food and drug administration guidance for industry-electronic source data in clinical investigations. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-source-data-clinical-investigations.
6. Society for Clinical Data Management The Good Clinical Data Management Practices (GCDMP). Available at: https://scdm.org/publications/gcdmp/.
7. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Efficacy Guidelines (E8)-General Considerations for Clinical Trials (R1). Available at: https://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html.
8. 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.
9. 孙鑫, 谭婧, 唐立, 等. 重新认识真实世界研究. 中国循证医学杂志, 2017, 17(2): 126-130.
10. U.S. Food and Drug Administration Guidance for Industry - Computerized Systems Used in Clinical Investigations. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computerized-systems-used-clinical-investigations.
11. 国家食品药品监管总局. 临床试验数据管理工作技术指南. Available at: http://samr.cfda.gov.cn/WS01/CL0087/160961.html.
12. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Efficacy Guidelines (E6)-Guideline for Good Clinical Practice (R2).Available at: https://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html.
13. Society for Clinical Data Management. eSource implementation in clinical research: a data management perspective. Available at: https://www.scdm.org/publications/white-papers/#.
14. Nosek BA, Alter G, Banks GC, et al. Scientific standards. Promoting an open research culture. Science, 2015, 348(6242): 1422-1425.
15. Altman DG, Moher D. Declaration of transparency for each research article. BMJ, 2013, 347: f4796.
16. Health Canada. Elements of real world data/evidence quality throughout the prescription drug product life cycle. Available at: https://www.canada.ca/en/services/health/publications/drugs-health-products/real-world-data-evidence-drug-lifecycle-report.html.
17. 国家药品监督管理局药品审评中心. 真实世界证据支持药物研发的基本考虑(征求意见稿)中文版. Available at: http://www.cde.org.cn/news.do?method=viewInfoCommon&id=314865.
18. Yan X, Dong C, Yao C. Protecting the accuracy of clinical trial data in China. Available at: https://blogs.bmj.com/bmj/2018/06/07/protecting-the-accuracy-of-clinical-trial-data-in-china/.
19. The Office of the National Coordinator for Health Information Technology (ONC). About The ONC Health IT Certification Program. Available at: https://www.healthit.gov/topic/certification-ehrs/about-onc-health-it-certification-program.
20. U.S. Food and Drug Administration Guidance for Industry-Use of Electronic Health Record Data in Clinical Investigations. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-health-record-data-clinical-investigations-guidance-industry.
21. De Moor G, Sundgren M, Kalra D, et al. Using electronic health records for clinical research: the case of the EHR4CR project. J Biomed Inform, 2015, 53: 162-173.
22. The European Institute for Innovation through Health Data (i-HD). From Electronic Health Records to Electronic Data Capture systems. Available at: https://www.i-hd.eu/index.cfm/services/research/ehr2edc/.
23. 王强, 易应萍. 临床医疗大数据治理和应用. 医学信息学杂志, 2018, 39(8): 1-6.
24. 国务院办公厅关于促进和规范健康医疗大数据应用发展的指导意见. Available at: http://www.gov.cn/zhengce/content/2016-06/24/content_5085091.htm.

Next Article
Exploration of classical deep learning algorithm in intelligent classification of Chinese randomized controlled trials

Chinese Journal of Evidence-Based Medicine

Strengthening clinical research source data management in hospitals to promote data quality of clinical research in China

Abstract Full text Figures/Tables Video References Cited by

Next Article

Format

Content