Promoting standardization of clinical trial data management in China_Chinese Journal of Evidence-Based Medicine

Authors：

 WU Taixiang ¹ , BIAN Zhaoxiang ² ,  LI Youping ¹ , SHANG Hongcai ³

1. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
2. School of Chinese Medicine, Hong Kong Baptist University, Hongkong, 999077, P.R.China;
3. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China;

Corresponding author：

WU Taixiang, Email: chictr@vip.qq.com; LI Youping, Email: yzmylab@hotmail.com

Keywords：

Clinical trial data; Data management; Standardization

DOI：

10.7507/1672-2531.201804096

Video：

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Abstract Full text Figures/Tables Video References Cited by

Data management system is a major factor affecting the quality of clinical trial. Development of data management system include a steering group and data safety and monitoring board, data collection, database, performance of the data safety and monitoring, as well as locking of database. This article provides key issues of the five parts so as to help researchers understand the clinical trial data management system.

Citation： WU Taixiang, BIAN Zhaoxiang, LI Youping, SHANG Hongcai. Promoting standardization of clinical trial data management in China. Chinese Journal of Evidence-Based Medicine, 2018, 18(6): 532-537. doi: 10.7507/1672-2531.201804096 Copy

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1. 临床数据造假, 政策逼出的潜规则. Available at: http://news.163.com/15/0821/07/B1HCKC0O00014JHT.html.
2. 新药临床试验数据为何造假成风. Available at: http://view.news.qq.com/original/intouchtoday/n3273.html.
3. 八成新药数据涉假曝医药生态恶劣. Available at: http://www.jjckb.cn/2016-09/09/c_135673951.htm.
4. 80% of data in Chinese clinical trials have been fabricated. Available at: http://www.sciencealert.com/80-of-the-data-in-chinese-clinical-trial-is-fabricated.
5. Wu T, Li Y, Bian Z, et al. Randomized trials published in some Chinese journals: how many are randomized? Trials, 2009, 10: 46.
6. Wu XK, Stener-Victorin E, Kuang HY, et al. Effect of acupuncture and clomiphene in Chinese women with polycystic ovary syndrome: a randomized clinical trial. JAMA, 2017, 317(24): 2502-2514.
7. Chen ZJ, Shi Y, Sun Y, et al. Fresh versus frozen embryos for infertility in the polycystic ovary syndrome. N Engl J Med, 2016, 375(6): 523-533.
8. DeMets DL, Ellenberg SS. Data monitoring committees - expect the unexpected. N Engl J Med, 2016, 375(14): 1365-1371.
9. U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), et al. Guidance for industry: part 11, electronic records; electronic signatures - scope and application. Pharmaceutical CGMPs, 2003. Available at: https://www.fda.gov/Regulato-ryInformation/Guidances/ucm125067.htm.
10. U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Office of the Commissioner (OC). Guidance for industry: computerized systems used in clinical investigations, 2007. Available at: https://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm135196.htm.
11. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), et al. Guidance for industry: electronic source data in clinical investigations. September 2013. Available at: https://www.fda.gov/training/guidancewebinars/ucm382198.htm.
12. Society for Clinical Data Management (SCDM). Good clinical data management practices (GCDMP), 2007. Available at: http://www.scdm.org/publications/gcdmp/.
13. CDISC. Introducing the CDISC Standards: New Efficiencies for Medical Research, 2009. Available at: https://www.cdisc.org/.

Chinese Journal of Evidence-Based Medicine

Promoting standardization of clinical trial data management in China

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