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
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Copyright © the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
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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/.
