Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (8): 841-846.doi: 10.3736/jcim20120802

Previous Articles     Next Articles

Discussion on developing a data management plan and its key factors in clinical study based on electronic data capture system

Qing-na Li1, Xiu-ling Huang2, Rui Gao1, Fang Lu1()   

  1. 1. GCP Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China
    2. Department of Traditional Chinese Medicine, Tancheng First People’s Hospital, Linyi 276100, Shandong Province, China;
  • Received:2012-02-16 Accepted:2012-04-08 Online:2012-08-20 Published:2018-08-15
  • Contact: Lu Fang E-mail:deerfang@126.com

Data management has significant impact on the quality control of clinical studies. Every clinical study should have a data management plan to provide overall work instructions and ensure that all of these tasks are completed according to the Good Clinical Data Management Practice (GCDMP). Meanwhile, the data management plan (DMP) is an auditable document requested by regulatory inspectors and must be written in a manner that is realistic and of high quality. The significance of DMP, the minimum standards and the best practices provided by GCDMP, the main contents of DMP based on electronic data capture (EDC) and some key factors of DMP influencing the quality of clinical study were elaborated in this paper. Specifically, DMP generally consists of 15 parts, namely, the approval page, the protocol summary, role and training, timelines, database design, creation, maintenance and security, data entry, data validation, quality control and quality assurance, the management of external data, serious adverse event data reconciliation, coding, database lock, data management reports, the communication plan and the abbreviated terms. Among them, the following three parts are regarded as the key factors: designing a standardized database of the clinical study, entering data in time and cleansing data efficiently. In the last part of this article, the authors also analyzed the problems in clinical research of traditional Chinese medicine using the EDC system and put forward some suggestions for improvement.

Key words: clinical trial, data management plan, case management, electronic data capture, management information systems, standard operational procedures

Table 1

Time schedule of data management"

Stage Item
Preparation Data management plan development
Data validation plan development
Database design and user acceptance testing
Programming (referring to data validation
plan) and user acceptance testing
Implementation Data entry
Source data validation
Check and review
Serious adverse event reconciliation
Medical coding completed and approved
Completion Database lock
Data export
Data management report completed and
approved
Documentation archiving
[1] Sun YL, He J, Cao Y . Development of clinical data management system: current status home and abroad[J]. Di Er Jun Yi Da Xue Xue Bao, 2006,27(7):721-725
孙亚林, 贺佳, 曹阳 . 国内外临床数据管理系统发展现状[J]. 第二军医大学学报, 2006,27(7):721-725
[2] Society for Clinical Data Management, Inc. Good clinical data management practices. Version 4.0. (2011-04)[2012-02-14]. . Good clinical data management practices. Version 4.0. (2011-04)[2012-02-14]. .
[3] Yan CC. Data management in clinical research. Beijing: Science Press. 2011. Chinese.
颜崇超 . 医药临床研究中的数据管理. 北京: 科学出版社. 2011.
[4] International Conference on Harmonization . Guideline for Industry E6 Good Clinical Practice: Consolidated Guideline. (1996-04)[2009-07-22]. .
[5] Yu YP, Zhu SN, Yan XY, Yao C . A study of sources and types of queries in drug clinical trials[J]. Zhongguo Xin Yao Za Zhi, 2011,20(11):1004-1011
于永沛, 朱赛楠, 阎小妍, 姚晨 . 新药临床试验数据管理常见疑问类型分析[J]. 中国新药杂志, 2011,20(11):1004-1011
[6] Pu QY, Xiong NN, Zou JD, Jiang M, Liu F, Wang XQ, Gao WM . Electronic data capture:achieving the promise of more efficient and higher quality clinical trials[J]. Zhongguo Lin Chuang Yao Li Xue Yu Zhi Liao Xue, 2007,12(4):455-459
卜擎燕, 熊宁宁, 邹建东, 蒋萌, 刘芳, 汪秀琴, 高维敏 . 电子数据获取: 实现更加优质与高效的临床研究[J]. 中国临床药理学与治疗学, 2007,12(4):455-459
[7] He LY, Liu BY, Liang ZW, Wen TC . Data administration and quality evaluation in clinical research[J]. Zhongguo Xin Yao Yu Lin Chuang Za Zhi, 2005,24(11):916-919
何丽云, 刘保延, 梁志伟, 文天才 . 临床研究中数据管理及其质量评价[J]. 中国新药与临床杂志, 2005,24(11):916-919
[1] Ning Guo, Fei Wu, Mei Wu, Yuan Wang, Qing Lang, Xiao Lin, Yi Feng. Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine . Journal of Integrative Medicine, 2022, 20(3): 204-212.
[2] Rui-jin Qiu, Min Li, Jia-yuan Hu, Jing Chen, Hong-cai Shang. Methods for development of a core outcome set for clinical trials integrating traditional Chinese medicine and Western medicine. Journal of Integrative Medicine, 2021, 19(5): 389-394.
[3] Pratya Phetkate, Tanawan Kummalue, Prasob-orn Rinthong, Somboon Kietinun, Kusuma Sriyakul. Study of the safety of oral Triphala aqueous extract on healthy volunteers. Journal of Integrative Medicine, 2020, 18(1): 35-40.
[4] Arthur Yin Fan, Hui Ouyang, Xinru Qian, Hui Wei, David Dehui Wang, Deguang He, Haihe Tian, Changzhen Gong, Amy Matecki, Sarah Faggert Alemi. Discussions on real-world acupuncture treatments for chronic low-back pain in older adults. Journal of Integrative Medicine, 2019, 17(2): 71-76.
[5] L. Elisabeth Burton, Fares Qeadan, Mark R. Burge. Efficacy of equine-assisted psychotherapy in veterans with posttraumatic stress disorder. Journal of Integrative Medicine, 2019, 17(1): 14-19.
[6] Ubiratan Cardinalli Adler, Ana Carolina Acorinte, Fernando Oliveira Calzavara, Adriano Andréda Silva, Amarilys de Toledo Cesar, Maristela Schiabel Adler, Edson Zangiacomi Martinez, José Carlos Fernandes Galduróz. Double-blind evaluation of homeopathy on cocaine craving: A randomized controlled pilot study. Journal of Integrative Medicine, 2018, 16(3): 178-184.
[7] Shahnaz Karkon Varnosfaderani, Fataneh Hashem-Dabaghian, Gholamreza Amin, Mahbubeh Bozorgi, Ghazaleh Heydarirad, Esmaeil Nazem, Mohsen Nasiri Toosi, Seyed Hamdollah Mosavat. Efficacy and safety of Amla (Phyllanthus emblica L.) in non-erosive reflux disease: A double-blind, randomized, placebo-controlled clinical trial. Journal of Integrative Medicine, 2018, 16(2): 126-131.
[8] Maryam Sharifi-Ardani, Leili Yekefallah, Saeed Asefzadeh, Marjan Nassiri-Asl. Efficacy of topical chamomile on the incidence of phlebitis due to an amiodarone infusion in coronary care patients: A double-blind, randomized controlled trial. Journal of Integrative Medicine, 2017, 15(5): 373-378.
[9] Susana Seca, Sebastian Kirch, António S.Cabrita, Henry J.Greten. Evaluation of the effect of acupuncture on hand pain, functional deficits and health-related quality of life in patients with rheumatoid arthritis—A study protocol for a multicenter, double-blind, randomized clinical trial. Journal of Integrative Medicine, 2016, 14(3): 219-227.
[10] Arthur Yin Fan. The methodology flaws in Hinman’s acupuncture clinical trial, Part III: Sample size calculation. Journal of Integrative Medicine, 2015, 13(4): 209-211.
[11] Arthur Yin Fan. The methodology flaws in Hinman’s acupuncture clinical trial, Part II: Zelen design and effectiveness dilutions. Journal of Integrative Medicine, 2015, 13(3): 136-139.
[12] Arthur Yin Fan. The methodology flaws in Hinman’s acupuncture clinical trial, Part I: Design and results interpretation. Journal of Integrative Medicine, 2015, 13(2): 65-68.
[13] Vamsi Reddy, Arvind Sridhar, Roberto F. Machado, Jiwang Chen. High sodium causes hypertension: Evidence from clinical trials and animal experiments. Journal of Integrative Medicine, 2015, 13(1): 1-8.
[14] Arndt Büssing, Ariane von Bergh, Xiao-feng Zhai, Chang-quan Ling. Interpretation of illness in patients with chronic diseases from Shanghai and their associations with life satisfaction, escape from illness, and ability to reflect the implications of illness. Journal of Integrative Medicine, 2014, 12(5): 409-416.
[15] Subhranil Saha​, Munmun Koley​, Subhasish Ganguly​, Prasanta Rath​, Pulak Roy Chowdhury, Seikh Intaj Hossain. Developing the criteria for evaluating quality of individualization in homeopathic clinical trialreporting: A preliminary study. Journal of Integrative Medicine, 2014, 12(1): 13-19.
Viewed
Full text


Abstract

Cited

  Shared   
  Discussed   
[1] Dong Yang, Yong-ping Du, Qing Shen, Wei Chen, Yan Yu, Guang-lei Chen. Expression of alpha-smooth muscle actin in renal tubulointerstitium in patients with kidney collateral stasis. Journal of Chinese Integrative Medicine, 2008, 6(1): 41-44
[2] Hai-feng Wei, Bai-liu Ya, Ling Zhao, Cui-fei Ye, Li Zhang, Lin Li. Evaluation of tongue manifestation of blood stasis syndrome and its relationship with blood rheological disorder in a rat model of transient brain ischemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 73-76
[3] Xi Lin, Jian-ping Liu. Herbal medicines for viral myocarditis. Journal of Chinese Integrative Medicine, 2008, 6(1): 76
[4] Xi Lin, Jian-ping Liu. Tai chi for treating rheumatoid arthritis. Journal of Chinese Integrative Medicine, 2008, 6(1): 82
[5] Liang-ping Hu, Hui Gao. Discrimination of errors in statistical analysis of medical papers published in the first issue of 2006 in Journal of Chinese Integrative Medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 98-106
[6] Yan-bo Zhu , Qi Wang, Cheng-yu Wu, Guo-ming Pang, Jian-xiong Zhao, Shi-lin Shen, Zhong-yuan Xia , Xue Yan . Logistic regression analysis on relationships between traditional Chinese medicine constitutional types and overweight or obesity. Journal of Chinese Integrative Medicine, 2010, 8(11): 1023-1035
[7] Wei Xu, Meng Shi, Jian-gang Liu, Cheng-long Wang . Collagen protein expressions in ischemic myocardium of rats with acute myocardial infarction and effects of qi-tonifying, yin-tonifying and blood-activating herbs and detoxifying and blood-activating herbs. Journal of Chinese Integrative Medicine, 2010, 8(11): 1041-1047
[8] Tao Wang , Feng Qin. Effects of Chinese herbal medicine Xiaoyao Powder on monoamine neurotransmitters in hippocampus of rats with postpartum depression. Journal of Chinese Integrative Medicine, 2010, 8(11): 1075-1079
[9] Ying Xu , Chang-chun Zeng , Xiu-yu Cai , Rong-ping Guo , Guang Nie , Ying Jin. Chromaticity and optical spectrum colorimetry of the tongue color in different syndromes of primary hepatic carcinoma. Journal of Chinese Integrative Medicine, 2012, 10(11): 1263-1271
[10] Xiang-ying Mao , Qin Bian , Zi-yin Shen. Analysis of the osteogenetic effects exerted on mesenchymal stem cell strain C3H10T1/2 by icariin via MAPK signaling pathway in vitro. Journal of Chinese Integrative Medicine, 2012, 10(11): 1272-1278