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

Journal of Chinese Integrative Medicine

Volumn 10, Issue 8, 2012, Pages 841-846

  Li, Qing na ^a   Huang, Xiu ling ^b   Gao, Rui ^a   Lu, Fang ^a  

^a XIYUAN HOSPITAL   (China)

^b Department of Traditional Chinese Medicine   (China)

Author keywords

Case management; Clinical trial; Data management plan; Electronic data capture; Management information systems; Standard operational procedures

Indexed keywords

ARTICLE; CHINESE MEDICINE; CLINICAL PROTOCOL; CLINICAL RESEARCH; CODING; DATA BASE; DATA MANAGEMENT PLAN; ELECTRONIC DATA CAPTURE; HUMAN; INFORMATION PROCESSING; QUALITY CONTROL; STANDARD; VALIDATION PROCESS;

DATA COLLECTION; MEDICAL INFORMATICS; MEDICINE, CHINESE TRADITIONAL;

EID: 84865378010     PISSN: 16721977     EISSN: None     Source Type: Journal    
DOI: 10.3736/jcim2012.802     Document Type: Article

References (7)

1. Sun YL, He J, Cao Y. Development of clinical data management system: current status home and abroad. Di Er Jun Yi Da Xue Xue Bao. 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]. http://www.scdm.org/publications/.
3. Yan CC. Data management in clinical research. Beijing: Science Press. 2011.
4. International Conference on Harmonization. Guideline for Industry E6 Good Clinical Practice: Consolidated Guideline. (1996-04) [2009-07-22]. http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html.
5. Yu YP, Zhu SN, Yan XY, Yao C. A study of sources and types of queries in drug clinical trials. Zhongguo Xin Yao Za Zhi. 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. Zhongguo Lin Chuang Yao Li Xue Yu Zhi Liao Xue. 2007; 12(4): 455-459.
7. He LY, Liu BY, Liang ZW, Wen TC. Data administration and quality evaluation in clinical research. Zhongguo Xin Yao Yu Lin Chuang Za Zhi. 2005; 24 (11): 916-919.