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

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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
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