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本研究以电子化数据管理的中药新药Ⅲ期临床试验为例，通过对该项目数据管理过程和研究数据情况统计描述，分析中药新药临床研究电子化数据管理过程中影响临床研究质量的因素，为规范中医临床研究电子化数据管理过程提出建议。“,”Taking a phase-Ⅲ clinical trial of Traditional Chinese Medi-cine (TCM) investigational new drugs managed by electronic data as an example,this paper analyzed the factors which influenced the quality of clinical trial in the process of the electronic data management,based on the statistical description of data management and clinical research data.It also proposed suggestions for regulating electronic data management of TCM clinical research.