孙华龙, 代囡. 临床试验数据核查和用户接受测试J. 药学学报, 2015,50(11): 1480-1484.
引用本文: 孙华龙, 代囡. 临床试验数据核查和用户接受测试J. 药学学报, 2015,50(11): 1480-1484.
SUN Hua-long, DAI Nan. Clinical trial data validation and user acceptance testingJ. Acta Pharmaceutica Sinica, 2015,50(11): 1480-1484.
Citation: SUN Hua-long, DAI Nan. Clinical trial data validation and user acceptance testingJ. Acta Pharmaceutica Sinica, 2015,50(11): 1480-1484.

临床试验数据核查和用户接受测试

Clinical trial data validation and user acceptance testing

  • 摘要: 对制药企业而言, 临床试验数据是最有价值的产出之一, 是分析、提交、批准及一个产品的标签和上市的基础。为了确保临床数据的真实性和可靠性, 必须对整个临床试验的每个环节进行科学而规范的质量控制。数据核查就是通过对数据质量的检查确保被统计分析前的数据的合理性和试验的依从性。本文介绍了数据核查的目的、数据核查计划书的撰写、数据核查的原理和类型以及数据库编辑核查或离线核查列表的编程结束后数据库的用户接受测试。

     

    Abstract: For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.

     

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