临床试验数据核查和用户接受测试Clinicaltrialdata-药学学报.PDF

1480 药学学报 Acta Pharmaceutica Sinica 20 15, 50 ( 11): 1480 1484 床试验数据核查和用户接受测试 * 孙华龙, 代 囡 (美达临床数据技术有限公司, 上海 20003 1) 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。 关键词: 临床数据管理; 数据核查; 编辑核查; 离线核查列表; 用户接受测试 中图分类号: R969 文献标识码: A 文章编号: 0513-4870 (20 15) 11-1480-05 Clinical trial data validation and user acceptance testing * SUN Hua-long , DAI Nan (Meta Clinical Technology, Shanghai 200031, China ) 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. Key words: clinical data management; data validation; edit check; offline listing; user acceptance testing 对制药企业而言, 临床试验数据是最有价值的 GCP 要求质量控