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中国临床药理学与治疗学 ›› 2004, Vol. 9 ›› Issue (6): 717-720.

• 设计与统计 • 上一篇    

临床试验数据质量的评估

王怡兵, 熊宁宁, 卜擎燕, 邹建东, 蒋萌, 刘芳, 符为民   

  1. 南京中医药大学附属医院国家药品临床研究基地, 南京210029, 江苏
  • 收稿日期:2004-02-01 修回日期:2004-04-06 出版日期:2004-06-26 发布日期:2020-11-22
  • 通讯作者: 熊宁宁, 男, 教授, 主任医师, 博士生导师, 主要从事临床药理研究。Tel:025-86506055  E-mai l:xiongnin @public1.ptt.js.cn
  • 作者简介:王怡兵, 女, 博士研究生。
  • 基金资助:
    科技部“ 临床试验关键技术及平台研究” 项目(No2002AA2Z341i)

Measuring data quality of clinical trials

WANG Yi-Bing, XIONG Ning-Ning, BO Qing-Yan, ZOU Jian-Dong, JIANG Meng, LIU Fang, FU Wei-Min   

  1. National Base for Drug Clinical Trial, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, Jiangsu, China
  • Received:2004-02-01 Revised:2004-04-06 Online:2004-06-26 Published:2020-11-22

摘要: 临床试验数据的采集、报告与处理的每一步骤都可能伴随错误, 临床试验数据质量的评估是临床试验质量控制的重要措施。数据质量评估技术如:数据精度评估技术, 研究者信度评估技术, 汇总统计(Aggregate Statistics)和对试验过程的统计监控图(Statistical Process Control Charts)技术, 数据记录一致性的交叉核对技术, 实验室报告常规格式核对技术, 关联文件与关联数据的核查技术, 源数据与CRF以及CRF 与数据库对照检查技术, 数据库数据证实(Data Validation)技术, 数据处理过程的差错率评估技术, 实验室数据标准化技术(laboratory normalizationtechniques), 数据清理(data clean)技术。

关键词: 质量控制, 数据质量评估, 源文件, 源数据, 数据精度

Abstract: Each step about data which are collected, reported and manipulated has an error rate associated with it.Therefore, measuring data quality is a key element of quality control for clinical trial data.The techniques of measuring data quality includes:evaluating data precision, establishing inter-rater reliability, aggregating statistics and statistical process control charts, cross checking between referential data, checking the format of lab reports, checking among relevant documents and data, comparing between source data and CRF, and between CRF and database, data validating, calculating error rate in the processes of data processing, laboratory normalizing and data cleaning.

Key words: quality control, measuring data quality, source document, source data, data precision

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