不孕症大型临床试验的数据核查策略
发布时间：2018-11-09 07:35
【摘要】：数据核查是临床研究从医学语言转化为统计语言的数字化、数据化和标准化过程,是统计结论科学性来源的关键环节。文章以黑龙江中医临床研究基地(妇科)承担的一项大型不孕症临床研究为例,详细介绍不孕症临床试验数据核查的主要内容,包括基线、疗效与安全性指标等数据的真实、完整、准确、时效性;提出核查重点与难点,也是核查策略的核心内容在于纳排标准、孕产结局指标逻辑关系、不良事件分人群分阶段数据与干预措施依从性数据的核查。
[Abstract]:Data verification is the process of digitizing, digitizing and standardizing clinical research from medical language to statistical language, and is the key link of scientific source of statistical conclusion. Taking a large clinical study of infertility undertaken by Heilongjiang Clinical Research Base of TCM (Gynecology) as an example, this paper introduces in detail the main contents of the data verification of clinical trial of infertility, including the truth of baseline, curative effect and safety data, etc. Integrity, accuracy, timeliness; The key points and difficulties of verification are also the core contents of verification strategy, such as the criteria of admission, the logical relationship of maternal outcome, the verification of adverse events in different stages of population and the compliance data of intervention measures.
【作者单位】： 黑龙江中医药大学附属第一医院;
【基金】：2011年国家重大科技专项项目(No.201107005) 世界中医药学会联合会合作项目(No.WFCMS-2016-001)~~
【分类号】：R711.6
本文编号：2319766
[Abstract]:Data verification is the process of digitizing, digitizing and standardizing clinical research from medical language to statistical language, and is the key link of scientific source of statistical conclusion. Taking a large clinical study of infertility undertaken by Heilongjiang Clinical Research Base of TCM (Gynecology) as an example, this paper introduces in detail the main contents of the data verification of clinical trial of infertility, including the truth of baseline, curative effect and safety data, etc. Integrity, accuracy, timeliness; The key points and difficulties of verification are also the core contents of verification strategy, such as the criteria of admission, the logical relationship of maternal outcome, the verification of adverse events in different stages of population and the compliance data of intervention measures.
【作者单位】： 黑龙江中医药大学附属第一医院;
【基金】：2011年国家重大科技专项项目(No.201107005) 世界中医药学会联合会合作项目(No.WFCMS-2016-001)~~
【分类号】：R711.6
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