【摘要】：源數(shù)據(jù)及其源文件是臨床研究數(shù)據(jù)的重要組成部分。隨著臨床試驗(yàn)技術(shù)的不斷進(jìn)步,臨床試驗(yàn)的源數(shù)據(jù)呈現(xiàn)出電子化的發(fā)展趨勢(shì)。當(dāng)前我國(guó)臨床試驗(yàn)的源數(shù)據(jù)處于紙質(zhì)和電子形式并存的狀態(tài)。本文在明確定義源數(shù)據(jù)及相關(guān)概念的基礎(chǔ)上,列舉了紙質(zhì)源數(shù)據(jù)和電子源數(shù)據(jù)的具體表現(xiàn)形式,并指出電子源數(shù)據(jù)的優(yōu)勢(shì)。同時(shí),還從源數(shù)據(jù)的采集方式、可溯源性、質(zhì)量標(biāo)準(zhǔn)、管理授權(quán)、文件保存、安全性保障等方面對(duì)源數(shù)據(jù)管理提出要求。
[Abstract]:The source data and its source files are an important part of the clinical study data. With the continuous improvement of clinical trial technology, the source data of clinical trial shows the trend of electronic. The current source data of clinical trials in our country is in the state of both paper and electronic form. Based on the definition of the source data and the related concepts, the paper lists the specific forms of the paper source data and the electronic source data, and points out the advantages of the electronic source data. At the same time, the source data collection mode, the traceability, the quality standard, the management authorization, the file storage, the security guarantee and the like are also required for the source data management.
【作者單位】： 中國(guó)臨床試驗(yàn)數(shù)據(jù)管理學(xué)組;
【分類號(hào)】：R95
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本文編號(hào)：2445094