本文選題：臨床數(shù)據(jù)管理　切入點(diǎn)：數(shù)據(jù)核查　出處：《藥學(xué)學(xué)報》2015年11期 　論文類型：期刊論文

【摘要】：對制藥企業(yè)而言,臨床試驗(yàn)數(shù)據(jù)是最有價值的產(chǎn)出之一,是分析、提交、批準(zhǔn)及一個產(chǎn)品的標(biāo)簽和上市的基礎(chǔ)。為了確保臨床數(shù)據(jù)的真實(shí)性和可靠性,必須對整個臨床試驗(yàn)的每個環(huán)節(jié)進(jìn)行科學(xué)而規(guī)范的質(zhì)量控制。數(shù)據(jù)核查就是通過對數(shù)據(jù)質(zhì)量的檢查確保被統(tǒng)計分析前的數(shù)據(jù)的合理性和試驗(yàn)的依從性。本文介紹了數(shù)據(jù)核查的目的、數(shù)據(jù)核查計劃書的撰寫、數(shù)據(jù)核查的原理和類型以及數(shù)據(jù)庫編輯核查或離線核查列表的編程結(jié)束后數(shù)據(jù)庫的用戶接受測試。
[Abstract]:For pharmaceutical companies, clinical trial data is one of the most valuable outputs, the basis for analysis, submission, approval, and labelling and marketing of a product. Scientific and standard quality control must be carried out on every link of the whole clinical trial. Data verification is to ensure the rationality of the data before statistical analysis and the compliance of the test through the examination of the data quality. The purpose of data verification, The writing of the data verification plan, the principle and type of data verification, and the testing of database users after the completion of the programming of the database edit verification or offline verification list.
【作者單位】： 美達(dá)臨床數(shù)據(jù)技術(shù)有限公司;
【分類號】：R95
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本文編號：1576296