【摘要】：數(shù)據(jù)核查是臨床研究從醫(yī)學(xué)語言轉(zhuǎn)化為統(tǒng)計語言的數(shù)字化、數(shù)據(jù)化和標(biāo)準(zhǔn)化過程,是統(tǒng)計結(jié)論科學(xué)性來源的關(guān)鍵環(huán)節(jié)。文章以黑龍江中醫(yī)臨床研究基地(婦科)承擔(dān)的一項(xiàng)大型不孕癥臨床研究為例,詳細(xì)介紹不孕癥臨床試驗(yàn)數(shù)據(jù)核查的主要內(nèi)容,包括基線、療效與安全性指標(biāo)等數(shù)據(jù)的真實(shí)、完整、準(zhǔn)確、時效性;提出核查重點(diǎn)與難點(diǎn),也是核查策略的核心內(nèi)容在于納排標(biāo)準(zhǔn)、孕產(chǎn)結(jié)局指標(biāo)邏輯關(guān)系、不良事件分人群分階段數(shù)據(jù)與干預(yù)措施依從性數(shù)據(jù)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.
【作者單位】： 黑龍江中醫(yī)藥大學(xué)附屬第一醫(yī)院;
【基金】：2011年國家重大科技專項(xiàng)項(xiàng)目(No.201107005) 世界中醫(yī)藥學(xué)會聯(lián)合會合作項(xiàng)目(No.WFCMS-2016-001)~~
【分類號】：R711.6

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