[關(guān)鍵詞]
[摘要]
臨床試驗(yàn)必備文件是確認(rèn)臨床試驗(yàn)實(shí)施的真實(shí)性和所收集數(shù)據(jù)完整性的依據(jù)。規(guī)范的檔案管理是保證藥物臨床試驗(yàn)數(shù)據(jù)鏈條清晰完整和可溯源的前提?？偨Y(jié)了臨床試驗(yàn)必備文件的特點(diǎn)和提高原始文件書寫質(zhì)量的方法，結(jié)合具體實(shí)例探討建立完善必備文件的管理制度與標(biāo)準(zhǔn)，加快推進(jìn)藥物臨床試驗(yàn)檔案管理現(xiàn)代化建設(shè)、智能化檔案管理，籍以提升藥物臨床試驗(yàn)整體質(zhì)量，促進(jìn)新藥臨床研發(fā)的順利推進(jìn)。
[Key word]
[Abstract]
The essential documents for clinical trial are the basis for confirming the authenticity of clinical trial implementation process and the integrity of data. Standardized file management is the premise to ensure that the data chain of drug clinical trials is clear, complete, and traceable. This paper summarizes the characteristics of essential documents for clinical trials and the methods to improve the quality of original documents. Combined with specific examples, it discusses the establishment and improvement of management systems and standards for essential documents, and accelerates the modernization of drug clinical trial file management and intelligent file management, which can improve the overall quality of drug clinical trials and promote the smooth progress of new drug clinical research and development.
[中圖分類號(hào)]
R965.2
[基金項(xiàng)目]
北京市醫(yī)院管理中心“青苗”計(jì)劃專項(xiàng)經(jīng)費(fèi)資助項(xiàng)目（QMS20200811）；北京市醫(yī)院管理中心“登峰”計(jì)劃專項(xiàng)經(jīng)費(fèi)資助項(xiàng)目（DFL20190803）；首都科技領(lǐng)軍人才項(xiàng)目（Z191100006119017）
