臨床試驗必備文件是確認臨床試驗實施的真實性和所收集數(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數(shù)據(jù)鏈條清晰完整和可溯源的前提?？偨Y了臨床試驗必備文件的特點和提高原始文件書寫質量的方法，結合具體實例探討建立完善必備文件的管理制度與標準，加快推進藥物臨床試驗檔案管理現(xiàn)代化建設、智能化檔案管理，籍以提升藥物臨床試驗整體質量，促進新藥臨床研發(fā)的順利推進。

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.

R965.2

北京市醫(yī)院管理中心“青苗”計劃專項經費資助項目（QMS20200811）；北京市醫(yī)院管理中心“登峰”計劃專項經費資助項目（DFL20190803）；首都科技領軍人才項目（Z191100006119017）