临床试验必备文件是确认临床试验实施的真实性和所收集数据完整性的依据。规范的档案管理是保证药物临床试验数据链条清晰完整和可溯源的前提。总结了临床试验必备文件的特点和提高原始文件书写质量的方法，结合具体实例探讨建立完善必备文件的管理制度与标准，加快推进药物临床试验档案管理现代化建设、智能化档案管理，籍以提升药物临床试验整体质量，促进新药临床研发的顺利推进。

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

北京市医院管理中心“青苗”计划专项经费资助项目（QMS20200811）；北京市医院管理中心“登峰”计划专项经费资助项目（DFL20190803）；首都科技领军人才项目（Z191100006119017）