纸质记录是在临床试验活动中记录和产生的、可完整重现和评估相应活动的原始记录，是阐明所取得结果或提供完成试验的证据。尽管电子化文件在临床试验中已经被广泛采用，但是纸质文件仍然是中国临床试验记录的主要方式之一。但是当前我国临床试验纸质记录受控管理并未形成共识，同时不同机构之间的操作也存在较大差异，在一定程度上对临床试验的质量产生不利影响。通过全面梳理国内外纸质记录受控管理相关的法规及实践，同时结合工作实践提出了相应的解决策略，以期推动我国临床试验纸质文件受控管理，全面提升药物临床研究的质量。

Paper records are the original and reproducible documentation recorded and generated during clinical trials, with which elucidates obtained results and provide evidence in trial inspection. Although electronic data has been widely used in clinical trials, paper documents are still one of the main methods of recording clinical trials in China. Currently, there is considerable debate about controlled management of paper records in clinical trials within China. Meanwhile,there are significant differences in the practice of different institutions, which to some extent affects the clinical trial quality. This paper proposed corresponding strategies based on work practice by referring to domestic and foreign regulations and practices related to the controlled management of paper records in order to promote the comprehensive improvement of clinical research quality in this field.

上海市中医药“三年行动计划”资助项目［ZY（2021-2023）-0211］；上海市“科技创新行动计划”生物医药科技支撑专项（20S21902100）；上海市教委协同创新中心中西医结合-中成药临床评价平台（A1-U21-205-0103）；上海市申康中心示范性研究型病房建设（SHDC2022CRW010）；上海市申康中心医企融合创新协同专项（SHDC2022CRT018）；上海市慢性筋骨病临床医学研究中心项目（20MC1920600）；上海市科委2022年度第三批应急科技攻关项目（22YJ1900505）