【摘要】 真实世界数据(RWD)/真实世界证据(RWE)的应用已成为当前热点话题，临床研究开展过程中受试者个人信息和隐私保护问题同样日渐引起关注。本文基于相关的法规和技术指南，结合RWD的主要来源及特点，讨论在真实世界研究(RWS)开展过程中受试者个人信息和隐私保护的关注要点，以期为更好地应用RWD/RWE及规范RWS中数据治理的关键环节提供有益的参考。更多还原

【Abstract】 The application of real world data(RWD)/real world evidence(RWE) has become a hot topic at present, and the protection of personal information and privacy subjects of clinical trials has also attracted increasing attention. Based on relevant regulations and technical guidelines, combined with the main sources and characteristics of RWD, this article discussed the main concern points for the protection of personal information and privacy of subjects in the process of real world study(RWS) in order to provide useful references for better application of RWD/RWE and standardization of key step in data curation.更多还原