随着我国Ⅰ期临床试验和生物等效性试验（BE试验）的快速发展，以健康受试者/参与者为对象的临床研究规模持续扩大，其管理面临风险评估不足、流程不规范、沟通不充分等多重挑战，直接关系到受试者安全和试验数据质量。为更好地构建Ⅰ期/BE临床试验生态，规范和加强健康受试者/参与者的管理 ，保护健康受试者/参与者权益和安全 ，保证临床试验数据科学、真实、可靠，广东省药学会组织专家，在综合分析实践经验的基础上，制定《Ⅰ期/BE临床试验健康受试者/参与者管理专家共识》。针对健康受试者/参与者的群体特征，围绕Ⅰ期/BE临床试验中健康受试者/参与者的招募管理、查重与病史查询、沟通与宣教、Ⅰ期病房日常管理、隐私与信息保护等全流程提出具体实施建议，强调健康受试者/参与者是临床试验的重要贡献者，应积极推动受试者查重系统的互联互通，探索人工智能、电子化监测等技术在受试者管理中的应用，持续优化“以受试者/参与者为中心”的管理模式。本共识的发布，旨在为Ⅰ期/BE临床试验的实施和健康受试者/参与者的规范化管理提供参考，为我国创新药临床研究的高质量发展提供支撑。

 With the rapid development of Phase I clinical trials and bioequivalence trials （BE trials） in China， the scale of clinical research targeting healthy subjects/participants continues to expand. However， its management faces multiple challenges such as insufficient risk assessment， non-standardized processes， and inadequate communication， which directly impact subject safety and the quality of trial data. To better construct the Phase I/BE clinical trial ecosystem， standardize and strengthen the management of healthy subjects/participants， protect their rights and safety， and ensure that clinical trial data is scientific， authentic， and reliable， the Guangdong Pharmaceutical Association organized experts to develop the "Expert Consensus on the Management of Healthy Subjects/Participants in Phase I/BE Clinical Trials" based on a comprehensive analysis of practical experience. Addressing the group characteristics of healthy subjects/participants， specific implementation suggestions are proposed throughout the entire process of recruitment management， duplicate checking and medical history inquiry， communication and education， daily management of Phase I wards， privacy and information protection for healthy subjects/participants in Phase I/BE clinical trials. It emphasizes that healthy subjects/participants are important contributors to clinical trials， and efforts should be made to actively promote the interconnection and interoperability of subject duplicate checking systems， explore the application of artificial intelligence， electronic monitoring， and other technologies in subject management， and continuously optimize the "subject/participant-centered" management model. This consensus aims to provide reference for the implementation of Phase I/BE clinical trials and the standardized management of healthy subjects/participants， supporting the high-quality development of clinical research for innovative drugs in China.