关键词: 远程监查, 临床试验, 数据完整性, 数据安全, 技术挑战, 远程质控

Abstract:

Reducing costs and increasing efficiency is an important topic to improve the return on investment in clinical trial research and development. Remote monitoring improves audit efficiency and reduces operating costs by remotely accessing original records. The use of remote monitoring in clinical trials is changing the traditional clinical trial model. This study analyzes the practice cases of remote monitoring in clinical trials at home and abroad such as Sitelink remote monitoring platform， and discusses the application status， main benefits and challenges of remote monitoring in clinical trials. Although the remote monitoring of clinical trials started late in China， it is developing rapidly and has been successfully implemented in many research centers， showing great potential and value.The study found that remote monitoring can significantly improve data reliability and optimize resource allocation.Although remote monitoring faces challenges such as data integrity and unclear site guidelines， these challenges can be effectively addressed through technical optimization， regulatory and ethical guidance， personnel training， data security and privacy protection， and other measures.The popularization and promotion of the remote monitoring system is expected to achieve the optimal allocation and utilization of resources， improve the overall efficiency and data accuracy of clinical trials， improve the quality of clinical trials， and make greater contributions to global health research.

Key words:  , Remote monitoring； , Clinical trial； , Data integrity； , Data security； , Technical challenges； , Remote quality control