关键词: 临床试验, 质量管理, 信息系统, 风险控制, 药物临床试验质量管理规范

Abstract:

Quality management should be implemented throughout the whole process of clinical trials. The use of electronic information systems to manage clinical trials in the hospital has become a general trend. The efficient and high-quality dynamic process management requires continuous improvement and iteration. According to the requirements of Good Clinical Practice （GCP）， all the parties involved in clinical trials should "identify risks affecting key aspects and data of clinical trials”. This study analyzes the common problems in the approval process， researcher authorization， enrollment implementation management， data access information security， and safety information reporting in the clinical trial management from the perspective of medical institutions. By adopting the integration of clinical trial management system （CTMS） and hospital information management system （HIS）， data exchange is achieved， and information systems are used to strengthen permission management， data security， optimize administrative processes， and emphasis safety report management， so as to effectively improve management efficiency， reduce risks and errors， improve the overall quality of clinical trials， and provide a reference example for other hospitals to design or update their clinical trial management system.

Key words: Clinical trial； , Quality management； , Information system； , Risk control； , GCP