临床试验全流程智能信息系统研究与实践OA

Objective To develop a clinical trial management system(CTMS)to realize full-process review and management of clinical trial projects,research team management,document management,subject management,drug sample management,free medical order management and quality management.Methods Within the framework of the existing hospital information system,we collaborated with the hospital information center and a commercial software company to design and develop a full-process intelligent information system for clinical trials.Based on WebService,the system was connected to the hospital information system through standardized application programming interfaces(APIs),with the establishment of standard data dictionaries and governance rules to achieve secure data exchange between heterogeneous systems.Results The system balanced development costs and functionality,and achieved good application effects.It integrated functions including project process,document management,drug sample management,subject management,free inspection and testing,and quality management,formed a medical database covering the entire project cycle of subjects,and ensured the authenticity and traceability of data.Conclusion This system fully leverages the advantages of joint development and informatization,improves the enrollment efficiency and implementation quality of clinical trials,and provides reference experience for other hospitals to implement integrated clinical trial management systems.