门诊药物临床试验受试者诊疗模块的设计与实现

Design and Implementation of A Outpatient Drug Clinical Trial Subject Diagnosis and Treatment Module

目的解决医院药物临床试验项目信息孤岛问题,为医院药物临床试验受试者诊疗模块的信息化建设提供参考。方法以医院信息系统(HIS)为基础,开发并实施药物临床试验项目受试者招募及诊疗模块,将以患者为受试者的临床研究医疗记录信息纳入医院电子病历及HIS系统中。结果该院基于HIS建立了受试者诊疗模块,于2023年3月上线,试用2个月时间内完成3个药物临床试验项目的试点工作;通过建立和运营管理系统(HRP)的数据接口,实现了试验费用从计费卡记账,受试者不用再垫付医疗费用;通过建立和CTMS的数据接口,实现了药物临床试验项目的全流程管理,保证了电子数据的完整性。结论基于HIS的受试者诊疗模块简化了受试者就诊流程,操作便捷,规范了临床试验的项目管理流程,提升了工作效率,实现临床试验项目在医院的高效实施。

Objective Provide reference for the information construction of the patient diagnosis and treatment module in hospital drug clinical trials.Methods Based on hospital information system(HIS),develop and implement the subject recruitment and diagnosis and treatment module of drug clinical trial project,and incorporated the medical record information of clinical research with patients as subjects into the hospital electronic medical record and HIS system.Results Based on HIS,our hospital has established a subject diagnosis and treatment module.Since its launch in March 2023,three pilot drug clinical trial projects have been completed in trial period of 2 months;By establishing a data interface with the Operations Management System(HRP),experimental expenses are recorded from the billing card,and subjects no longer has to pay medical expenses in advance;Through the establishment of data interface with CTMS,the whole process management of drug clinical trial project is realized,and the integrity of electronic data is ensured.Conclusion The subject diagnosis and treatment module based on HIS simplifies the patient treatment process,facilitates operation,standardizes the project management process of clinical trials,improves work efficiency,and achieves efficient implementation of clinical trial projects in hospitals.