Design and Implementation of A Outpatient Drug Clinical Trial Subject Diagnosis and Treatment Module
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.
Clinical trial of drugsHospital information systemSubject diagnosis and treatment moduleHospital information construction