Research And Design Of Intelligent Management Of Integrated Clinical Trial System

At present,when the hospital carries out the drug clinical trial,it is implemented by many departments and projects at the same time,which leads to the participation of many people,and the test cycle is long.Therefore,there are some problems,such as lack of effective control of the use of experimental drugs,inconsistent quality control standards,and traceability of diagnosis and treatment information.The hospital has information system,if the existing clinical trial business processes are analyzed,and make some modifications adapted to the existing system,it is hopeful to solve some of the above problems.The objective of this thesis is to make some improvements in the management of clinical trials in a third-class A hospital,design a main core module of clinical trial management system(CTMS),and set up automatic reminder function for the main nodes in the process of drug trial management based on time series.At the same time,the interface design between other hospital business systems is studied to realize data exchange with hospital information system,clinical information system and data platform.The main contents of this thesis include the following aspects:(1)Through interviews,questionnaires and seminars,we communicate and negotiate with many departments,and adopt the four-stage model to reform and optimize the existing clinical trial management process.(2)Aiming at the problem that the information of the subjects can not be monitored in the whole process,this thesis designs a whole process function management module of the subjects.The closed-loop management method is used to integrate the information of the subjects,and the automatic reminder function of the status of the subjects is realized by setting threshold.(3)In view of the lack of standardized process and lag of quality control in test quality control,a unified quality control standard form is designed,quality control standards are unified,and traceable quality control standardization management module is established.(4)Aiming at the problem of lack of effective control and unsafe safety in the use of experimental drugs,the refined management method is adopted to refine the drug management into several main links,and the threshold value is set to automatically remind the expiry date,so as to realize the refined management function of drugs.(5)In order to share data among heterogeneous systems and achieve the goal of traceability of test data,data interface is designed with interconnection standard to realize the docking between the system and other hospital business systems.Interfaces include view-based interface to hospital information system,storage-based interface to clinical information system,and Oracle Golden Gate(OGG)based interface to data center.Finally,these functions are tested.The test results show that the module can solve the main design objectives of subject management,quality control management and drug management.