Research On Clinical Trial Data Management System Based On Cloud Computing

Clinical data management runs through all stages of clinical research and plays a decisive role in the accuracy and authenticity of test data.In view of the lack of effective data quality management system,data quality evaluation standards and the collection,analysis and management of adverse events in China’s clinical trial data management system,this paper designs and implements a clinical trial data management system based on cloud computing.The main research contents are as follows:1.Build a data quality management system.This paper constructs the data quality management system by means of quality manual,procedure documents,operation instructions and quality records,continuously coordinates,quality monitoring,information management,quality management system audit and management review,realizes the effective operation of the quality management system,ensures that various factors and links of data quality results are under comprehensive control and management,and clinical research data are always maintained at a controllable and reliable level.2.Establish data quality evaluation standards.In this paper,the quality evaluation standards are established for the test personnel,equipment and data respectively,so as to realize the quality evaluation of the rationality,attribution,readability,simultaneity,originality and accuracy of the clinical data.The random forest model is adopted,with the constructed quantitative data quality evaluation standard as the input and the qualified data quality as the output,so as to realize the overall evaluation accuracy rate of the clinical data quality of93.3%,The time of data quality evaluation is shortened from 2 days to 1second,which greatly saves manpower and shortens the test time.3.Establish the accuracy of adverse event collection.This paper strengthens the collection,analysis and management of adverse events in the clinical trial data system,subdivides the accuracy of adverse event collection into high accuracy,medium accuracy and low accuracy,defines the scope of adverse event collection and verification,retains important safety information in clinical research,and supports the reliable conclusions of the trial.4.Establish a clinical trial data management system based on cloud computingThis paper adopts the deployment mode of cloud computing platform,C / s development mode,Spring MVC architecture and Cassandra database development technology to realize the modules of clinical data recording,monitoring,analysis,centralized randomization,subject management and adverse event management of the system,and tests them from the two dimensions of performance and function respectively.The test results show that the system meets the on-line requirements and verify the effectiveness of the system.