Development And Application Of Clinical Trial Project Management System

With the rapid development of computer technology, the penetration of networktechnology and database management technology into all areas of clinical trials, varioustypes of clinical trial design and management software systems are developing rapidly.At present foreign mature clinical trial management software is mostly based ontraditional relational database, but it can’t satisfy the uncertainty of acquisitionparameters in clinical trials, and it is not promoted widely in the domestic because of thelanguage problems. In addition, the clinical trial approval cycle is long, and theparameters collected and storage standards of different research institutions are not thesame, thus it is difficult to achieve information sharing and exchange between each other.Therefore, the development of clinical trials management software system to adapt to ourcountry, standardize the process of clinical trials, improve the efficiency andtransparency of clinical trials, which is crucial to drug safety of1.3billion people andwill have a very important significance to participate the international competition anddevelop high quality drugs.Based on the study data tabulation model domain (SDTM) and Cassandra database,this paper designs and implements a web-based customizable clinical trials collaborationand management system (CTCMS), which can manage multicenter clinical trials. CTCMScontains the configuration management of clinical trial, dynamic random numberallocation, subjects and data management, progress monitoring and other functions, and itis suitable for a variety of clinical areas. In this paper, the background and current situationof the development of clinical trial management software system is analyzed and discussedfirst and then a number of problems of current multicenter, large sample clinical trials isdescribed in details; Secondly, the storage model in the database, the extension of systemmodel and SDTM domain have been described, the advantages of Cassandra VS traditionalOracle database are analyzed, as well as cross-regional and uncertainty of database tablesin the clinical trials, CTCMS will combine SDTM domain with Cassandra database tosolve inadaptability between the relational database model and multicenter clinical trial, and achieve a dynamic column-oriented data storage model; Finally, the comparison ofbatch writes of multi-threading performance between Oracle and Cassandra, it has beenillustrated that CTCMS based on Cassandra has a good read and write performance.This paper uses Cassandra to store and manage clinical trial data, it allows addingcolumns dynamically according to actual needs, achieving flexible patterns and applyingto different areas of clinical trials; the application of SDTM domain helpsinformation-sharing between different research institutions and researchers, and alsocontributes to mutual recognition and data exchange with the developed countries.