The Research Of Clinical Trial Management System

The networked management of the drug clinical trial can effectively integrate multiple resources, optimizing allocation of human resources, help to improve the quality of clinical research, reduce development costs, shorten development cycles, make the clinical research process more standardized,economic and efficient. Contract Research Organization (CRO) is one of the major research institutions of the drug clinical trial. It has a wealth of research experience, an extensive network of sample and a strict standard operating procedures. Domestic CRO conducting clinical research services with low cost and vast market, abundant sample resources and many other advantages. But it's have some problems, for example, lack of the strong support of networked management in clinical trials, project management difficulties, the research process deviated from the norms, a serious waste of human resources and other issues.In this background, we combine the norm of drug clinical trial,the process of CRO's actual clinical trials,the functional requirements of CRO and the sponsor, research into the overall structure of the network of clinical trial management system,the key technology of system's realize and the support technology for system's running. We developed an internet-based clinical trial management system-CTMS. The hardcore of CTMS is the process of clinical trial and experimental data.Firstly, in this paper, we analysis the present situation of foreign clinical study data management system, propose CTMS's general structure and hierarchical model combined with the regulatory requirements of clinical trials, the actual process of clinical trials, as well as user's functional and non-functional requirements.Secondly, with the hardcore clinical trial project in this paper, we design the system's process of clinical tria,the management system of clinical trial s'base data or common basic data,the express layer structure of project and the data extraction mechanism. To achieve key technologies such as the project process control, basic data management, project status getting, system extension support. Thirdly, according to users' non-functional requirements for clinical trials' management systems, we constructed system data security system and multi-language support system, enhanced support for the internationalization of CTMS.Lastly, united characteristic of CRO's network applications, we designed the CTMS'actual operation of the network architecture. At last, CTMS'function was validated by running...