The Revelopment And Application Of Multi-center Drug Clinical Trial Management Information System

New drug clinical research in China is mostly based on multi-center cooperative way, Traditional multi-center clinical research process management for the center with paper records of artificial management mode, this way there is project management lack of timeliness. Incomplete data record, data transmission are not synchronized, design modify, data latches and blind state audit is difficult to perform statistical analysis, difficult operation, many problems such as nonstandard test drug management. Lead to bidders and regulatory project verification difficulties, they were unable to real-time tracking project progress, many times to repeat the test and so on, affect the quality of the drug clinical trial research process and reliability of the results.Drug clinical trials standardization and informatization management is the inevitable trend in the drug clinical trial development at home and abroad, establish the whole sex strong, safety, timeliness and authoritativeness of GCP regulations and application service information platform to improve the traditional management mode, to improve the regulation of the quantity and quality of information transmission, to improve supervision level and strength of test process, to ensure that the link of scientific, authenticity and ethical pharmaceutical research has important practical significance.This thesis in view of the multi-center clinical trials and the urgent need of information management system research the multicenter drug clinical trial process information management of the related key technology, main research contents and innovation of are:1.The development of multi-center clinical drug management based on the structure of Web information system, realize the drug clinical trial project information, subjects’ information, the main drug management, quality control, etc.) of information management.2.Realized the electronic CRF as the core of electronic drug clinical trial data management, including electronic CRF table (e-CRF) twice in the custom design, data entry, data consistency check corrections, query management, data management, electronic CRF function such as table data derived.3.Based on electronic CRF table derived data and professional medical statistical analysis software of the automatic interface, realize high-efficient and statistical analysis of the application of drug clinical trial data, shorten the cycle for drug clinical trial data processing, improve the efficiency of the GCP management...