Data Management System Design And Applied Research In Clinical Trials Of Newly-developed Drug Of Chinese Materia Medica

Objective:To develop to be a consistent with Chinese GCP regulations, to be to acceptable international standards and to be adaptive to Newly-developed drug of chinsese materia medica clinical trial data management system; to establish a large sample and multi-center traditional Chinese drug clinical trials'standardization of data management pattern.Methods:â‘ In accordance with SFDA,ICH and FDA Promulgated regulations and Clinical Data Management Association of the United States established Good Clinical Data Management Practices; in connection with the characteristics of a large sample and multi-center traditional Chinese drug clinical trials; by using modern information technology, computer technology, INTERNET technology and electron-capture technology, develop Newly-developed drug of chinsese materia medica clinical trial data management system, which is integrated with long-distance records, remote monitoring, data analysis, centered randomized and Trying management. Through the overall test, the system achieves the designed goal function.â‘¡Through being widely used and analyzing the current disadvantage in the process of clinical trials data management, establish a large sample and multi-center traditional Chinese drug clinical trials'standardization of data management pattern in the process of data management of a clinical trial in "Eleventh Five-Year" National Key Project, which is a "combined treatment of Chinese medicine intervention study about diabetic retinopathy". It is combined with a an independent evaluation of the data center, an independent data monitoring group, a detailed data management plan, a dynamic quality control system, a serial of data management SOP, a centered randomized system and the norms of the subjects management.Results:It has realized a series of functions, for example e-CRF, Chinese medicine symptom quantification, dynamic management of drugs, laboratory data synchronization, research's management, data record, modification, tracing, remote query, monitoring,information sharing, data authenticity and reasonable assessments, assessment syndrome evaluation, safety assessment, final report of the formulation, centre randomized, random Thorough hideaway, effective management of subjects, and so on. The research has developed a large sample and multi-center traditional Chinese drug clinical trials'standardization of data management pattern, which has controlled all aspects of clinical trial data management process to ensure data authenticity, reliability, traceability and efficiency.Conclusion:The newly-developed drug of chinsese materia medica clinical trial data management system has completely achieved designed goal of the system, which has improved the data management quality and the efficiency; a large sample and multi-center traditional Chinese drug clinical trials'standardization of data management pattern will have raised electronization, information, standardization and dynamic quality control in the entire process of data management,as the same as it improveS quality and efficiency of the data management in clinical trial.