| With the rise of the emerging discipline of computer technology, Internet technology, the rapid development of IT, evidence-based medicine, digital medical data mining and other traditional medical research also need to use new technology from a new angle of departure to continue to promote their own development. Chinese medicine is a traditional medicine, many diseases or seems difficult to cure diseases since ancient times, how to prevent or treat the records or drug in clinical played a miraculous. But these have been applied hundreds or even thousands of years Chinese medicine has not been recognized by some Western physicians, they think that part of Chinese medicine is no clinical research data to support, not scientific. In order to enhance the impact and status of TCM in the international medical, TCM clinical efficacy evaluation studies and clinical observational studies of traditional Chinese medicine in the "real world" has become one of the focus and orientation of the Chinese Medicine Clinical Research. In these studies, a large number of clinical trial data, how to make use of effective quality modern advanced computer technology to collect, manage, analyze these data as many researchers need to consider and overcome a problem.Objective:The purpose of this study is to understanding of combing the domestic and international clinical research data quality legal regulations and standards, complete control of the development of domestic and international Good Clinical Data Management System Overview Summary absorbing domestic and foreign excellent data management system features; explore the development suitable for the collection, management of Chinese medicine treatment of stroke observed data, auxiliary clinical staff supervision, enhance data sharing and information exchange between members of the clinical trial centers and group, but also in the control of data quality at the same time substantially to improve the management efficiency of the clinical data management system.Methods:mature experience to learn from home and abroad, summed up the characteristics of the data management software at home and abroad, with reference to international laws and regulations relating to clinical trials and CRO industry standards, combined with the disease characteristics of the stroke, the data characteristics and treatment processes, the use of Dreamweaver8.0Web authoring software, SQL Sever2000database and JavaScript technology development of Chinese medicine prevention stroke clinical data management system. The system will function principle of data security, reliability, consistency and EpiData3.0data management software to determine the validity and applicability of the system, and applied to technology transfer and community outreach TCM prevention and treatment of stroke disease14clinical trial centers in the research topic, and to verify the availability and stability of the system.Results:In this study, from the leprosy disease, medical data, the three angles of the "real world" clinical research data, summarize large volumes of data and dissemination of research topics in Chinese medicine to combat stroke community structure forms, privacy, data integrity and the timeliness and other data characteristics. Through the use of modern means of science and technology, standardization of clinical data management system requirements and foreign software features based on the actual situation of Chinese medicine to combat stroke community outreach research topics, from data security, reliability, consistency and timely and other aspects of the design and development of TCM prevention and treatment of stroke disease community outreach research project of clinical data management system. The system uses the characteristics of the network to solve the problem of group geographical, resource sharing, improved work efficiency; subjects management, personnel management, data management module permissions role differentiation, dual parity entry the data traces of functions, improve the quality of the data to ensure reliability and accuracy of the results of clinical trials.Conclusion:our clinical data management, in particular regulations and industry standards for electronic data management is not perfect, leading to the domestic data management system compared with foreign countries there is some discrepancy in the data quality management, the establishment of the rule of law in combination with the actual situation in China as well as different experts in the field of further improved. TCM prevention and treatment of stroke disease clinical data management system for Chinese medicine prevention of stroke technology transfer and community outreach research project, has certain advantages in building a single test data management, but there are still a lot of improvement and development space, from the clinical data the breadth and depth of management to further study how to build into a platform for multi-project, the whole process of TCM clinical data management system. |
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