Exploitation And Application Of Clinical Trial Dat Management System

Clinical trial is the most important instrument to explore the security and validity of new medicine and therapeutics; it can enhance the medical technology development level. To ensure the true reliability and scientific credibility of clinical trial results, and to manage clinical trial data much more standard, researchers need the criterion and guidance of correlated policy statutes and inspections coming from governmental institutions. On the other hand, researchers also need the relevant clinical trial data management system to carry out high efficient and standard clinical trial data management.CDMS(Clinical Data Management System) is an important tool of standard clinical trial data management, the system criterion degree decides the level of the whole clinical trial data standard management. At present, there are relevant standards of CDMS and a lot of international excellent clinical trial data management software (such as Oracle Clinical), but most of them are very expensive, and hardly used well in our country because of the language problem. Now the exploitation and application of CDMS just start in our country, the degree of electron and standardization of data management is low.EpiData 3.0 is free data entry and management software. It is one of the softwares used widely in small new clinical trial data collection. It can create the data entry interface like pCRF (paper Case Report Form). People can finish data entry on one page and use it expediently; EpiData has broad using market in our country. But it is single-user program and no network version; it also has number limits of fields and records, so it can hardly be used in large-scale data collection. According to the high-level need of clinical trial data management, the writer hopes to develop a new all-purpose clinical trial data management software through fusing the strong points of Epidata and other software; and it can fit domestic market much more.Research Purpose: The writer explores the mode of domestic clinical trial data standard management system, and develops this relative all-purpose CDMS. Research course: The paper reviewed the developing trend and actuality of present global clinical data standard management through materials, and discussed the elements of clinical data standard management. It also described the standard and the data structure mode of current CDMS. The writer edited the program code with Visual Basic 6.0, and carried out the data's storage and management by network DBS SQL Server 8.0. The system tested by data manager from WHO/TDR CDMC (World Health Organization / Tropical Disease Research Clinical Data Management Center), and the writer revised the software based on the questions which they asked.Research result: The main functions of Clinical Trial Data Management System's exploitation are totally finished now, which refers to the criterion and demands of clinical trial data, including safety management,eCRF designing,twice data entry,comparing instantaneously while second data entry,changing trails,records'integrality checkout, variables library creating, generating query forms automatically and data output etc.The standardization of clinical trial data management is a trend of development of clinical trial; researchers should increase standard and electronic research of clinical trial data management, and advance the development of domestic CDMS. The writer believes the research would enhance the level of domestic clinical trial and its international competition.