Clinical Data Acquisition Software Based On C# Technology

In many aspects of the drug discovery and development, evidence from multi-center clinical trials is key to the interpretation of the safety and efficacy of new drugs. However, the quality of clinical research is primarily determined by the quality of clinical data generated from these trials. Intelligent and efficient clinical data management helps to make this happenTo develop a set of advanced and standardized clinical data capture system after studying the operation system of the clinical data management softwares widely accepted in China and worldwide.Closely around the subject of drug clinical trial management (GCP) requirements. First, learning about the basic infrastructure of widely used clinical trial data capture softwares and the development tool by looking through related literature located from CNKI search.. Second, Using Visual Studio.NET and C# to develop a new clinical data capture system. This system was based on C/S/S (RICH/CLIENT) rich client framework, Oracle 10G database as a platform for running in the background, ensure stable running data, Webservice for environment in the middle is a front-end program access, ensure the safe and convenient clinical data acquisition system. Lastly, he system was then put on pilot trials by researchers from the Tianjin Institute for Clinical Evaluation. Improvement was made basing on users’feedback.According to clinical drug trial code for quality management requirements, clinical data acquisition software developed by the subject should include: remote clinical data collection function, Division of clinical trial data and statistics functions, user-rights management features, modifying trace tracking features, supporting researchers Office functions.Clinical data acquisition system developed to meet researchers’remote offsite timely, accurate clinical data entry, or you can simple statistical evaluation of experimental data, and export the appropriate file format and docking SAS software, later large-scale data statistical calculations. Clinical data acquisition system can be further enhanced through the development of clinical drug research quality level, and help to advance medical development and internationalization.