Study Of The Clinical Data Management System And Application Of CDMS In The Clinical Data Regulatory Management

Clinical Data Management is the important component of Clinical Trial, which plays a crucial role in the whole process in the clinical Trial. Now not only true evaluation of the safety and effectiveness of new drug, but also high qualified clinical trial arises from the clean and high quality data. For the sake of the safety of the human who take the new drug to cure the diseases, and the sake of advantages of the subjects who participate the clinical trials, since 1990s when the ICH-GCP was established, amended and meliorated, clinical trials in many countries in the world have developed into a regulatory era. Meanwhile, FDA that is looked on as the representative of the developed countries' drug administration, issured a series of regulations, guidelines related to the clinical trial, which put forward a higher demands to the regulatory management of the clinical trial. The standards of the clinical data management are accordingly increased. The demands of the clinical data management are now clearly defined in the ICH-GCP and the Chinese GCP, because the rules in GCP of our government are more like principles than detailed regulations, which results to the different operation patterns in different pharmaceutical R&D institutions. Therefore a lot of problems now exist in the area of clinical data management. In another hand, the traditional paper form clinical data management pattern in domestic clinical trials also brought about the low efficiency and quality.This study comment on the current situation of domestic clinical data management, pointed out the problems in the process of the domestic clinical data management and the trend of international clinical data management, put forward the three basic measures which should take to achieve the regulatory clinical data management including: establish relative regulations which should be obeyed by all the participators in the clinical trials, develop perfect Standard Operation Procedure in each clinical trial and adopt regulation admissive data management systems.In view of the electronic development trend of the global clinical data management and the study reality, the paper reviewed the history of the clinical data management system. Considering the characteristic of the clinical trial and the relative regulations, bring forward that the object relation data management system (ORDMS) is the appropriate system that could be used in the regulatory clinical data management.In order to go deep to the importance of the regulatory clinical data management system...