Ratushna K. Scientific and methodical approaches to data management in clinical researches of medicines

For the first time there were theoretically substantiated and developed methodical approaches to proper data management on the bases of integration of modern requirements to clinical trial organization and concept positions of project management considering international quality management standards. For the first time there were developed the structure of informational system of clinical trials and the process model of clinical data management within quality management system at the trial site. Risk factors and types of risks for clinical trial data were investigated. The model of risk management process and methodical approaches to forecasting risks were proposed. Methodical approaches to process regulation at the trial site were adapted, on the bases of which range of data management standard operation procedures were developed.