The analysis of the current state of quality management tools implementation in clinical trials of drugs in Ukraine
Keywords:clinical trial quality management system, quality management system, quality management tools, clinical trialsclinical trial quality management system, clinical trials
The specificity of the processes of organizing and conducting clinical trials (CT) determines the particular requirements for quality management systems (QMS) and their improvement. That is why there is a constant need to assess the effectiveness of CT quality management and determine the need to develop new QMS optimization tools that have been already implemented in the work.
Аim. To study the state of the implementation of quality management tools in CT of drugs and assess their use in practice.
Materials and methods. To identify problems and determine the need to create the ways to improve CT QMS we conducted a survey of 217 Ukrainian specialists working in the field of organizing and conducting CT.
Results. According to the respondents, the most used QT quality management tools to ensure the proper level of quality in organizing and conducting CT are monitoring / audit, and routine internal quality control. The assessment of the knowledge level about risk-based quality management tools has shown that the personnel carrying out the processes of organizing and conducting CT does not fully possess even basic knowledge about the proper use of CT quality management tools. The analysis of the QMS implementation in the practical work of the respondents’ organizations has shown an insufficient level of implementation of such systems and their certification.
Conclusions. Thus, it is advisable to perform work on the development of methods for the active implementation of risk-based tools into practice; it is necessary to train specialists in the field of CT according to the specialized professional and educational programs, as well as to use the wider implementation of QMS in organizations and their certification.
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