PROCESS MODEL OF THE TRIAL SITE QUALITY MANAGEMENT SYSTEM

The necessity of ensuring the implementation of planned objectives concerning quality, costs and timing of clinical trials (CT) in a modern complexand changing environment determines the importance of a systematic approach to CT quality management. Thus, the issues of designing based onthe process approach quality management system (QMS) have become an actual task at trial site. To build a process model of a trial site QMS we usedIntegration Definition Function Modeling methodology. General approaches to the process model of QMS have been developed, its core processes havebeen explicated, its input, outputs, and their interrelation according to the application of ISO 9001:2015 have been implemented. The main processchart which includes five base CT processes has been designed. The consistency of these processes has been substantiated and described with thegeneral framework for QMS implementation at trial site provided. Our model can be used at trial sites as a framework for designing QMS in the processof ISO standards implementation.Keywords: Trial site, Quality management system, Process model