Zupanets K. Theoretical, scientific and practical foundations of clinical trial management at place of study

A general model of an integrated quality management system of clinical trials of drugs was proved and developed for the first time. The concept of an 'integrated management system of clinical trials of drugs' was introduced. The approaches for the implementation of such a system and strategic ways of risk management of clinical trials at the tests' locations were formulated. The practical approaches to the identification of risks to the quality of clinical trials of drugs at the tests' locations were developed; the system of indicators and methods of risk management for the organization of bioequivalence (BE) studies at the tests' locations was scientifically proven. The algorithms of registration of side reactions and side effects and the influence of concomitant therapy in clinical trials of drugs were created. The eCRF model was developed for the first time and also methods of its validation in BE studies was created. The scheme of the functional distribution of data management procedures performers while working with eCRF was proposed. The generalized structural model, that links key aspects of subjects' protection and factors of management system of clinical trials of drugs, was developed. According to the results of the survey the common methodological approaches for patients' involvement and protection at the tests' locations were offered.