The analysis of the current state of quality management tools implementation in clinical trials of drugs in Ukraine




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.

Author Biographies

T. Yu. Kolodyezna, National University of Pharmacy

postgraduate student of the Department of Clinical Pharmacology and Clinical Pharmacy

O. S. Popov, National University of Pharmacy

Candidate of Medicine (Ph.D.), teaching assistant of the Department of Clinical Pharmacology and Clinical Pharmacy

V. Ye. Dobrova, National University of Pharmacy

Candidate of Medicine (Ph.D.), teaching assistant of the Department of Clinical Pharmacology and Clinical Pharmacy


Zupanets, K. O., Dobrova, V. Ye., Proskurnia, O. M. (2015). Upravlinnia, ekonomika ta zabezpechennia yakosti v farmatsii, 4(42), 60–66.

Zupanets, K. O., Dobrova, V. Ye. (2015). Upravlinnia, ekonomika ta zabezpechennia yakosti v farmatsii, 6(44), 49 – 57.

3. Guideline for Good Clinical Practice. ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). (2015). International Conference оn Harmonisation оf Technical Requirements for Registration оf Pharmaceuticals for Human Use. Available at:

4. ISO 9001:2015 Quality management systems — Requirements. (2015). ISO, 40.

Suprin, M., Chow, A., Pillwein, M., Rowe, J., Ryan, M., Rygiel-Zbikowska, B., … Tomlin, I.(2019). Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development. Therapeutic Innovation & Regulatory Science, 53(1), 36–44.

Tantsyura, V., Dunn, I. M., Fendt, K., Kim, Y. J., Waters, J., & Mitchel, J. (2015). Risk-Based Monitoring. Therapeutic Innovation & Regulatory Science, 49(6), 903–910.

Callery-D’Amico, S., Sam, L. M., Grey, T. H., & Greenwood, D. J. (2016). TransCelerate’s Clinical Quality Management System. Therapeutic Innovation & Regulatory Science, 50(5), 530–535.

Meeker-O’Connell, A., Borda, M. M., Little, J. A., & Sam, L. M. (2015). Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework. Therapeutic Innovation & Regulatory Science, 49(5), 615–622.

Zupanets, К. О., Dobrova, V. Ye. (2016). Process model of the trial site quality management system. Asian Journal of Pharmaceutical and Clinical Research, 9 (3), 225–228.

Zupanets, E. A., & Dobrova, V. Y. (2016). The analysis of specialists’ opinion on the implementation of concept of risk management in clinical trials of drugs. Zaporozhye Medical Journal, 3.

Vereshak, V., Dobrova, V., Proskurnia, O. (2018). Management system improvement of the research centres by FMEA implementation. Management and entrepreneurship: trends of development, 4(6), 8–19.

ICH Q9 «Risk management». (n.d.). Available at:

ICH Q10 «Pharmaceutical quality system». (n.d.). Available at:

Zupanets, I. A., Dobrova, V. Ie., Popov, O. S., Kozyrieva, O. M., Sumets, O. M. (2019). Materialy dopovidei VIII naukovo-praktychnoi konferentsii z mizhnarodnoiu uchastiu (01.11.2019). Kharkiv: Monohraf, 320–322.

Dobrova, V. Y., Ratushna, K. L. (2019). ISO 9001:2015 AND updated guideline for good clinical practice: considerations for synergic application. Zbirnyk materialiv XIII naukovo-praktychnoi konferentsii “Upravlinnia yakistiu v farmatsii” (17.05.2019), 47.





Clinical Pharmacology and Pharmacotherapy