THE INFLUENCE OF THE REGULATORY SYSTEM ON THE STUDY DESIGN AND DATA MANAGEMENT PRACTICES IN CLINICAL TRIALS.

Objective: The aim: To review real-life regulatory-dependent study design and data management practices of post marketing multicenter studies of medical devices conducted in 2021 in Ukraine and Poland.

Patients And Methods: Materials and methods: This article presents the case study of 4 post marketing multicenter studies of medical devices conducted in 2021 in Ukraine and European Union.

Results: Results: The case study presented effective cross-border cooperation between Ukrainian and European actors.