THE ROLE OF CLINICAL RESEARCH SUPPORT CENTERS IN ENSURING COMPLIANCE WITH THE ETHICAL PRINCIPLES OF CONDUCTING CLINICAL TRIALS IN POLAND – SYSTEMATIC EXPERIENCES AND STATE OF KNOWLEDGE
THE ROLE OF CLINICAL RESEARCH SUPPORT CENTERS IN ENSURING COMPLIANCE WITH THE ETHICAL PRINCIPLES OF CONDUCTING CLINICAL TRIALS IN POLAND – SYSTEMATIC EXPERIENCES AND STATE OF KNOWLEDGE

Summary/Abstract: Background: Clinical trials are a fundamental component of medical progress; however, they require strict adherence to ethical and legal standards. In Poland, these responsibilities are regulated by national legislation, the Declaration of Helsinki, and Good Clinical Practice (GCP) guidelines. Nevertheless, organizational fragmentation and variability in research quality across institutions have limited the efficiency and ethical coherence of clinical studies. To address these challenges, the Medical Research Agency (ABM) established the Polish Clinical Trials Network (PCTN), which includes the development of Clinical Research Support Centers (CWBK) and, more recently, Regional Centers for Digital Medicine (RCMC). Aim of the study: This review aims to analyze the role of CWBK in ensuring compliance with ethical stand ards in clinical trials conducted in Poland, with particular attention to their organizational structure, quality management systems, and the implementation of the ABM Model Standard CWBK 3.0. Material and methods: A narrative review was conducted based on publicly available sources, including official ABM documentation, national legal acts, and information published on CWBK and RCMC websites. Additional literature addressing the ethical, regulatory, and operational aspects of clinical trial management in Poland was analyzed to identify key determinants of ethical compliance. Results: The review and state-of-the-art analysis revealed that CWBK play a pivotal role in maintaining ethical integrity through standardized procedures, centralized quality management, and comprehensive investigator support. The Model Standard CWBK 3.0 defines the minimum organizational and staffing re quirements, ensuring transparency, participant safety, and harmonization of documentation across centers. Furthermore, RCMC complement this system by introducing secure digital infrastructure, thereby enhancing data quality, interoperability, and compliance with data protection regulations. Conclusions: The integration of CWBK and RCMC within the PSBK network represents a milestone in the ethical governance of clinical research in Poland. This model enhances transparency, strengthens researcher accountability, and ensures participant safety while aligning national practice with European standards of responsible research conduct.

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