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
Rattachement africain : pl. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
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 standards 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.Materials 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 requirements, 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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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- 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
- Date Crossref
- 02/02/2026
- Éditeur
- Index Copernicus
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Opole University of Technology pays non établi dans la noticeUniversité ou école supérieure
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Cardinal Stefan Wyszynski University in Warsaw pays non établi dans la noticeUniversité ou école supérieure
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Wroclaw Medical University pays non établi dans la noticeUniversité ou école supérieure
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Lower Silesian Cell Transplantation Centre Ltd Department of Legal Advisors pays non établi dans la noticeEntreprise
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WSB Merito University in Opole Department of Management and Logistics pays non établi dans la noticeUniversité ou école supérieure
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Faculty of Rehabilitation Cardinal Stefan Wyszynski Institute of Cardiology in Warsaw pays non établi dans la noticeUniversité ou école supérieure
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Department of Nursing Faculty of Nursing and Midwifery Division of Anesthetic and Surgical Nursing pays non établi dans la noticeUniversité ou école supérieure
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Olawa pays non établi dans la noticeInstitution
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Faculty of Health Sciences Department of Nursing pays non établi dans la noticeUniversité ou école supérieure
Opole University of Technology, Cardinal Stefan Wyszynski University in Warsaw et Wroclaw Medical University, avec 6 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.