TRANSLATION OF CLINICAL RESEARCH TERMINOLOGY IN THE UKRAINIAN-ENGLISH CONTEXT: FROM AMBIGUITY TO UNIFICATION

This article examines the translation of clinical research terminology from Ukrainian to English, considering linguistic discrepancies and ICH GCP E6(R2) standards.The study identifies morphological, syntactic, and semantic differences between Ukrainian and English terms that complicate the translation of regulatory documents, such as protocols, reports, and informed consent forms.Ukrainian terms are often polysemous, descriptive, or multi-component, e.g., " " (investigational product), " " (primary endpoint), or " " (serious adverse event), while English terms are unified, concise, and functional.Inaccurate translation can lead to legal, ethical, and methodological issues, affecting participant safety, result reliability, and compliance with international regulators like the FDA and EMA.To address these challenges, three strategies are proposed: contextualization, use of unified glossaries, and adaptation.Contextualization tailors translations to document type and audience, ensuring accessibility for participants and precision for regulators.Glossaries standardize terminology, reducing variability, e.g., fixing "randomisation" for "."Adaptation addresses terms without equivalents, such as "controlled trial" for " ."Practical applications are illustrated with examples like "serious adverse event" and "blinding."The article highlights the importance of harmonizing Ukrainian terminology with international standards to support Ukraine's integration into global clinical research, particularly given the rise in international trials (over 200 in 2023, per Ukraine's Ministry of Health).Future research prospects include evaluating automated translation with CAT tools, analyzing reverse translation, developing bilingual glossaries, comparing language pairs, and studying translation's impact on participants' term perception.The work enhances translation practices, improves regulatory document quality, and ensures ethical standards in clinical research.