The influence of the regulatory system on the study design and data management practices in clinical trials

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dc.contributor.authorYashchenko, Mariia
dc.contributor.authorYurochko, Tetiana
dc.contributor.authorSoroka, Ivan
dc.date.accessioned2022-09-01T10:35:04Z
dc.date.available2022-09-01T10:35:04Z
dc.date.issued2022
dc.description.abstractThe 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. 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: The case study presented effective cross-border cooperation between Ukrainian and European actors. Despite the gaps in Ukrainian legislative framework on medical devices, complex solutions on employment of the most stringent regulatory provisions led to appropriate study design. Usage of the highly compliant electronic data capture led to fast-track study start-up and solid clinical data collection. Conclusions: Publications on real-life regulatory-dependent clinical trials conduct might be essential to innovate the regulatory system in Ukraine. The cross-border cooperation might assist the advancement of clinical trials industry in Ukraine. Gaps in medical devices regulations in Ukraine impede the context-specific clinical trials solutions for biotech industry in Ukraine. The regulatory framework and practice in Ukraine may be perceived as externally driven due to gaps in medical devices regulations, lack of capacities of domestic notified bodies and business interests of Sponsors.en_US
dc.identifier.citationYashchenko M. The influence of the regulatory system on the study design and data management practices in clinical trials / Yashchenko M. V., Yurochko T. P., Soroka I. M. // Wiadomosci Lekarskie (Warsaw, Poland : 1960). - 2022. - Vol. 75, Issue 5. - P. 1192-1196. - https://doi.org/10.36740/WLek202205125en_US
dc.identifier.issn0043-5147
dc.identifier.urihttps://doi.org/10.36740/WLek202205125
dc.identifier.urihttps://ekmair.ukma.edu.ua/handle/123456789/23735
dc.language.isoenuk_UA
dc.relation.sourceWiadomosci Lekarskie (Warsaw, Poland : 1960)pl_PL
dc.statusfirst publisheduk_UA
dc.subjectclinical trials designen_US
dc.subjectmedical devicesen_US
dc.subjectclinical trials regulationen_US
dc.subjectclinical data managementen_US
dc.subjectarticleen_US
dc.titleThe influence of the regulatory system on the study design and data management practices in clinical trialsen_US
dc.typeArticleuk_UA
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