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

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dc.contributor.author Yashchenko, Mariia
dc.contributor.author Yurochko, Tetiana
dc.contributor.author Soroka, Ivan
dc.date.accessioned 2022-09-01T10:35:04Z
dc.date.available 2022-09-01T10:35:04Z
dc.date.issued 2022
dc.identifier.citation Yashchenko 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/WLek202205125 en_US
dc.identifier.issn 0043-5147
dc.identifier.uri https://doi.org/10.36740/WLek202205125
dc.identifier.uri http://ekmair.ukma.edu.ua/handle/123456789/23735
dc.description.abstract 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. 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.language.iso en uk_UA
dc.subject clinical trials design en_US
dc.subject medical devices en_US
dc.subject clinical trials regulation en_US
dc.subject clinical data management en_US
dc.subject article en_US
dc.title The influence of the regulatory system on the study design and data management practices in clinical trials en_US
dc.type Article uk_UA
dc.status first published uk_UA
dc.relation.source Wiadomosci Lekarskie (Warsaw, Poland : 1960) pl_PL


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