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Master Thesis

Cadre juridique et aspects pratiques de l’investigation clinique d’un système connecté pour l’administration d’un médicament

Abstract : In our daily life as well as in the healthcare environment, more and more so-called connected objects are put on the market. A medical device used to administer a medicinal product and linked to a mobile application form the connected system described in this thesis. To demonstrate that using the systemimproves the adherence of the patients to their treatment, a clinical investigation is planned to be conducted. The regulatory framework corresponding to each piece of the connected system needs to be taken into account: the directive on clinical trials and the regulation soon to be applicable, the directive on medical devices and the regulation just published, andalso the good clinical practice, the regulation on data protection. Some more practical aspects are also described such as the documents to provide or the points to consider when designing the clinical study.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01829862
Contributor : Bu Carreire Université de Bordeaux <>
Submitted on : Wednesday, July 4, 2018 - 12:58:53 PM
Last modification on : Saturday, July 14, 2018 - 1:18:55 AM
Long-term archiving on: : Monday, October 1, 2018 - 1:53:30 PM

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  • HAL Id : dumas-01829862, version 1

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Gaëlle Le Provost. Cadre juridique et aspects pratiques de l’investigation clinique d’un système connecté pour l’administration d’un médicament. Sciences pharmaceutiques. 2018. ⟨dumas-01829862⟩

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