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<p><br /></p><h3>(MIABIS 2.0 Core, <span class="epub-section__item"><a class="epub-section__doi__text" href="https://doi.org/10.1089/bio.2015.0070">https://doi.org/10.1089/bio.2015.0070</a></span>)</h3><p>Study represents a set of samples brought together in the context of a research study. </p><p><br /></p><h3><span>REGULATION (EU) No 536/2014</span></h3><p><span style="color: rgb(0,0,0);text-decoration: none;"><a style="" href="https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf">https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf</a></span></p><p><span style="color: rgb(0,0,0);text-decoration: none;">“(1)‘Clinical study’ means any investigation in relation to humans intended:</span><br style="text-decoration: none;" /><span style="color: rgb(0,0,0);text-decoration: none;"> (a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;</span><br style="text-decoration: none;" /><span style="color: rgb(0,0,0);text-decoration: none;"> (b) to identify any adverse reactions to one or more medicinal products; or</span><br style="text-decoration: none;" /><span style="color: rgb(0,0,0);text-decoration: none;"> (c) to study the absorption, distribution, metabolism and excretion of one or more medicinal products;</span><br style="text-decoration: none;" /><span style="color: rgb(0,0,0);text-decoration: none;"> with the objective of ascertaining the safety and/or efficacy of those medicinal products;</span><br style="text-decoration: none;" /><br style="text-decoration: none;" /><span style="color: rgb(0,0,0);text-decoration: none;">(2)‘Clinical trial’ means a clinical study which fulfils any of the following conditions:</span><br style="text-decoration: none;" /><span style="color: rgb(0,0,0);text-decoration: none;"> (a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;</span><br style="text-decoration: none;" /><span style="color: rgb(0,0,0);text-decoration: none;"> (b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or</span><br style="text-decoration: none;" /><span style="color: rgb(0,0,0);text-decoration: none;"> (c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects. </span><br style="text-decoration: none;" /><br style="text-decoration: none;" /><span style="color: rgb(0,0,0);text-decoration: none;">[…]</span><br style="text-decoration: none;" /><br style="text-decoration: none;" /><span style="color: rgb(0,0,0);text-decoration: none;">(4) ‘Non-interventional study’ means a clinical study other than a clinical trial; ”</span><br style="text-decoration: none;" /><br /></p>
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