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(4) ‘Non-interventional study’ means a clinical study other than a clinical trial;… +
(4) ‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpos… +
(43) The members of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) ha… +
(46) ‘investigational device’ means a device that is assessed in a clinical investigation;… +
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(5) Eine klinische Prüfung darf in Notfällen nur durchgeführt werden, wenn die Voraussetzungen des Artikels 35 der Verordnung (EU) Nr. 536/2014 vorlie… +
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(5) Study Design means a description of the manner in which the clinical trial will be conducted, including the following information:
(i) Interventi… +
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(57) ‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laborat… +
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(6) Die betroffene Person oder, falls diese nicht in der Lage ist, eine Einwilligung nach Aufklärung zu erteilen, ihr gesetzlicher Vertreter muss ausd… +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 60 – 62 +
(60) ‘adverse event’ means any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward cl… +
(64) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-e… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 67–69 +
(67) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-e… +
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(8) The term ‘‘de novo classification request’’ means a request made under section 513(f)(2)(A) with respect to the classification of a device.… +
(A Memo for FDA Personnel on Current Good Manufacturing Practice For Human Use Pharmaceuticals)
[...]
6) Are the use of ditto marks and arrows for red… +
(b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may inclu… +
(b) Review of safety information. The sponsor must promptly review all information relevant to the safety of the drug obtained or otherwise received b… +
(c)
(1) IND safety reports. The sponsor must notify FDA and all participating investigators (i.e., all investigators to whom the sponsor is providing … +
(c) Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements… +
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(c)‘non-interventional trial’: a study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the mark… +
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(d) Followup.
(1) The sponsor must promptly investigate all safety information it receives.
(2) Relevant followup information to an IND safety report … +
(d) Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is adminis… +
