Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #623160

    IATE #1237287
    imscrúdaitheoir Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Prüfer | klinischer Prüfer
    de
    Definition Person, die für die Durchführung der klinischen Prüfung in einer Prüfstelle verantwortlich ist Reference "Richtlinie 2001/20/EG zur Angleichung der Rechts- und Verwaltungsvorschriften der Mitgliedstaaten über die Anwendung der guten klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Humanarzneimitteln CELEX:32001L0020/DE Verordnung (EU) Nr. 536/2014 über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG, Art.2 Nr.15; ABl. L_158/2014, S.1 CELEX:32014R0536/DE"
    investigator | clinical trial investigator | clinical trial investigators | clinical investigator
    en
    Definition individual responsible for the conduct of a clinical trial at a clinical trial site Reference "Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance)Text with EEA relevance"
    Comment "The term 'investigator' also appears in Regulation (EU) 2017/745 on medical devices and in Regulation (EU) 2017/746 on in vitro diagnostic medical devices, with slightly different definitions."
    expérimentateur
    fr
  2. SOCIAL QUESTIONS|health|medical science

    #602349

    IATE #156803
    bróisiúr imscrúdaitheora Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Information für den Prüfer
    de
    Comment Term defined --
    investigator's brochure | IB
    en
    Definition compilation of the clinical and non-clinical data on the investigational medicinal product or products which provides the investigators and others involved in the trial with information to facilitate their understanding of the rationale for, and their compliance with, key features of the protocol, such as the dose, dose frequency/interval, methods of administration, and safety monitoring procedures Reference "COM-EN, based on:Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, CELEX:32014R0536/EN"
    brochure pour l'investigateur
    fr
    Comment Term defined --