Gaois

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  1. LAW · SOCIAL QUESTIONS|health|pharmaceutical industry

    #644047

    IATE #3518694
    duine éagumasaithe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    nicht einwilligungsfähige Person
    de
    Definition Person, die aus anderen als aus Altersgründen gemäß den nationalen Rechtsvorschriften des betroffenen Mitgliedstaats nicht in der Lage ist, eine Einwilligung nach Aufklärung zu erteilen Reference COM-Internes Dokument SANCO-2012-80155-02-01
    incapacitated subject
    en
    Definition "subject who is, for other reasons than the age of legal competence to give informed consent [ IATE:3535646 ], legally incapable of giving informed consent" Reference "Proposal for a Regulation on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, COM/2012/0369 final, CELEX:52012PC0369/EN"
    participant incapable
    fr
    Definition "participant qui, pour des motifs non liés à l’âge légal pour donner son consentement éclairé [ IATE:3535646 ], est dans l’incapacité légale de donner son consentement éclairé" Reference COM-Document interne: SANCO-2012-80155-00-04Règlement relatif aux essais cliniques de médicaments à usage humain