Gaois

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  1. SOCIAL QUESTIONS|health|medical science

    #527383

    IATE #156803
    bróisiúr imscrúdaitheora Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Information für den Prüfer
    de
    Comment Term defined --
    IB | investigator's brochure
    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 --