%0 Journal Article
%T La traducci車n de g谷neros jur赤dico-administrativos en la gesti車n de ensayos cl赤nicos multinacionales en Espa a: m芍s all芍 del protocolo
%A Lorenzo Gallego-Borghini
%J Panace@ : Revista de Medicina, Lenguaje y Traducci車n
%D 2012
%I Trem谷dica: Asociaci車n Internacional de Traductores y Redactores de Medicina y Ciencias Afines
%X La gesti車n de ensayos cl赤nicos multinacionales en Espa a requiere que se traduzcan diversos documentos de car芍cter jur赤dico, administrativo y econ車mico; los dos m芍s importantes y que m芍s atenci車n han recibido son el protocolo y el consentimiento informado, pero hay otros que tambi谷n conforman la labor del traductor que trabaja para la industria farmac谷utica. A partir del corpus recopilado por el autor en diez a os de experiencia, este art赤culo clasifica y analiza los dem芍s g谷neros jur赤dico-administrativos que se traducen para un ensayo cl赤nico: la enmienda al protocolo, la resoluci車n administrativa, los dict芍menes de los CEIC, la conformidad del centro, el poder de representaci車n y el contrato de ensayo cl赤nico. Se aportan consejos, pistas y comentarios para acometer la traducci車n de estos documentos. ------------------------------------------- Translation of legal and regulatory documents for multinational clinical trials in Spain: more than just protocols. Managing a multinational clinical trial in Spain requires the translation of several legal, regulatory and financial documents. The two most important texts, which have received the most attention, are the protocol and the patient information sheet/informed consent form, but translators who work in the pharmaceutical industry also deal with other types of documents. Based on the corpus compiled by the author over his ten years of experience, this article classifies and analyzes the other legal and regulatory genres which are translated for clinical trials: the protocol amendment, the letter of delegation, the Ethics Committee opinion, the site management agreement, the power of attorney and the clinical trial agreement. The author provides advice, tips and comments to assist in translating these texts.
%K traducci車n
%K ensayo cl赤nico
%K investigaci車n cl赤nica
%K enmienda
%K resoluci車n
%K dictamen
%K aclaraciones
%K contrato
%K translation
%K clinical trial
%K clinical research
%K amendment
%K regulatory decision
%K opinion
%K clarifications
%K clinical trial agreement
%U http://www.tremedica.org/panacea/IndiceGeneral/n36-tradyterm_LGallegoBorghini.pdf