{"id":18740,"date":"2018-03-09T09:07:25","date_gmt":"2018-03-09T09:07:25","guid":{"rendered":"https:\/\/www.deberes.net\/tesis\/sin-categoria\/comites-eticos-de-investigacion-cla%c2%adnica-y-buena-practica-cla%c2%adnica-en-europa\/"},"modified":"2018-03-09T09:07:25","modified_gmt":"2018-03-09T09:07:25","slug":"comites-eticos-de-investigacion-cla%c2%adnica-y-buena-practica-cla%c2%adnica-en-europa","status":"publish","type":"post","link":"https:\/\/www.deberes.net\/tesis\/etica\/comites-eticos-de-investigacion-cla%c2%adnica-y-buena-practica-cla%c2%adnica-en-europa\/","title":{"rendered":"Comit\u00e9s \u00e9ticos de investigaci\u00f3n cl\u00ednica y buena pr\u00e1ctica cl\u00ednica en europa"},"content":{"rendered":"<h2>Tesis doctoral de <strong>  Revuelta P\u00e9rez JavierAntonio <\/strong><\/h2>\n<p>En 1996 se afirman las recomendaciones de la conferencia internacional de armonizaci\u00f3n (ich) sobre buena pr\u00e1ctica cl\u00ednica por parte de la uni\u00f3n europea, eeuu y una armonizaci\u00f3n internacional en lo que se refiere al contexto legislativo de investigaci\u00f3n cl\u00ednica. Dichas recomendaciones adquieren rango legal en estados unidos y jap\u00f3n un a\u00f1o despu\u00e9s de su firma, mientras que en europa no adquieren rango legal hasta la publicaci\u00f3n de la directiva 2001\/20\/ce sobre ensayos cl\u00ednicos que ser\u00e1 de obligado cumplimiento antes de mayo de 2004. En pleno proceso de adaptaci\u00f3n legislativa a las recomendaciones ich de bpc, se plantea el determinar las diferencias existentes entre las mismas y la forma habitual de desarrollar proyectos de investigaci\u00f3n cl\u00ednica en los distintos pa\u00edses, con el fin de identificar cu\u00e1les van a ser los principales problemas que se pueden plantear de adaptaci\u00f3n al nuevo escenario existente en el momento en que las recomendacioens ich de bpc sean de obligado cumplimiento. Para ello se toma en consideraci\u00f3n a los comit\u00e9s \u00e9ticos de investigaci\u00f3n cl\u00ednica, que son organismos localizados fis\u00edcamente en una determinada zona geogr\u00e1fica, encargados de aplicar la bpc y velar por el cumplimiento de la misma en los ensayos cl\u00ednicos; de manera que el estudio de la forma de trabajar de los mismos permite evaluar directa el nivel de cumplimiento de la bpc en las distintas regiones.  tomando como referencia el a\u00f1o 1999, se centra el estudio en la uni\u00f3n europea, una de las tres partes firmantes de las recomendaciones ich de bpc, sometiendo a estudio a todos los ceic de tres de sus pa\u00edses integrantes (alemania, dinamarca y espa\u00f1a) mediante un estudio observacional que basa la obtenci\u00f3n de datos en un cuestionario que proporciona informaci\u00f3n acerca de la naturaleza de los ceic, su forma de trabajar y cumplimiento de bpc, balance de las actividades realizadas en un a\u00f1o y una toma de opini\u00f3n.  se obtienen 74 contes<\/p>\n<p>&nbsp;<\/p>\n<h3>Datos acad\u00e9micos de la tesis doctoral \u00ab<strong>Comit\u00e9s \u00e9ticos de investigaci\u00f3n cl\u00ednica y buena pr\u00e1ctica cl\u00ednica en europa<\/strong>\u00ab<\/h3>\n<ul>\n<li><strong>T\u00edtulo de la tesis:<\/strong>\u00a0 Comit\u00e9s \u00e9ticos de investigaci\u00f3n cl\u00ednica y buena pr\u00e1ctica cl\u00ednica en europa <\/li>\n<li><strong>Autor:<\/strong>\u00a0  Revuelta P\u00e9rez JavierAntonio <\/li>\n<li><strong>Universidad:<\/strong>\u00a0 Universitat de val\u00e9ncia (estudi general)<\/li>\n<li><strong>Fecha de lectura de la tesis:<\/strong>\u00a0 26\/07\/2002<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Direcci\u00f3n y tribunal<\/h3>\n<ul>\n<li><strong>Director de la tesis<\/strong>\n<ul>\n<li>Victor Jimenez Torres<\/li>\n<\/ul>\n<\/li>\n<li><strong>Tribunal<\/strong>\n<ul>\n<li>Presidente del tribunal: adela Mart\u00edn villodr\u00e9 <\/li>\n<li>pablo Mart\u00ednez mart\u00edn (vocal)<\/li>\n<li>\u00e1ngel Villar del fresno (vocal)<\/li>\n<li>Mar\u00eda emilia Carretero accame (vocal)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Tesis doctoral de Revuelta P\u00e9rez JavierAntonio En 1996 se afirman las recomendaciones de la conferencia internacional de armonizaci\u00f3n (ich) sobre [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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