{"id":12041,"date":"2022-02-03T13:19:09","date_gmt":"2022-02-03T12:19:09","guid":{"rendered":"https:\/\/www.idisantiago.es\/clinical-research\/"},"modified":"2024-09-19T15:40:59","modified_gmt":"2024-09-19T13:40:59","slug":"clinical-research","status":"publish","type":"page","link":"https:\/\/www.idisantiago.es\/en\/clinical-research\/","title":{"rendered":"Clinical Research"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;T\u00edtulo&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;24px||0px||false|false&#8221; custom_padding=&#8221;0px||||false|false&#8221; da_disable_devices=&#8221;off|off|off&#8221; locked=&#8221;on&#8221; collapsed=&#8221;on&#8221; global_colors_info=&#8221;{}&#8221; da_is_popup=&#8221;off&#8221; da_exit_intent=&#8221;off&#8221; da_has_close=&#8221;on&#8221; da_alt_close=&#8221;off&#8221; da_dark_close=&#8221;off&#8221; da_not_modal=&#8221;on&#8221; da_is_singular=&#8221;off&#8221; da_with_loader=&#8221;off&#8221; da_has_shadow=&#8221;on&#8221;][et_pb_row _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; width=&#8221;100%&#8221; custom_padding=&#8221;0px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_post_title meta=&#8221;off&#8221; featured_image=&#8221;off&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_post_title][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; da_disable_devices=&#8221;off|off|off&#8221; global_colors_info=&#8221;{}&#8221; da_is_popup=&#8221;off&#8221; da_exit_intent=&#8221;off&#8221; da_has_close=&#8221;on&#8221; da_alt_close=&#8221;off&#8221; da_dark_close=&#8221;off&#8221; da_not_modal=&#8221;on&#8221; da_is_singular=&#8221;off&#8221; da_with_loader=&#8221;off&#8221; da_has_shadow=&#8221;on&#8221;][et_pb_row _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/www.idisantiago.es\/wp-content\/uploads\/2022\/11\/20211116_090128-scaled.jpg&#8221; title_text=&#8221;20211116_090128&#8243; _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;|300|||||||&#8221; global_colors_info=&#8221;{}&#8221;]La investigaci\u00f3n cl\u00ednica es un apartado fundamental de la actividad investigadora de cualquier instituci\u00f3n que realice investigaci\u00f3n biom\u00e9dica y una de las principales \u00e1reas de actividad investigadora del IDIS.<\/p>\n<p>El IDIS ofrece soporte para la puesta en marcha y tramitaci\u00f3n de toda la documentaci\u00f3n necesaria para llevar a cabo estudios cl\u00ednicos comerciales e independientes.<br \/>\n[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;|300|||||||&#8221; global_colors_info=&#8221;{}&#8221;]Evoluci\u00f3n de nuevos contratos de estudios cl\u00ednicos:<\/p>\n<p>\n<div class=\"wpdt-c row wpDataTableContainerSimpleTable wpDataTables wpDataTablesWrapper\n\"\n    >\n        <table id=\"wpdtSimpleTable-1\"\n           style=\"border-collapse:collapse;\n                   border-spacing:0px;\"\n           class=\"wpdtSimpleTable wpDataTable\"\n           data-column=\"5\"\n           data-rows=\"4\"\n           data-wpID=\"1\"\n           data-responsive=\"0\"\n           data-has-header=\"1\">\n\n                    <thead>        <tr class=\"wpdt-cell-row  remove-borders \" >\n                                <th class=\"wpdt-cell  wpdt-empty-cell  remove-borders \"\n                                            data-cell-id=\"A1\"\n                    data-col-index=\"0\"\n                    data-row-index=\"0\"\n                    style=\" width:20%;                    padding:10px;\n                    \"\n                    >\n                                                            <\/th>\n                                                <th class=\"wpdt-cell wpdt-bc-10294C wpdt-tc-FFFFFF remove-borders \"\n                                            data-cell-id=\"B1\"\n                    data-col-index=\"1\"\n                    data-row-index=\"0\"\n                    style=\" width:20%;                    padding:10px;\n                    \"\n                    >\n                                        2018                    <\/th>\n                                                <th class=\"wpdt-cell wpdt-bc-10294C wpdt-tc-FFFFFF remove-borders \"\n                                            data-cell-id=\"C1\"\n                    data-col-index=\"2\"\n                    data-row-index=\"0\"\n                    style=\" width:20%;                    padding:10px;\n                    \"\n                    >\n                                        2019                    <\/th>\n                                                <th class=\"wpdt-cell wpdt-bc-10294C wpdt-tc-FFFFFF remove-borders \"\n                                            data-cell-id=\"D1\"\n                    data-col-index=\"3\"\n                    data-row-index=\"0\"\n                    style=\" width:20%;                    padding:10px;\n                    \"\n                    >\n                                        2020                    <\/th>\n                                                <th class=\"wpdt-cell wpdt-bc-10294C wpdt-tc-FFFFFF remove-borders \"\n                                            data-cell-id=\"E1\"\n                    data-col-index=\"4\"\n                    data-row-index=\"0\"\n                    style=\" width:20%;                    padding:10px;\n                    \"\n                    >\n                                        2021                    <\/th>\n                                        <\/tr>\n                    <tbody>        <tr class=\"wpdt-cell-row  remove-borders \" >\n                                <td class=\"wpdt-cell wpdt-bold remove-borders \"\n                                            data-cell-id=\"A2\"\n                    data-col-index=\"0\"\n                    data-row-index=\"1\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        Ensayos                    <\/td>\n                                                <td class=\"wpdt-cell  remove-borders \"\n                                            data-cell-id=\"B2\"\n                    data-col-index=\"1\"\n                    data-row-index=\"1\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        83                    <\/td>\n                                                <td class=\"wpdt-cell  remove-borders \"\n                                            data-cell-id=\"C2\"\n                    data-col-index=\"2\"\n                    data-row-index=\"1\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        86                    <\/td>\n                                                <td class=\"wpdt-cell  remove-borders \"\n                                            data-cell-id=\"D2\"\n                    data-col-index=\"3\"\n                    data-row-index=\"1\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        85                    <\/td>\n                                                <td class=\"wpdt-cell  remove-borders \"\n                                            data-cell-id=\"E2\"\n                    data-col-index=\"4\"\n                    data-row-index=\"1\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        115                    <\/td>\n                                        <\/tr>\n                            <tr class=\"wpdt-cell-row  remove-borders \" >\n                                <td class=\"wpdt-cell wpdt-bold remove-borders \"\n                                            data-cell-id=\"A3\"\n                    data-col-index=\"0\"\n                    data-row-index=\"2\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        Estudios                    <\/td>\n                                                <td class=\"wpdt-cell  remove-borders \"\n                                            data-cell-id=\"B3\"\n                    data-col-index=\"1\"\n                    data-row-index=\"2\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        120                    <\/td>\n                                                <td class=\"wpdt-cell  remove-borders \"\n                                            data-cell-id=\"C3\"\n                    data-col-index=\"2\"\n                    data-row-index=\"2\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        145                    <\/td>\n                                                <td class=\"wpdt-cell  remove-borders \"\n                                            data-cell-id=\"D3\"\n                    data-col-index=\"3\"\n                    data-row-index=\"2\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        171                    <\/td>\n                                                <td class=\"wpdt-cell  remove-borders \"\n                                            data-cell-id=\"E3\"\n                    data-col-index=\"4\"\n                    data-row-index=\"2\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        150                    <\/td>\n                                        <\/tr>\n                            <tr class=\"wpdt-cell-row  remove-borders \" >\n                                <td class=\"wpdt-cell wpdt-bold remove-borders \"\n                                            data-cell-id=\"A4\"\n                    data-col-index=\"0\"\n                    data-row-index=\"3\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        TOTAL                    <\/td>\n                                                <td class=\"wpdt-cell wpdt-bold remove-borders \"\n                                            data-cell-id=\"B4\"\n                    data-col-index=\"1\"\n                    data-row-index=\"3\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        203                    <\/td>\n                                                <td class=\"wpdt-cell wpdt-bold remove-borders \"\n                                            data-cell-id=\"C4\"\n                    data-col-index=\"2\"\n                    data-row-index=\"3\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        231                    <\/td>\n                                                <td class=\"wpdt-cell wpdt-bold remove-borders \"\n                                            data-cell-id=\"D4\"\n                    data-col-index=\"3\"\n                    data-row-index=\"3\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        256                    <\/td>\n                                                <td class=\"wpdt-cell wpdt-bold remove-borders \"\n                                            data-cell-id=\"E4\"\n                    data-col-index=\"4\"\n                    data-row-index=\"3\"\n                    style=\"                    padding:10px;\n                    \"\n                    >\n                                        265                    <\/td>\n                                        <\/tr>\n                    <\/table>\n<\/div><style id='wpdt-custom-style-1'>\n.wpdt-bc-10294C { background-color: #10294C !important;}\n.wpdt-tc-FFFFFF { color: #FFFFFF !important;}\n<\/style>\n<style>\n                    \n                                                \n                <\/style>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;|300|||||||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Oficina de Ensayos Cl\u00ednicos<\/h2>\n<p>La Oficina de Ensayos Cl\u00ednicos se ocupa de la tramitaci\u00f3n necesaria para iniciar estudios cl\u00ednicos en los centros de su \u00e1mbito de actuaci\u00f3n, tanto de promotores comerciales como de estudios promovidos por nuestros investigadores, entre otras tareas:<\/p>\n<ul>\n<li>Gesti\u00f3n de contratos<\/li>\n<li>Seguimiento econ\u00f3mico y facturaci\u00f3n<\/li>\n<li>Solicitudes a las Autoridades Sanitarias<\/li>\n<li>Solicitud de presupuestos a CROs y contrataci\u00f3n de seguro de responsabilidad civil<\/li>\n<\/ul>\n<p>De manera general, todos los estudios que se realicen en el \u00e1mbito de la investigaci\u00f3n biom\u00e9dica y que impliquen a seres humanos, sus muestras o sus datos de car\u00e1cter personal, deben ser sometidos a la consideraci\u00f3n de un Comit\u00e9 de \u00e9tica de la investigaci\u00f3n acreditado. El enlace para el CEIm de Galicia es el siguiente:<strong><span style=\"color: #808000;\"> <a style=\"color: #808000;\" href=\"https:\/\/acis.sergas.es\/cartafol\/Redes-de-Comites-de-Etica-da-Investigacion?idioma=es\">https:\/\/acis.sergas.es\/cartafol\/Redes-de-Comites-de-Etica-da-Investigacion?idioma=es<\/a><\/span><\/strong><\/p>\n<p>Asimismo, para iniciar cualquier estudio cl\u00ednico es necesaria la conformidad de la Gerencia del \u00c1rea Sanitaria.<\/p>\n<p>Para m\u00e1s informaci\u00f3n, contactar con el Departamento de Estudios Cl\u00ednicos de la FIDIS: <strong><span style=\"color: #808000;\"><a style=\"color: #808000;\" href=\"https:\/\/www.idisantiago.es\/estudios-clinicos\/\">https:\/\/www.idisantiago.es\/estudios-clinicos\/<\/a><\/span><\/strong><br \/>\n[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;|300|||||||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Unidad de Ensayos Cl\u00ednicos en Fases Tempranas<\/h2>\n<p>Esta Unidad est\u00e1 disponible para la realizaci\u00f3n de ensayos cl\u00ednicos de fases tempranas (I y II). Cuenta con una consulta m\u00e9dica, una sala de tratamiento con capacidad para 6 sillones reclinables, un despacho administrativo y una sala de procesamiento de muestras y almacenamiento. La Unidad ha sido recientemente certificada por la Conseller\u00eda de Sanidade. Para m\u00e1s informaci\u00f3n y condiciones de uso, pueden contactar con <span style=\"color: #808000;\"><strong><a style=\"color: #808000;\" href=\"mailto:ma.teresa.cabaleiro.ocampo@sergas.es\">ma.teresa.cabaleiro.ocampo@sergas.es<\/a>.<\/strong><\/span><br \/>\n[\/et_pb_text][et_pb_text _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;|300|||||||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Sala de Monitorizaci\u00f3n<\/h2>\n<p>Espacio reservado para las tareas de monitorizaci\u00f3n de ensayos cl\u00ednicos. Tiene capacidad para 5 puestos de trabajo, y est\u00e1 dotada de ordenadores.<br \/>\n[\/et_pb_text][et_pb_text _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;|300|||||||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Plataforma de Investigaci\u00f3n Cl\u00ednica Independiente<\/h2>\n<p>La Plataforma de Investigaci\u00f3n Cl\u00ednica Independiente del Instituto de Investigaci\u00f3n Carlos III (ISCIII) potencia el desarrollo de estudios cl\u00ednicos acad\u00e9micos, en especial aquellos financiados por el ISCIII. El contacto de la Plataforma en el IDIS es <strong><span style=\"color: #808000;\"><a style=\"color: #808000;\" href=\"mailto:plataformaici.fidis.santiago@sergas.es\">plataformaici.fidis.santiago@sergas.es<\/a>.<\/span><\/strong><br \/>\n[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.18.0&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;|300|||||||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Archivo de documentaci\u00f3n de ensayos cl\u00ednicos<\/h2>\n<p>Sala para la custodia de documentaci\u00f3n de ensayos cl\u00ednicos finalizados durante el tiempo que establece la normativa aplicable o el promotor. Se localiza en la planta -5 del Hospital Cl\u00ednico Universitario de Santiago y est\u00e1 disponible para todos aquellos Promotores que contraten este servicio.<br \/>\n[\/et_pb_text][et_pb_toggle title=&#8221;Gu\u00edas de pr\u00e1ctica cl\u00ednica&#8221; _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; width=&#8221;100%&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243; disabled_on=&#8221;on|on|on&#8221; disabled=&#8221;on&#8221;]<\/p>\n<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; da_disable_devices=&#8221;off|off|off&#8221; global_colors_info=&#8221;{}&#8221; da_is_popup=&#8221;off&#8221; da_exit_intent=&#8221;off&#8221; da_has_close=&#8221;on&#8221; da_alt_close=&#8221;off&#8221; da_dark_close=&#8221;off&#8221; da_not_modal=&#8221;on&#8221; da_is_singular=&#8221;off&#8221; da_with_loader=&#8221;off&#8221; da_has_shadow=&#8221;on&#8221;][et_pb_row _builder_version=&#8221;4.16&#8243; 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