{"id":6683,"date":"2024-10-17T11:44:27","date_gmt":"2024-10-17T11:44:27","guid":{"rendered":"https:\/\/ibsal.es\/ceim\/"},"modified":"2025-03-12T10:43:58","modified_gmt":"2025-03-12T10:43:58","slug":"ceim","status":"publish","type":"page","link":"https:\/\/ibsal.es\/en\/ceim\/","title":{"rendered":"CEIm"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6683\" class=\"elementor elementor-6683 elementor-2532\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7780555 e-flex e-con-boxed e-con e-parent\" data-id=\"7780555\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-29a81f0 e-con-full e-flex e-con e-child\" data-id=\"29a81f0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6639e67 elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"6639e67\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">CEIm<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6a52c84 elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"6a52c84\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The Ethics Committee for Research with Medicines (CEIm) of the Salamanca Health Area is responsible for evaluating and supervising clinical trials, observational studies and other biomedical research studies in primary care and specialized care, all from the Complejo Asistencial Universitario de Salamanca. At IBSAL, these functions are applied to human studies. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b363683 e-flex e-con-boxed e-con e-parent\" data-id=\"b363683\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f5e4eb3 e-con-full e-flex e-con e-child\" data-id=\"f5e4eb3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-880c359 elementor-widget-tablet__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"880c359\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is its function?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d143895 elementor-widget-mobile__width-initial elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"d143895\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7808484 elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"7808484\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The main function of the IRB\/IEC is to report on the ethical, methodological and legal suitability of a biomedical study. This assessment is carried out before the start of the study, in order to approve its start-up, and throughout the course of the study. <\/p><p>This <a href=\"https:\/\/ibsal.es\/en\/organization-chart\/#comite-etico\">committee<\/a> was accredited as CEIm by the Junta de Castilla y Le\u00f3n on January 29, 2018, in accordance with the &#8220;Real Decreto 1090\/2015, de 4 de diciembre, por el que se regulan los ensayos cl\u00ednicos con medicamentos, los Comit\u00e9s de \u00c9tica de la Investigaci\u00f3n con medicamentos y el Registro Espa\u00f1ol de Estudios Cl\u00ednicos&#8221; (Royal Decree 1090\/2015, of December 4, regulating clinical trials with medicinal products, the Ethics Committees for Research with medicinal products and the Spanish Registry of Clinical Studies). Its latest reaccreditation was approved on April 18, 2024. <\/p><p>In addition, it is a member of the Memorandum of Collaboration and Information Exchange between the Spanish Agency of Medicines and Health Products and the Ethics Committees for Research with Medicines.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6c45c45 elementor-widget-mobile__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"6c45c45\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/drive.google.com\/uc?export=download&#038;id=1LwSf-9BOfPFPs5CgH5mijWC74hfRl7AW\" target=\"_blank\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 10L12 16L18 10\" stroke=\"#003C8C\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><path d=\"M12 4V16\" stroke=\"#003C8C\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><path d=\"M6 20H18\" stroke=\"#DA251D\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">CEIm 2024.rar models<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/drive.google.com\/uc?export=download&#038;id=1hL5lcQYq32x5wdXkpkfs-jbWnCk5CUcz\" target=\"_blank\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 10L12 16L18 10\" stroke=\"#003C8C\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><path d=\"M12 4V16\" stroke=\"#003C8C\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><path d=\"M6 20H18\" stroke=\"#DA251D\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">CEIm 2024 Requirements.rar<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/ibsal.es\/wp-content\/uploads\/2024\/10\/Guia-CEIm-HIP-y-CI-vOct-2023.docx\" target=\"_blank\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 10L12 16L18 10\" stroke=\"#003C8C\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><path d=\"M12 4V16\" stroke=\"#003C8C\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><path d=\"M6 20H18\" stroke=\"#DA251D\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">CEIm HIP and CI 2023 Guide.docx<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6459459 e-con-full e-flex e-con e-child\" data-id=\"6459459\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-816a593 elementor-widget-mobile__width-initial elementor-widget elementor-widget-image\" data-id=\"816a593\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"438\" height=\"357\" src=\"https:\/\/ibsal.es\/wp-content\/uploads\/2025\/01\/ceim-pic1-ibsal.png\" class=\"attachment-full size-full wp-image-6389\" alt=\"\" srcset=\"https:\/\/ibsal.es\/wp-content\/uploads\/2025\/01\/ceim-pic1-ibsal.png 438w, https:\/\/ibsal.es\/wp-content\/uploads\/2025\/01\/ceim-pic1-ibsal-300x245.png 300w\" sizes=\"(max-width: 438px) 100vw, 438px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8abd572 e-flex e-con-boxed e-con e-parent\" data-id=\"8abd572\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-31f997b elementor-widget-tablet__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"31f997b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is the procedure to be followed according to the study?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-86d2401 elementor-widget-mobile__width-initial elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"86d2401\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b7f68ad elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-image\" data-id=\"b7f68ad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/ibsal.es\/wp-content\/uploads\/2024\/10\/Diagrama-CEIm-1.png\" data-elementor-open-lightbox=\"yes\" data-elementor-lightbox-title=\"Diagrama CEIm (1)\" data-e-action-hash=\"#elementor-action%3Aaction%3Dlightbox%26settings%3DeyJpZCI6NjEzMywidXJsIjoiaHR0cHM6XC9cL2lic2FsLmVzXC93cC1jb250ZW50XC91cGxvYWRzXC8yMDI0XC8xMFwvRGlhZ3JhbWEtQ0VJbS0xLnBuZyJ9\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2800\" height=\"1500\" src=\"https:\/\/ibsal.es\/wp-content\/uploads\/2024\/10\/Diagrama-CEIm-1.png\" class=\"attachment-full size-full wp-image-6133\" alt=\"\" srcset=\"https:\/\/ibsal.es\/wp-content\/uploads\/2024\/10\/Diagrama-CEIm-1.png 2800w, https:\/\/ibsal.es\/wp-content\/uploads\/2024\/10\/Diagrama-CEIm-1-300x161.png 300w, https:\/\/ibsal.es\/wp-content\/uploads\/2024\/10\/Diagrama-CEIm-1-1024x549.png 1024w, https:\/\/ibsal.es\/wp-content\/uploads\/2024\/10\/Diagrama-CEIm-1-768x411.png 768w, https:\/\/ibsal.es\/wp-content\/uploads\/2024\/10\/Diagrama-CEIm-1-1536x823.png 1536w, https:\/\/ibsal.es\/wp-content\/uploads\/2024\/10\/Diagrama-CEIm-1-2048x1097.png 2048w\" sizes=\"(max-width: 2800px) 100vw, 2800px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a3d8ae4 e-flex e-con-boxed e-con e-parent\" data-id=\"a3d8ae4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-aec975f elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"aec975f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Frequently Asked Questions<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b8f004 elementor-widget-mobile__width-initial elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"2b8f004\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5c61e42 elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-n-accordion\" data-id=\"5c61e42\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9680\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-9680\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> When should I submit a study? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-9680\" class=\"elementor-element elementor-element-7badc54 e-con-full e-flex e-con e-child\" data-id=\"7badc54\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fbeed4d elementor-widget elementor-widget-text-editor\" data-id=\"fbeed4d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Research projects must be submitted to the CEIm for evaluation before <\/span><b>before <\/b> <span style=\"font-weight: 400;\">of its realization. A research project cannot be initiated without the corresponding favorable opinion of the CEIm. <\/span><\/p><p><span style=\"font-weight: 400;\">CEIm will not evaluate projects that have already been carried out.  <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9681\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9681\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> When should I submit a study? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-9681\" class=\"elementor-element elementor-element-2c4ef72 e-con-full e-flex e-con e-child\" data-id=\"2c4ef72\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cfb3685 elementor-widget elementor-widget-text-editor\" data-id=\"cfb3685\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Organic Law 15\/1999, of December 13, 1999, on the Protection of Personal Data has been repealed as of December 7, 2018. The law currently in force is Organic Law 3\/2018, of December 5. <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9682\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9682\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How should I submit documentation or notifications to CEIm? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-9682\" class=\"elementor-element elementor-element-a2ef315 e-con-full e-flex e-con e-child\" data-id=\"a2ef315\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f628902 elementor-widget elementor-widget-text-editor\" data-id=\"f628902\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">All notifications and documents must be sent in digital format only. <\/span><b>exclusively in digital format<\/b><span style=\"font-weight: 400;\"> (Article 14.3 of Law 39\/2015 of October 1) by email to the committee&#8217;s address<a href=\"mailto:comit%C3%A9.etico.husa@saludcastillayleon.es\">(comit\u00e9.etico.husa@saludcastillayleon.es)<\/a> or to Clinical Trials with Medicinal Products, through the European Clinical Trials platform (CTIS).<\/span><\/p><p><span style=\"font-weight: 400;\">No paper documentation will be accepted (Act 2021\/04).<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9683\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9683\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What documentation do I need to submit for my study? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-9683\" class=\"elementor-element elementor-element-1b8c289 e-con-full e-flex e-con e-child\" data-id=\"1b8c289\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b86b30f elementor-widget elementor-widget-text-editor\" data-id=\"b86b30f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">In the requirements section of this page <\/span><span style=\"font-weight: 400;\">you can find the documents to be submitted according to the type of study (see diagram above).<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9684\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9684\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Is it necessary to add in the HIP the contact for the local IP? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-9684\" class=\"elementor-element elementor-element-e68d122 e-con-full e-flex e-con e-child\" data-id=\"e68d122\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8a7324c elementor-widget elementor-widget-text-editor\" data-id=\"8a7324c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The participant information sheet (HIP) should include the principal investigator&#8217;s contact information (name and telephone number) so that he\/she can be contacted in case of questions.<\/span><\/p><p><span style=\"font-weight: 400;\">In multicenter studies (or with a view to becoming so), it is ideal to leave a space for the center, the principal investigator and the corresponding contact telephone number to be added.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9685\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"6\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9685\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> With whom should I manage the contract for a clinical research study? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-9685\" class=\"elementor-element elementor-element-8c1ccab e-con-full e-flex e-con e-child\" data-id=\"8c1ccab\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3080704 elementor-widget elementor-widget-text-editor\" data-id=\"3080704\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">To carry out the study in our Health Area you need to contact the legal services of the University Hospital of Salamanca<a href=\"mailto:juridica.husa@saludcastillayleon.es\">(juridica.husa@saludcastillayleon.es)<\/a> and the Biomedical Research Institute of Salamanca (<a href=\"mailto:ensayosclinicos@ibsal.es\">ensayosclinicos@ibsal.es)<\/a> to specify the legal and contractual aspects.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9686\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"7\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9686\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How do I know the classification of my study and the administrative route to follow? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-9686\" class=\"elementor-element elementor-element-2b126d6 e-con-full e-flex e-con e-child\" data-id=\"2b126d6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3a4cbf6 elementor-widget elementor-widget-text-editor\" data-id=\"3a4cbf6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The decision tree in the previous section can help you follow the appropriate administrative path.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9687\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"8\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9687\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How are the fees for the evaluation of studies processed? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-9687\" class=\"elementor-element elementor-element-6948061 e-con-full e-flex e-con e-child\" data-id=\"6948061\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-14efabc elementor-widget elementor-widget-text-editor\" data-id=\"14efabc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">For initial clinical trial evaluation submissions with drug as the reference IRB, the fee is unique for the agency and the committee. The payment of fees will be processed through this   <\/span><a href=\"https:\/\/ecmi.aemps.es\/ecmi\/faces\/tasas\/gestion\/formulario.xhtml\"><span style=\"font-weight: 400;\">form<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p><p><span style=\"font-weight: 400;\">The payment of fees for the evaluation of observational studies with drugs or clinical research with medical devices is done through form 046, for more information click on the following links:<\/span><\/p><ul><li><a href=\"https:\/\/tributos.jcyl.es\/web\/jcyl\/Tributos\/es\/Plantilla100\/1284270178029\/_\/_\/_\"><span style=\"font-weight: 400;\"> \nhttps:\/\/tributos.jcyl.es\/web\/jcyl\/Tributos\/es\/Plantilla100\/1284270178029\/_\/_\/_<\/span><\/a><\/li><li><a href=\"https:\/\/tributos.jcyl.es\/web\/jcyl\/Tributos\/es\/Plantilla100\/1284270176021\/_\/_\/_\"><span style=\"font-weight: 400;\"> \nhttps:\/\/tributos.jcyl.es\/web\/jcyl\/Tributos\/es\/Plantilla100\/1284270176021\/_\/_\/_<\/span><\/a><\/li><\/ul><p> <\/p><p><span style=\"font-weight: 400;\">The rate has an identification code:<\/span><\/p><p><span style=\"font-weight: 400;\">HEALTH, D.G. Public Health, 306.1.0 Fee for sanitary services:<\/span><\/p><p><span style=\"font-weight: 400;\">306.1.0.9: Biomedical and Health Sciences Research: For the processing and management of actions prior to the issuance of opinions by the Clinical Research Ethics Committee regarding the performance of clinical trials and post-authorization studies with drugs for human use or medical devices.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9688\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"9\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9688\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Do we accept opinions from another reference IRB\/IEC? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-9688\" class=\"elementor-element elementor-element-bf2e32a e-con-full e-flex e-con e-child\" data-id=\"bf2e32a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0a7e80e elementor-widget elementor-widget-text-editor\" data-id=\"0a7e80e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">For clinical drug trials:<\/span><\/p><p><span style=\"font-weight: 400;\">&#8211; A clinical trial with medicinal product that has the favorable opinion of another reference CEIm would be under the protection of Article 17.2.a of Royal Decree 1090\/2015 of December 4, which indicates that the opinion issued by a CEIm of national territory will be unique and binding, therefore, its evaluation by the Ethics Committee of the Salamanca Health Area is not necessary.<\/span><\/p><p><span style=\"font-weight: 400;\">For observational studies:<\/span><\/p><p><span style=\"font-weight: 400;\">&#8211; An observational study with a drug that has a favorable opinion from another reference IRB would be covered by article 4.1 of R.D. 957\/2020 of November 3, which indicates that the opinion issued by an IRB in the national territory will be unique and binding; therefore, its evaluation by the Ethics Committee of the Salamanca Health Area is not necessary.<\/span><\/p><p><span style=\"font-weight: 400;\">For clinical research with medical devices:<\/span><\/p><p><span style=\"font-weight: 400;\">&#8211; A clinical research study with a medical device that has the favorable opinion of another reference CEIm would be covered by article 30.3 of Royal Decree 192\/2023 of March 21, which indicates that the opinion issued by a CEIm of national territory will be unique and binding, therefore, it is not necessary for it to be evaluated by the Ethics Committee of the Salamanca Health Area.<\/span><\/p><p><span style=\"font-weight: 400;\">For research projects:<\/span><\/p><p><span style=\"font-weight: 400;\">&#8211; For research projects with a favorable opinion from another reference CEIm, local aspects will be evaluated to report on the feasibility of carrying out the study in our health area.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"When should I submit a study?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Organic Law 15\\\/1999, of December 13, 1999, on the Protection of Personal Data has been repealed as of December 7, 2018. The law currently in force is Organic Law 3\\\/2018, of December 5.\"}},{\"@type\":\"Question\",\"name\":\"How should I submit documentation or notifications to CEIm?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"All notifications and documents must be sent in digital format only. exclusively in digital format (Article 14.3 of Law 39\\\/2015 of October 1) by email to the committee&#8217;s address(comit\\u00e9.etico.husa@saludcastillayleon.es) or to Clinical Trials with Medicinal Products, through the European Clinical Trials platform (CTIS).No paper documentation will be accepted (Act 2021\\\/04).\"}},{\"@type\":\"Question\",\"name\":\"What documentation do I need to submit for my study?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"In the requirements section of this page you can find the documents to be submitted according to the type of study (see diagram above).\"}},{\"@type\":\"Question\",\"name\":\"Is it necessary to add in the HIP the contact for the local IP?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The participant information sheet (HIP) should include the principal investigator&#8217;s contact information (name and telephone number) so that he\\\/she can be contacted in case of questions.In multicenter studies (or with a view to becoming so), it is ideal to leave a space for the center, the principal investigator and the corresponding contact telephone number to be added.\"}},{\"@type\":\"Question\",\"name\":\"With whom should I manage the contract for a clinical research study?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"To carry out the study in our Health Area you need to contact the legal services of the University Hospital of Salamanca(juridica.husa@saludcastillayleon.es) and the Biomedical Research Institute of Salamanca (ensayosclinicos@ibsal.es) to specify the legal and contractual aspects.\"}},{\"@type\":\"Question\",\"name\":\"How do I know the classification of my study and the administrative route to follow?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The decision tree in the previous section can help you follow the appropriate administrative path.\"}},{\"@type\":\"Question\",\"name\":\"How are the fees for the evaluation of studies processed?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"For initial clinical trial evaluation submissions with drug as the reference IRB, the fee is unique for the agency and the committee. The payment of fees will be processed through this   form.The payment of fees for the evaluation of observational studies with drugs or clinical research with medical devices is done through form 046, for more information click on the following links: \\nhttps:\\\/\\\/tributos.jcyl.es\\\/web\\\/jcyl\\\/Tributos\\\/es\\\/Plantilla100\\\/1284270178029\\\/_\\\/_\\\/_ \\nhttps:\\\/\\\/tributos.jcyl.es\\\/web\\\/jcyl\\\/Tributos\\\/es\\\/Plantilla100\\\/1284270176021\\\/_\\\/_\\\/_ The rate has an identification code:HEALTH, D.G. Public Health, 306.1.0 Fee for sanitary services:306.1.0.9: Biomedical and Health Sciences Research: For the processing and management of actions prior to the issuance of opinions by the Clinical Research Ethics Committee regarding the performance of clinical trials and post-authorization studies with drugs for human use or medical devices.\"}},{\"@type\":\"Question\",\"name\":\"Do we accept opinions from another reference IRB\\\/IEC?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"For clinical drug trials:&#8211; A clinical trial with medicinal product that has the favorable opinion of another reference CEIm would be under the protection of Article 17.2.a of Royal Decree 1090\\\/2015 of December 4, which indicates that the opinion issued by a CEIm of national territory will be unique and binding, therefore, its evaluation by the Ethics Committee of the Salamanca Health Area is not necessary.For observational studies:&#8211; An observational study with a drug that has a favorable opinion from another reference IRB would be covered by article 4.1 of R.D. 957\\\/2020 of November 3, which indicates that the opinion issued by an IRB in the national territory will be unique and binding; therefore, its evaluation by the Ethics Committee of the Salamanca Health Area is not necessary.For clinical research with medical devices:&#8211; A clinical research study with a medical device that has the favorable opinion of another reference CEIm would be covered by article 30.3 of Royal Decree 192\\\/2023 of March 21, which indicates that the opinion issued by a CEIm of national territory will be unique and binding, therefore, it is not necessary for it to be evaluated by the Ethics Committee of the Salamanca Health Area.For research projects:&#8211; For research projects with a favorable opinion from another reference CEIm, local aspects will be evaluated to report on the feasibility of carrying out the study in our health 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[&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"footnotes":""},"class_list":["post-6683","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.12 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>CEIm | 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