{"id":3435,"date":"2024-08-12T15:10:10","date_gmt":"2024-08-12T15:10:10","guid":{"rendered":"https:\/\/cymresearchsa.com\/?page_id=3435"},"modified":"2025-04-07T23:40:40","modified_gmt":"2025-04-07T23:40:40","slug":"requisitos-para-sometimiento-de-protocolos","status":"publish","type":"page","link":"https:\/\/cymresearchsa.com\/en\/requisitos-para-sometimiento-de-protocolos\/","title":{"rendered":"Requirements for some protocol compliance"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_section full_width=&#8221;stretch_row_content&#8221; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;][vc_row full_width=&#8221;stretch_row_content_no_spaces&#8221; el_class=&#8221;content-img-header_page&#8221; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;][vc_column][vc_single_image image=&#8221;3273&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; css=&#8221;.vc_custom_1723475405494{margin-bottom: 0px !important;}&#8221; el_class=&#8221;img-header_page&#8221;][vc_row_inner wrap_container=&#8221;yes&#8221; el_class=&#8221;box_textos-header_page&#8221;][vc_column_inner]<div class=\"porto-u-heading content-text-header_page  wpb_custom_95aa9a11c17ad45cfabaf210d84ee7cc porto-u-8341\"><div class=\"porto-u-main-heading\"><h1   style=\"color:#ffffff;\">Requirements for some protocol compliance<\/h1><\/div><style>.porto-u-8341.porto-u-heading{text-align:left}<\/style><\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][\/vc_section][vc_section conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221; css=&#8221;.vc_custom_1720028941298{padding-top: 0px !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221; el_class=&#8221;fondo_gradien-investigacion&#8221;][vc_row wrap_container=&#8221;yes&#8221; css=&#8221;.vc_custom_1723473465564{padding-top: 50px !important;padding-bottom: 35px !important;}&#8221; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;][vc_column]<div class=\"porto-u-heading titulo-line_page  wpb_custom_320ff9a05248e122a0ff5015c10bd3f9 porto-u-1611\"><div class=\"porto-u-main-heading\"><h1   style=\"color:#ffffff;margin-bottom: 15px;\">Requirements for submission to the MINSA\/RESEGIS<\/h1><\/div><style>.porto-u-1611.porto-u-heading{text-align:center}<\/style><\/div>[\/vc_column][\/vc_row][\/vc_section][vc_section css=&#8221;.vc_custom_1723475185874{margin-bottom: 15px !important;}&#8221; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;][vc_row full_width=&#8221;stretch_row_content_no_spaces&#8221; wrap_container=&#8221;yes&#8221; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221; el_class=&#8221;content-box-compromisos&#8221;][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-4 vc_col-xs-6&#8243; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;]<div class=\"porto-sicon-box box-compromisos  wpb_custom_d0a1327324769d2c03e290d430ad2764 style_1 top-icon\"><div class=\"porto-sicon-top\"><div class=\"porto-just-icon-wrapper porto-icon advanced\" style=\"color:#172a7b;width:70px;height:70px;line-height:70px;border-radius:500px;font-size:32px;\"><i class=\"Simple-Line-Icons-layers\"><\/i><\/div><\/div><div class=\"porto-sicon-header\"><h3 class=\"porto-sicon-title\" style=\"\">Protocol<\/h3><\/div> <!-- header --><\/div><!-- porto-sicon-box -->[\/vc_column][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-4 vc_col-xs-6&#8243; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;]<div class=\"porto-sicon-box box-compromisos  wpb_custom_d0a1327324769d2c03e290d430ad2764 style_1 top-icon\"><div class=\"porto-sicon-top\"><div class=\"porto-just-icon-wrapper porto-icon advanced\" style=\"color:#172a7b;width:70px;height:70px;line-height:70px;border-radius:500px;font-size:32px;\"><i class=\"Simple-Line-Icons-user-following\"><\/i><\/div><\/div><div class=\"porto-sicon-header\"><h3 class=\"porto-sicon-title\" style=\"\">Informed Consent<\/h3><\/div> <!-- header --><\/div><!-- porto-sicon-box -->[\/vc_column][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-4 vc_col-xs-6&#8243; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;]<div class=\"porto-sicon-box box-compromisos  wpb_custom_d0a1327324769d2c03e290d430ad2764 style_1 top-icon\"><div class=\"porto-sicon-top\"><div class=\"porto-just-icon-wrapper porto-icon advanced\" style=\"color:#172a7b;width:70px;height:70px;line-height:70px;border-radius:500px;font-size:32px;\"><i class=\"Simple-Line-Icons-note\"><\/i><\/div><\/div><div class=\"porto-sicon-header\"><h3 class=\"porto-sicon-title\" style=\"\">No objection letter from research site<\/h3><\/div> <!-- header --><\/div><!-- porto-sicon-box -->[\/vc_column][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-4 vc_col-xs-6&#8243; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;]<div class=\"porto-sicon-box box-compromisos  wpb_custom_d0a1327324769d2c03e290d430ad2764 style_1 top-icon\"><div class=\"porto-sicon-top\"><div class=\"porto-just-icon-wrapper porto-icon advanced\" style=\"color:#172a7b;width:70px;height:70px;line-height:70px;border-radius:500px;font-size:32px;\"><i class=\"Simple-Line-Icons-envelope-letter\"><\/i><\/div><\/div><div class=\"porto-sicon-header\"><h3 class=\"porto-sicon-title\" style=\"\">Sponsorship commitment letter<\/h3><\/div> <!-- header --><\/div><!-- porto-sicon-box -->[\/vc_column][vc_column width=&#8221;1\/2&#8243; offset=&#8221;vc_col-md-4 vc_col-xs-6&#8243; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;]<div class=\"porto-sicon-box box-compromisos  wpb_custom_d0a1327324769d2c03e290d430ad2764 style_1 top-icon\"><div class=\"porto-sicon-top\"><div class=\"porto-just-icon-wrapper porto-icon advanced\" style=\"color:#172a7b;width:70px;height:70px;line-height:70px;border-radius:500px;font-size:32px;\"><i class=\"Simple-Line-Icons-doc\"><\/i><\/div><\/div><div class=\"porto-sicon-header\"><h3 class=\"porto-sicon-title\" style=\"\">Certificate of good manufacturing practices for the device or related<\/h3><\/div> <!-- header --><\/div><!-- porto-sicon-box -->[\/vc_column][\/vc_row][\/vc_section][vc_section conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221; css=&#8221;.vc_custom_1720028941298{padding-top: 0px !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221; el_class=&#8221;fondo_gradien-investigacion&#8221;][vc_row wrap_container=&#8221;yes&#8221; css=&#8221;.vc_custom_1723473465564{padding-top: 50px !important;padding-bottom: 35px !important;}&#8221; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;][vc_column]<div class=\"porto-u-heading titulo-line_page  wpb_custom_320ff9a05248e122a0ff5015c10bd3f9 porto-u-3089\"><div class=\"porto-u-main-heading\"><h1   style=\"color:#ffffff;margin-bottom: 15px;\">Requirements for submission to the Ethics Committee<\/h1><\/div><style>.porto-u-3089.porto-u-heading{text-align:center}<\/style><\/div>[\/vc_column][\/vc_row][\/vc_section][vc_section css=&#8221;.vc_custom_1723475174038{margin-bottom: 15px !important;}&#8221; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;][vc_row full_width=&#8221;stretch_row_content_no_spaces&#8221; wrap_container=&#8221;yes&#8221; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221; el_class=&#8221;content-box-compromisos&#8221;][vc_column width=&#8221;1\/3&#8243; offset=&#8221;vc_col-md-3 vc_col-xs-6&#8243; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;]<div class=\"porto-sicon-box box-compromisos  wpb_custom_d0a1327324769d2c03e290d430ad2764 style_1 top-icon\"><div class=\"porto-sicon-top\"><div class=\"porto-just-icon-wrapper porto-icon advanced\" style=\"color:#172a7b;width:70px;height:70px;line-height:70px;border-radius:500px;font-size:32px;\"><i class=\"Simple-Line-Icons-refresh\"><\/i><\/div><\/div><div class=\"porto-sicon-header\"><h3 class=\"porto-sicon-title\" style=\"\">Protocolo en espa\u00f1ol e ingl\u00e9s<\/h3><\/div> <!-- header --><\/div><!-- porto-sicon-box -->[\/vc_column][vc_column width=&#8221;1\/3&#8243; offset=&#8221;vc_col-md-3 vc_col-xs-6&#8243; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;]<div class=\"porto-sicon-box box-compromisos  wpb_custom_d0a1327324769d2c03e290d430ad2764 style_1 top-icon\"><div class=\"porto-sicon-top\"><div class=\"porto-just-icon-wrapper porto-icon advanced\" style=\"color:#172a7b;width:70px;height:70px;line-height:70px;border-radius:500px;font-size:32px;\"><i class=\"Simple-Line-Icons-logout\"><\/i><\/div><\/div><div class=\"porto-sicon-header\"><h3 class=\"porto-sicon-title\" style=\"\">Informed consent<\/h3><\/div> <!-- header --><\/div><!-- porto-sicon-box -->[\/vc_column][vc_column width=&#8221;1\/3&#8243; offset=&#8221;vc_col-md-3 vc_col-xs-6&#8243; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;]<div class=\"porto-sicon-box box-compromisos  wpb_custom_d0a1327324769d2c03e290d430ad2764 style_1 top-icon\"><div class=\"porto-sicon-top\"><div class=\"porto-just-icon-wrapper porto-icon advanced\" style=\"color:#172a7b;width:70px;height:70px;line-height:70px;border-radius:500px;font-size:32px;\"><i class=\"Simple-Line-Icons-book-open\"><\/i><\/div><\/div><div class=\"porto-sicon-header\"><h3 class=\"porto-sicon-title\" style=\"\">Spanish and English researcher's manual<\/h3><\/div> <!-- header --><\/div><!-- porto-sicon-box -->[\/vc_column][vc_column width=&#8221;1\/3&#8243; offset=&#8221;vc_col-md-3 vc_col-xs-6&#8243; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;]<div class=\"porto-sicon-box box-compromisos  wpb_custom_d0a1327324769d2c03e290d430ad2764 style_1 top-icon\"><div class=\"porto-sicon-top\"><div class=\"porto-just-icon-wrapper porto-icon advanced\" style=\"color:#172a7b;width:70px;height:70px;line-height:70px;border-radius:500px;font-size:32px;\"><i class=\"Simple-Line-Icons-notebook\"><\/i><\/div><\/div><div class=\"porto-sicon-header\"><h3 class=\"porto-sicon-title\" style=\"\">Instructions for Use in Spanish and English<\/h3><\/div> <!-- header --><\/div><!-- porto-sicon-box -->[\/vc_column][vc_column width=&#8221;1\/3&#8243; offset=&#8221;vc_col-md-3 vc_col-xs-6&#8243; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;]<div class=\"porto-sicon-box box-compromisos  wpb_custom_d0a1327324769d2c03e290d430ad2764 style_1 top-icon\"><div class=\"porto-sicon-top\"><div class=\"porto-just-icon-wrapper porto-icon advanced\" style=\"color:#172a7b;width:70px;height:70px;line-height:70px;border-radius:500px;font-size:32px;\"><i class=\"Simple-Line-Icons-pencil\"><\/i><\/div><\/div><div class=\"porto-sicon-header\"><h3 class=\"porto-sicon-title\" style=\"\">Questionnaires for subjects if applicable<\/h3><\/div> <!-- header --><\/div><!-- porto-sicon-box -->[\/vc_column][vc_column width=&#8221;1\/3&#8243; offset=&#8221;vc_col-md-3 vc_col-xs-6&#8243; conditional_render=&#8221;%5B%7B%22value_role%22%3A%22administrator%22%7D%5D&#8221;]<div class=\"porto-sicon-box box-compromisos  wpb_custom_d0a1327324769d2c03e290d430ad2764 style_1 top-icon\"><div class=\"porto-sicon-top\"><div class=\"porto-just-icon-wrapper porto-icon advanced\" style=\"color:#172a7b;width:70px;height:70px;line-height:70px;border-radius:500px;font-size:32px;\"><i class=\"Simple-Line-Icons-badge\"><\/i><\/div><\/div><div class=\"porto-sicon-header\"><h3 class=\"porto-sicon-title\" style=\"\">Translation certificate of all documents<\/h3><\/div> <!-- header --><\/div><!-- porto-sicon-box -->[\/vc_column][vc_column width=&#8221;1\/3&#8243; 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