[et_pb_section fb_built=\u00bb1″ fullwidth=\u00bbon\u00bb _builder_version=\u00bb4.27.4″ _module_preset=\u00bbdefault\u00bb background_enable_color=\u00bboff\u00bb use_background_color_gradient=\u00bbon\u00bb background_color_gradient_stops=\u00bbrgba(20,120,196,0.85) 0%|rgba(20,120,196,0.85) 100%\u00bb background_color_gradient_overlays_image=\u00bbon\u00bb background_image=\u00bbhttps:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/dna-estudos.jpg\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_fullwidth_header title=\u00bbLEGISLACI\u00d3N Y NORMAS\u00bb _builder_version=\u00bb4.27.4″ _module_preset=\u00bbdefault\u00bb title_font=\u00bb|700||on|||||\u00bb background_enable_color=\u00bboff\u00bb background_enable_image=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n
Referencias oficiales que garantizan la \u00e9tica, la seguridad y la calidad en nuestras investigaciones cl\u00ednicas<\/p>\n
[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.27.4″ _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb||30px|||\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_row column_structure=\u00bb2_3,1_3″ _builder_version=\u00bb4.27.4″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb2_3″ _builder_version=\u00bb4.27.4″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.27.4″ _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb||16px|||\u00bb hover_enabled=\u00bb0″ global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb sticky_enabled=\u00bb0″]<\/p>\n
La investigaci\u00f3n cl\u00ednica est\u00e1 guiada por normas \u00e9ticas y legales que aseguran la protecci\u00f3n de los participantes, la validez cient\u00edfica de los estudios y la responsabilidad de las instituciones involucradas.<\/p>\n
En esta secci\u00f3n, reunimos los principales marcos regulatorios que orientan la actuaci\u00f3n del NPCRS, garantizando rigor cient\u00edfico, respeto a la dignidad humana y conformidad con las mejores pr\u00e1cticas internacionales.<\/p>\n
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<\/i> Co\u0301digo de Nu\u0308remberg \u2013 1947<\/a><\/p>\n <\/i> Declara\u00e7\u00e3o de Helsinque 2013<\/a><\/p>\n <\/i> Boas Pr\u00e1ticas Cl\u00ednicas: Documento das Am\u00e9ricas de 2005<\/a><\/p>\n <\/i> Instru\u00e7\u00e3o Normativa n\u00b04 de 2009 Anvisa<\/a><\/p>\n <\/i> Normativa n\u00b021 de 02 de Outubro de 2017<\/a><\/p>\n <\/i> Normativa n\u00b0190 de 03 de Outubro de 2017<\/a><\/p>\n <\/i> Normativa n\u00b020 de 2017 de Medicamentos Anvisa.pdf<\/a><\/p>\n <\/i> Resolu\u00e7\u00e3o da Diretoria Colegiada \u2013 RDC n\u00b010 de 20 de fevereiro de 2015<\/a><\/p>\n <\/i> Resolu\u00e7\u00e3o n\u00b0466 de 12 de dezembro de 2012<\/a><\/p>\n <\/i> Good Practice clinical \u2013 R2_Adendo_Ingl\u00eas_2016<\/a><\/p>\n <\/i> RESOLU\u00c7\u00c3O N\u00ba 510, DE 07 DE ABRIL DE 2016<\/a><\/p>\n