{"id":6878,"date":"2020-02-07T13:14:07","date_gmt":"2020-02-07T13:14:07","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6878"},"modified":"2021-04-06T12:36:40","modified_gmt":"2021-04-06T12:36:40","slug":"writing-a-clinical-evaluation-report-5-quick-tips","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/pt\/writing-a-clinical-evaluation-report-5-quick-tips\/","title":{"rendered":"Escrever um Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica: 5 Dicas r\u00e1pidas"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Tabela de Conte\u00fados<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f2c6fb008ff\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f2c6fb008ff\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/writing-a-clinical-evaluation-report-5-quick-tips\/#1_Define_a_CER_protocol_and_strategy\" title=\"1. Definir um protocolo e estrat\u00e9gia de CER\">1. Definir um protocolo e estrat\u00e9gia de CER<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/writing-a-clinical-evaluation-report-5-quick-tips\/#2_Demonstrate_equivalence\" title=\"2. Demonstrar equival\u00eancia\">2. Demonstrar equival\u00eancia<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/writing-a-clinical-evaluation-report-5-quick-tips\/#3_Evaluate_literature_review_data\" title=\"3. Avalie os dados de revis\u00e3o de literatura\">3. Avalie os dados de revis\u00e3o de literatura<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/writing-a-clinical-evaluation-report-5-quick-tips\/#4_Determine_requirement_for_clinical_investigation\" title=\"4. Determinar a necessidade de investiga\u00e7\u00e3o cl\u00ednica\">4. Determinar a necessidade de investiga\u00e7\u00e3o cl\u00ednica<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/writing-a-clinical-evaluation-report-5-quick-tips\/#5_Monitor_post-market_activities\" title=\"5. Monitorar as atividades p\u00f3s-mercado\">5. Monitorar as atividades p\u00f3s-mercado<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Sophie Laurenson, <a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">sa\u00fade<\/a> &amp; technology innovator\u00a0on Kolabtree, shares 5 tips for writing a clinical evaluation report and defining a CER strategy.<\/em><\/p>\n<p>O MDR da UE teve um impacto significativo na forma como os dispositivos m\u00e9dicos s\u00e3o regulados na Europa. Como parte da conformidade regulamentar, os fabricantes de produtos m\u00e9dicos precisam criar e manter um Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica (CER), um documento essencial para a Marca\u00e7\u00e3o CE. Aqui est\u00e3o dicas de especialistas sobre o que levar em considera\u00e7\u00e3o para definir uma estrat\u00e9gia de CER robusta.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Define_a_CER_protocol_and_strategy\"><\/span>1. Definir um protocolo e estrat\u00e9gia de CER<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Identificar os Requisitos Essenciais (Requisitos de Seguran\u00e7a e Desempenho no MDR) que precisam ser apoiados por evid\u00eancias cl\u00ednicas. Definir m\u00e9tricas relativas ao desempenho, seguran\u00e7a e pontos finais de risco\/benef\u00edcio.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Demonstrate_equivalence\"><\/span><strong>2. Demonstrar equival\u00eancia<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>A equival\u00eancia \u00e9 determinada com base na compara\u00e7\u00e3o entre um dispositivo m\u00e9dico e outros dispositivos pr\u00e9-existentes e similares com a marca CE. A demonstra\u00e7\u00e3o da equival\u00eancia \u00e9 avaliada em par\u00e2metros relevantes que s\u00e3o definidos pelo fabricante. A fundamenta\u00e7\u00e3o da equival\u00eancia deve ser totalmente explicada no CER. Os crit\u00e9rios de equival\u00eancia se tornaram complexos e rigorosos, com conex\u00f5es mais fortes com os Requisitos Essenciais. \u00c9 fundamental evitar o erro comum de selecionar dispositivos equivalentes que n\u00e3o s\u00e3o relevantes ao seu produto. Os dados documentados devem ser identificados e analisados para cada dispositivo equivalente e para as diferen\u00e7as entre os dispositivos.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Evaluate_literature_review_data\"><\/span><strong>3. Avalie os dados de revis\u00e3o de literatura<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">Se a equival\u00eancia puder ser demonstrada adequadamente, os dados cl\u00ednicos extra\u00eddos da literatura sobre estudos anteriores s\u00e3o uma ferramenta valiosa na compila\u00e7\u00e3o de um CER. Entretanto, \u00e9 fundamental que as pesquisas bibliogr\u00e1ficas sejam conduzidas em um processo sistem\u00e1tico:<\/p>\n<p>- Preparar um protocolo abrangente para a revis\u00e3o da literatura,<br \/>\n- Definir entradas e par\u00e2metros tais como bancos de dados, termos de busca e crit\u00e9rios de exclus\u00e3o (idiomas, tipo de estudo \/ projeto, configura\u00e7\u00e3o do estudo, pontos finais),<br \/>\n- Definir os crit\u00e9rios de seguran\u00e7a e desempenho necess\u00e1rios com base nos produtos equivalentes e na an\u00e1lise de risco,<br \/>\n- Reunir sistematicamente artigos relevantes de diferentes fontes de dados,<br \/>\n- Analisar os dados usando um m\u00e9todo objetivo, como uma estrutura e usando v\u00e1rios revisores, e,<br \/>\n- Conclus\u00f5es do documento de avalia\u00e7\u00e3o da literatura para inclus\u00e3o no documento CER.<\/p>\n<p><strong>Leia tamb\u00e9m: <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Como contratar um redator de Relat\u00f3rios de Avalia\u00e7\u00e3o Cl\u00ednica para seu dispositivo m\u00e9dico<\/a>\u00a0<\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_Determine_requirement_for_clinical_investigation\"><\/span>4. Determinar a necessidade de investiga\u00e7\u00e3o cl\u00ednica<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">A exig\u00eancia de uma investiga\u00e7\u00e3o cl\u00ednica \u00e9 determinada pelo perfil de risco do dispositivo. Os dispositivos de alto risco e Classe III devem ser submetidos a uma investiga\u00e7\u00e3o cl\u00ednica. A novidade tamb\u00e9m \u00e9 um fator determinante e os dispositivos baseados em tecnologias inovadoras ou para um novo uso pretendido com requerem investiga\u00e7\u00e3o cl\u00ednica. As evid\u00eancias cl\u00ednicas dispon\u00edveis devem abordar todas as ERs pertinentes. Isto pode ser assegurado compartilhando o Plano de Investiga\u00e7\u00e3o Cl\u00ednica (CIP) com a NB relevante antes da implementa\u00e7\u00e3o.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Monitor_post-market_activities\"><\/span>5. <strong>Monitorar as atividades p\u00f3s-mercado<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">Sob o MDR, as atividades de PMS devem ser adequadamente planejadas e documentadas no CER. Os processos de avalia\u00e7\u00e3o dos dados cl\u00ednicos em andamento e atualiza\u00e7\u00e3o das RCEs tamb\u00e9m devem ser documentados. Para garantir que a RCE permane\u00e7a relevante durante todo o ciclo de vida do produto, ela deve ser atualizada regularmente atrav\u00e9s de um processo documentado. Isto inclui a avalia\u00e7\u00e3o dos dados e a pondera\u00e7\u00e3o da relev\u00e2ncia de todos os dispositivos equivalentes.<\/p>\n<p><strong>Precisa de ajuda para escrever um relat\u00f3rio de avalia\u00e7\u00e3o cl\u00ednica? Contratar um freelance <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Escritor CER de Dispositivos M\u00e9dicos<\/a> em Kolabtree. \u00c9 gr\u00e1tis para postar seu projeto e receber or\u00e7amentos.<\/strong><\/p>\n<p>Peritos relacionados:<\/p>\n<p><strong><a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Consultores de Produtos m\u00e9dicos<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Escritor M\u00e9dico Freelancer<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Escritor aut\u00f4nomo do CER<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations--mdr-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Consultores MDR da UE<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Envios da FDA<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/services\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Especialistas em Pesquisa de Literatura<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-compliance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Peritos em Conformidade Regulat\u00f3ria<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Especialista em ensaios cl\u00ednicos<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Escritores Reguladores<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/post-market-surveillance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Consultores PMS<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/country\/india\/subject\/post-market-clinical-followup?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Consultores da PMCF<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u00a0Especialistas em Bioestat\u00edstica<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-development?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u00a0Especialista em desenvolvimento de produtos\u00a0<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Sophie Laurenson, healthcare &amp; technology innovator\u00a0on Kolabtree, shares 5 tips for writing a clinical evaluation report and defining a CER strategy. The EU MDR has significantly impacted the way medical devices are regulated in Europe. As part of regulatory compliance, medical device manufacturers need to create and maintain a Clinical Evaluation Report (CER), a document<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/writing-a-clinical-evaluation-report-5-quick-tips\/\" title=\"Leia mais\">Leia mais<\/a><\/div>","protected":false},"author":12,"featured_media":6882,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[247,443,540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Writing a Clinical Evaluation Report: 5 Quick Tips - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"Quick tips on writing a clinical evaluation report (CER) for medical device compliance with the EU MDR.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Writing a Clinical Evaluation Report: 5 Quick Tips\" \/>\n<meta property=\"og:description\" content=\"Quick tips on writing a clinical evaluation report (CER) for medical device compliance with the EU MDR.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/pt\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2020-02-07T13:14:07+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-04-06T12:36:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/02\/writing-a-clinical-evaluation-report.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"853\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. tempo de leitura\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutos\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Writing a Clinical Evaluation Report: 5 Quick Tips - 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