{"id":234,"date":"2015-04-01T14:40:46","date_gmt":"2015-04-01T14:40:46","guid":{"rendered":"https:\/\/saude.ufpr.br\/cometica\/?page_id=234"},"modified":"2025-11-07T15:35:40","modified_gmt":"2025-11-07T15:35:40","slug":"modelo-de-solicitacao-relatorios","status":"publish","type":"page","link":"https:\/\/saude.ufpr.br\/cometica\/modelo-de-solicitacao-relatorios\/","title":{"rendered":"Modelo de Relat\u00f3rio e Manual de Notifica\u00e7\u00e3o"},"content":{"rendered":"<div class=\"entry-header\">\n<h4 style=\"text-align: justify\"><strong><span style=\"text-align: justify;font-size: 16px\">Ap\u00f3s aprova\u00e7\u00e3o do protocolo de pesquisa pelo CEP\/SD \u00e9 de responsabilidade do(a) Pesquisador(a) principal enviar relat\u00f3rios parciais (semestralmente), e o relat\u00f3rio final, quando do t\u00e9rmino do estudo (Resolu\u00e7\u00e3o 466\/2012, XI.2.d e Resolu\u00e7\u00e3o 510\/16, Art. 28, V).<\/span><\/strong><\/h4>\n<\/div>\n<div>\n<p>Os relat\u00f3rios devem ser enviados por &#8220;Notifica\u00e7\u00e3o&#8221; via Plataforma Brasil.<\/p>\n<\/div>\n<p>A observ\u00e2ncia dos prazos de envio dos relat\u00f3rios parciais ou finais e das respostas \u00e0s pend\u00eancias \u00e9 estritamente de responsabilidade do pesquisador. A n\u00e3o obedi\u00eancia aos prazos estipulados implica na N\u00c3O APROVA\u00c7\u00c3O dos relat\u00f3rios e\/ou protocolos.<\/p>\n<p>Verifique o passo a passo para envio de notifica\u00e7\u00f5es no <a href=\"https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2016\/08\/Envio-notifica\u00e7\u00e3o-3.0.pdf\"><strong>Manual de submiss\u00e3o de Notifica\u00e7\u00e3o (Clique aqui)<\/strong><\/a>, ou <strong><a href=\"https:\/\/www.youtube.com\/watch?v=bIYK_0luq4A\" target=\"_blank\" rel=\"noopener\">assista ao v\u00eddeo &#8220;Envio de Notifica\u00e7\u00e3o na Plataforma Brasil&#8221; elaborado pela CONEP\u00a0<\/a><\/strong>(Fonte: CONEP)<\/p>\n<p><iframe title=\"Envio de Notifica\u00e7\u00e3o na Plataforma Brasil\" width=\"500\" height=\"281\" src=\"https:\/\/www.youtube.com\/embed\/bIYK_0luq4A?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Modelo 01:<\/strong><\/p>\n<p><a href=\"https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2015\/04\/relatorio_suspensao_estudo1.pdf\">01 -Relat\u00f3rio de suspens\u00e3o do estudo<\/a><\/p>\n<p><strong>Modelo 02<\/strong><\/p>\n<h1 class=\"western\" style=\"text-align: center\"><span style=\"color: #3465a4\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">RELAT\u00d3RIO PARCIAL ou RELAT\u00d3RIO FINAL<\/span><\/span><\/span><\/h1>\n<p class=\"western\" align=\"center\"><span style=\"color: #a7074b\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">(Identificar qual relat\u00f3rio ser\u00e1 enviado, apagar o outro)<\/span><\/span><\/span><\/p>\n<h2 class=\"western\" align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">CAAE: <\/span><\/span><\/h2>\n<h3 class=\"western\" align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">T\u00edtulo da Pesquisa: <\/span><\/span><\/h3>\n<p class=\"western\" align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\"><b>Nome Pesquisador Respons\u00e1vel:<\/b><\/span><\/span><\/p>\n<p class=\"western\" align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\"><b>Local onde foi realizada a pesquisa:<\/b><\/span><\/span><\/p>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\"><b>Resumo do projeto:<\/b><\/span><\/span><\/p>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">1 . Introdu\u00e7\u00e3o:<\/span><\/span><\/p>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">2. Objetivos:<\/span><\/span><\/p>\n<p align=\"left\">3. Riscos e Benef\u00edcios<\/p>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">4. M\u00e9todo:<\/span><\/span><\/p>\n<p align=\"left\"><span style=\"color: #000000\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">5 . Resultados:<\/span><\/span><\/span><\/p>\n<p align=\"left\"><span style=\"color: #a7074b\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">* Complementar, para relat\u00f3rio final:<\/span><\/span><\/span><\/p>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">6. Conclus\u00f5es:<\/span><\/span><\/p>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">7. Dificuldades \u00e9ticas na realiza\u00e7\u00e3o do estudo.<\/span><\/span><\/p>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">8. Danos colaterais, eventos adversos, situa\u00e7\u00f5es de desconforto ou risco eventualmente observados no decorrer do estudo e medidas tomadas para minimiza\u00e7\u00e3o ou solu\u00e7\u00e3o.<\/span><\/span><\/p>\n<p><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\"><b>Situa\u00e7\u00e3o da Pesquisa<\/b><\/span><\/span><\/p>\n<table width=\"628\" cellspacing=\"0\" cellpadding=\"0\">\n<colgroup>\n<col width=\"332\" \/>\n<col width=\"296\" \/> <\/colgroup>\n<tbody>\n<tr valign=\"top\">\n<td width=\"332\" height=\"27\">\n<p class=\"western\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">( ) Em andamento<\/span><\/span><\/p>\n<\/td>\n<td width=\"296\">\n<p class=\"western\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Previs\u00e3o de conclus\u00e3o: \/ \/<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<tr valign=\"top\">\n<td width=\"332\" height=\"27\">\n<p class=\"western\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">( ) Ainda n\u00e3o foi iniciada<\/span><\/span><\/p>\n<\/td>\n<td width=\"296\">\n<p class=\"western\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Previs\u00e3o de in\u00edcio: \/ \/<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" valign=\"top\" width=\"628\" height=\"27\">\n<p class=\"western\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">( ) Suspensa<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\" valign=\"top\" width=\"628\" height=\"27\">\n<p class=\"western\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">( ) Conclu\u00edda Data de conclus\u00e3o: \/ \/ <\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ol type=\"a\">\n<li>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Qual o tamanho da amostra alocada no estudo?<\/span><\/span><\/p>\n<\/li>\n<\/ol>\n<ol start=\"2\" type=\"a\">\n<li>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Qual o tamanho de amostra proposto para o estudo? (Justificar altera\u00e7\u00f5es se houver)<\/span><\/span><\/p>\n<\/li>\n<\/ol>\n<ol start=\"3\" type=\"a\">\n<li>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Houve necessidade de altera\u00e7\u00e3o na estrutura do projeto atrav\u00e9s de Emenda? T\u00edtulo? Material? M\u00e9todo? Detalhar e justificar altera\u00e7\u00f5es.<\/span><\/span><\/p>\n<\/li>\n<\/ol>\n<p align=\"left\"><span style=\"color: #a7074b\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">* Qualquer altera\u00e7\u00e3o no projeto apresentado ao CEP, por emendas, deve constar no relat\u00f3rio final.<\/span><\/span><\/span><\/p>\n<p class=\"western\" align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\"><b>QUESTIONAMENTOS <\/b><\/span><\/span><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\"><b>(Somente para ensaios cl\u00ednicos)<\/b><\/span><\/span><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\"><b>:<\/b><\/span><\/span><\/p>\n<ol>\n<li>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Total de participantes recrutados neste centro e no total:<\/span><\/span><\/p>\n<\/li>\n<li>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Total de participantes efetivamente inclu\u00eddos no estudo (ap\u00f3s a randomiza\u00e7\u00e3o) neste centro e no total:<\/span><\/span><\/p>\n<\/li>\n<li>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Total de participantes que conclu\u00edram o estudo neste centro e no total:<\/span><\/span><\/p>\n<\/li>\n<li>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Principais raz\u00f5es de retirada\/descontinua\u00e7\u00e3o <\/span><\/span><\/p>\n<\/li>\n<li>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Total de eventos s\u00e9rios ocorridos neste centro e no total:<\/span><\/span><\/p>\n<\/li>\n<li>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Condutas adotadas em rela\u00e7\u00e3o aos eventos adversos graves;<\/span><\/span><\/p>\n<\/li>\n<\/ol>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">\u00a0 \u00a0 \u00a07. Houve pedido de indeniza\u00e7\u00e3o por danos causados por este estudo neste centro e no total <\/span><\/span><\/p>\n<ul>\n<li>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Se sim, quantos?<\/span><\/span><\/p>\n<\/li>\n<li>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Qual foi o dano?<\/span><\/span><\/p>\n<\/li>\n<li>\n<p align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Qual conduta tomada?<\/span><\/span><\/p>\n<\/li>\n<\/ul>\n<p class=\"western\" align=\"left\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">\u00a0<\/span><\/span><\/p>\n<h5 class=\"western\" align=\"left\"><span style=\"color: #ce181e\"><span style=\"font-family: Arial, serif\"><span style=\"font-size: medium\">Observa\u00e7\u00f5es:<\/span><\/span><\/span><\/h5>\n<ul>\n<li>\n<h5 class=\"western\" align=\"left\"><span style=\"font-family: Arial, serif;color: #008000\"><span style=\"font-size: medium\">N\u00e3o preencher manualmente o formul\u00e1rio.<\/span><\/span><\/h5>\n<\/li>\n<li>\n<h5 class=\"western\" align=\"left\"><span style=\"font-family: Arial, serif;color: #008000\"><span style=\"font-size: medium\">Relat\u00f3rio final: dever\u00e1 ser enviado ao CEP preenchido, no m\u00e1ximo 30 dias ap\u00f3s a conclus\u00e3o da pesquisa. <\/span><\/span><\/h5>\n<\/li>\n<li>\n<p class=\"western\" align=\"left\"><strong><span style=\"font-family: Arial, serif;color: #008000\"><span style=\"font-size: medium\">Os relat\u00f3rios devem ser enviados em Word (.doc).<\/span><\/span><\/strong><\/p>\n<\/li>\n<\/ul>\n<p><span style=\"color: #ff0000\"><span style=\"font-family: Helvetica, serif\">*Importante: as dicas de preenchimento, dados que n\u00e3o fazem parte de sua pesquisa n\u00e3o precisam constar do relat\u00f3rio, portanto, as observa\u00e7\u00f5es n\u00e3o precisam constar do documento, caso sua pesquisa n\u00e3o tenha: Question\u00e1rios (ensaio cl\u00ednico), n\u00e3o precisa colocar esta informa\u00e7\u00e3o no seus relat\u00f3rio<!-- No seu relat\u00f3rio ou nos seus relat\u00f3rios? -->.<\/span><\/span><\/p>\n<p><span style=\"color: #ff0000\">As frases:( * Para Relat\u00f3rio Final, complementar: e * Qualquer altera\u00e7\u00e3o no projeto apresentado ao CEP deve constar no relat\u00f3rio final. ) S\u00e3o para ajud\u00e1-los ao preenchimento, estas tamb\u00e9m n\u00e3o precisam estar descritas no relat\u00f3rio.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ap\u00f3s aprova\u00e7\u00e3o do protocolo de pesquisa pelo CEP\/SD \u00e9 de responsabilidade do(a) Pesquisador(a) principal enviar relat\u00f3rios parciais (semestralmente), e o relat\u00f3rio final, quando do t\u00e9rmino do estudo (Resolu\u00e7\u00e3o 466\/2012, XI.2.d e Resolu\u00e7\u00e3o 510\/16, Art. 28, V). Os relat\u00f3rios devem ser enviados por &#8220;Notifica\u00e7\u00e3o&#8221; via Plataforma Brasil. A observ\u00e2ncia dos prazos de envio dos relat\u00f3rios parciais [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":1106,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-234","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"featured_image_src":"https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2017\/10\/importante.png","uagb_featured_image_src":{"full":["https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2017\/10\/importante.png",731,500,false],"thumbnail":["https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2017\/10\/importante-150x150.png",150,150,true],"medium":["https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2017\/10\/importante-300x205.png",300,205,true],"medium_large":["https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2017\/10\/importante.png",731,500,false],"large":["https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2017\/10\/importante.png",731,500,false],"1536x1536":["https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2017\/10\/importante.png",731,500,false],"2048x2048":["https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2017\/10\/importante.png",731,500,false],"noticias-thumb":["https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2017\/10\/importante-580x326.png",580,326,true],"banners-thumb":["https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2017\/10\/importante-731x150.png",731,150,true],"maisnoticias-thumb":["https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2017\/10\/importante-160x90.png",160,90,true],"post-thumbnail":["https:\/\/saude.ufpr.br\/cometica\/wp-content\/uploads\/sites\/7\/2017\/10\/importante-300x205.png",300,205,true]},"uagb_author_info":{"display_name":"josete","author_link":"https:\/\/saude.ufpr.br\/cometica\/author\/josete\/"},"uagb_comment_info":0,"uagb_excerpt":"Ap\u00f3s aprova\u00e7\u00e3o do protocolo de pesquisa pelo CEP\/SD \u00e9 de responsabilidade do(a) Pesquisador(a) principal enviar relat\u00f3rios parciais (semestralmente), e o relat\u00f3rio final, quando do t\u00e9rmino do estudo (Resolu\u00e7\u00e3o 466\/2012, XI.2.d e Resolu\u00e7\u00e3o 510\/16, Art. 28, V). Os relat\u00f3rios devem ser enviados por &#8220;Notifica\u00e7\u00e3o&#8221; via Plataforma Brasil. A observ\u00e2ncia dos prazos de envio dos relat\u00f3rios parciais&hellip;","publishpress_future_action":{"enabled":false,"date":"2026-04-11 02:16:08","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/saude.ufpr.br\/cometica\/wp-json\/wp\/v2\/pages\/234","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/saude.ufpr.br\/cometica\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/saude.ufpr.br\/cometica\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/saude.ufpr.br\/cometica\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/saude.ufpr.br\/cometica\/wp-json\/wp\/v2\/comments?post=234"}],"version-history":[{"count":31,"href":"https:\/\/saude.ufpr.br\/cometica\/wp-json\/wp\/v2\/pages\/234\/revisions"}],"predecessor-version":[{"id":2757,"href":"https:\/\/saude.ufpr.br\/cometica\/wp-json\/wp\/v2\/pages\/234\/revisions\/2757"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/saude.ufpr.br\/cometica\/wp-json\/wp\/v2\/media\/1106"}],"wp:attachment":[{"href":"https:\/\/saude.ufpr.br\/cometica\/wp-json\/wp\/v2\/media?parent=234"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}