{"id":13656,"date":"2024-05-29T08:28:43","date_gmt":"2024-05-29T06:28:43","guid":{"rendered":"https:\/\/okomeds.com\/?p=13656"},"modified":"2024-06-17T10:27:07","modified_gmt":"2024-06-17T08:27:07","slug":"writing-and-translating-clinical-trial-protocols","status":"publish","type":"post","link":"https:\/\/okomeds.com\/es\/writing-and-translating-clinical-trial-protocols\/","title":{"rendered":"Writing and translating clinical trial protocols"},"content":{"rendered":"<p>You probably already know that clinical trials contribute each day to pharmacological knowledge and to the efficacy of medical treatments. To ensure good practice, the use of clinical trial protocols is mandatory. However, did you know that increasingly this also means translating clinical trial protocols and hiring <a href=\"https:\/\/okomeds.com\/\" target=\"_blank\" rel=\"noopener\">medical translation services<\/a>?<\/p>\n<p>Moreover, this must be taken very seriously since it requires specific medical and scientific knowledge. It must be written in clear, accurate language and be as precise as possible. This is essential to ensure that it is understandable and that there is consistency in all phases of the study requiring multi-language communication.<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/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\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><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><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/okomeds.com\/es\/writing-and-translating-clinical-trial-protocols\/#What_is_a_clinical_trial_protocol\" >What is a clinical trial protocol?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/okomeds.com\/es\/writing-and-translating-clinical-trial-protocols\/#What_information_should_be_included_in_a_clinical_trial_protocol\" >What information should be included in a clinical trial protocol?<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/okomeds.com\/es\/writing-and-translating-clinical-trial-protocols\/#Translating_clinical_trial_protocols\" >Translating clinical trial protocols<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/okomeds.com\/es\/writing-and-translating-clinical-trial-protocols\/#What_does_all_of_this_mean_Translating_clinical_trial_protocols_is_the_key_to_success\" >What does all of this mean? Translating clinical trial protocols is the key to success<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"What_is_a_clinical_trial_protocol\"><\/span><strong>What is a clinical trial protocol?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>All clinical research begins with the creation of a clinical protocol, a document that describes how a clinical trial will be conducted, including the objectives, design, methodology, statistical considerations and organisation of the trial to ensure the safety of the participants and the integrity of the data collected. The protocol is essential to ensure that clinical research is conducted properly and ethically, and that the results are accurate.<\/p>\n<div id=\"attachment_13774\" style=\"width: 310px\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/okomeds.com\/wp-content\/uploads\/2024\/05\/BLOG-PT-70-1.png\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-13774\" class=\"wp-image-13774 size-medium\" src=\"https:\/\/okomeds.com\/wp-content\/uploads\/2024\/05\/BLOG-PT-70-1-300x169.png\" alt=\"Writing a clinical trial protocol\" width=\"300\" height=\"169\" srcset=\"https:\/\/okomeds.com\/wp-content\/uploads\/2024\/05\/BLOG-PT-70-1-300x169.png 300w, https:\/\/okomeds.com\/wp-content\/uploads\/2024\/05\/BLOG-PT-70-1-539x303.png 539w, https:\/\/okomeds.com\/wp-content\/uploads\/2024\/05\/BLOG-PT-70-1.png 560w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a><p id=\"caption-attachment-13774\" class=\"wp-caption-text\">Writing a clinical trial protocol<\/p><\/div>\n<h3><span class=\"ez-toc-section\" id=\"What_information_should_be_included_in_a_clinical_trial_protocol\"><\/span>What information should be included in a clinical trial protocol?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>According to the ICH Good Clinical Practice guidelines, a protocol should include the following elements:<\/p>\n<ol>\n<li>\n<blockquote><p>Title page (general information)<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Background information<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Objectives\/purpose<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Study design<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Selection and exclusion of subjects<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Treatment of subjects<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Assessment of efficacy<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Assessment of safety<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Statistics<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Direct access to source data\/documents<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Quality control and assurance<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Ethics<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Data handling and recordkeeping<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Financing and insurance<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Publication policy<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Project timetable\/flowchart<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>References<\/p><\/blockquote>\n<\/li>\n<li>\n<blockquote><p>Supplements\/appendices<\/p><\/blockquote>\n<\/li>\n<\/ol>\n<h2><\/h2>\n<h2><span class=\"ez-toc-section\" id=\"Translating_clinical_trial_protocols\"><\/span>Translating clinical trial protocols<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Accurately writing a clinical trial protocol is a very important step, since it is the most important document to ensure that all aspects of the trial are well communicated to all stakeholders: scientists, potential participants, patients, etc. However, what is the role of the <a href=\"https:\/\/okomeds.com\/medical-translator\/\" target=\"_blank\" rel=\"noopener\">professional medical translator<\/a>?<\/p>\n<p>Correctly translating clinical trial protocols is essential for any clinical trial where you interact with people of different nationalities. Why?<\/p>\n<ol>\n<li><strong>It requires a lot of specialised knowledge<\/strong>: protocols contain medical terminology as well as administrative, legal, statistical, epidemiological and other terms that are not strictly medical.<\/li>\n<li>Clinical trial protocols require <strong>rigour, precision and clarity<\/strong>, since an error can have serious consequences and even endanger the lives of the people involved in the study.<\/li>\n<li><strong>Researchers<\/strong> who speak English as a second language <strong>may not fully understand the technical information and details contained in protocols in other languages<\/strong>. This can be dangerous.<\/li>\n<li>A high-quality <strong>translation<\/strong> of clinical study protocols <strong>saves time and increases the integrity of the study<\/strong>. And we all know that time is of the essence for doctors.<\/li>\n<li><strong>It provides guidance to all<\/strong> the people and organisations involved in the project, thus encouraging communication among them.<\/li>\n<li>It is a guarantee of patient safety and health.<\/li>\n<\/ol>\n<div id=\"attachment_13769\" style=\"width: 310px\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/okomeds.com\/wp-content\/uploads\/2024\/05\/BLOG-PT-69-1.png\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-13769\" class=\"wp-image-13769 size-medium\" src=\"https:\/\/okomeds.com\/wp-content\/uploads\/2024\/05\/BLOG-PT-69-1-300x169.png\" alt=\"Professional translation of protocols: a guarantee of quality\" width=\"300\" height=\"169\" srcset=\"https:\/\/okomeds.com\/wp-content\/uploads\/2024\/05\/BLOG-PT-69-1-300x169.png 300w, https:\/\/okomeds.com\/wp-content\/uploads\/2024\/05\/BLOG-PT-69-1-539x303.png 539w, https:\/\/okomeds.com\/wp-content\/uploads\/2024\/05\/BLOG-PT-69-1.png 560w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a><p id=\"caption-attachment-13769\" class=\"wp-caption-text\">Professional translation of protocols: a guarantee of quality<\/p><\/div>\n<h2><span class=\"ez-toc-section\" id=\"What_does_all_of_this_mean_Translating_clinical_trial_protocols_is_the_key_to_success\"><\/span>What does all of this mean? Translating clinical trial protocols is the key to success<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Simply put, the <a href=\"https:\/\/okomeds.com\/\" target=\"_blank\" rel=\"noopener\">professional medical translation<\/a>\u00a0of clinical trial protocols helps ensure the integrity of a study from start to finish.<\/p>\n<p>A properly translated study protocol can have a major impact on how the study is communicated to all parties involved. If an investigator does not properly understand the protocol, many mistakes can occur. This, in turn, can lead to lots of problems during the process of registering a new medicine, regardless of its proven efficacy and the benefits it can bring. After all, investigators cannot accurately translate hundreds of pages on their own.<\/p>\n<p>So, the key to success is providing the protocol in the language that allows its recipients to fully understand it.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>You probably already know that clinical trials contribute each day to pharmacological knowledge and to the efficacy of medical treatments. To ensure good practice, the use of clinical trial protocols is mandatory. However, did you know that increasingly this also means translating clinical trial protocols&#8230;<\/p>\n","protected":false},"author":16,"featured_media":13674,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-13656","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Writing and translating clinical trial protocols - Okomeds<\/title>\n<meta name=\"description\" content=\"Translating clinical trial protocols could be the key to success. 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