{"id":49187,"date":"2024-04-10T16:06:51","date_gmt":"2024-04-10T14:06:51","guid":{"rendered":"https:\/\/clariscience.com\/blog\/uncategorized\/la-struttura-logica-di-un-protocollo-clinico"},"modified":"2024-11-05T16:01:36","modified_gmt":"2024-11-05T15:01:36","slug":"the-logical-structure-of-a-clinical-protocol","status":"publish","type":"post","link":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol","title":{"rendered":"The logical structure of a clinical protocol"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"49187\" class=\"elementor elementor-49187 elementor-44113\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-90a491e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"90a491e\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9c6dece\" data-id=\"9c6dece\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9846dc0 elementor-widget elementor-widget-text-editor\" data-id=\"9846dc0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Planning clinical research<\/strong> is a well-structured process aimed at transforming an idea\u2014originating from a research question\u2014into clear, coherent, reliable, presentable, and contestable data. Within this complex and multifaceted process, drafting the <strong>clinical protocol<\/strong> is a crucial step for <strong>logically and thoroughly organizing the planned study.<\/strong><\/p><p>A clinical protocol is a <strong>document with scientific, operational, and ethical implications.<\/strong> It details a plan that outlines the <strong>objectives, methodology, design, and conduct of a clinical trial or study<\/strong>, specifying the <strong>criteria<\/strong> and binding the team to follow the procedures contained within. This helps protect participants from inappropriate and potentially dangerous operations.<\/p><p>Clinical protocols typically include information such as the<strong> purpose of the study,<\/strong> participant<strong> eligibility criteria,<\/strong> <strong>therapeutic interventions, dosing and administration schedules, data collection and analysis methods, safety monitoring procedures, and ethical considerations.<\/strong><\/p><h2>The Clinical Protocol in Outline<\/h2><p>While the <strong>specific requirements of the document may vary depending on the nature of the study and the regulations of the overseeing authority<\/strong> (in Italy, the requests for starting clinical investigations on medical devices are managed by the Ministry of Health), it is still possible to extrapolate a <strong>general structure<\/strong> for a clinical protocol.<\/p><ol><li><em><strong>Cover Page<\/strong>:<\/em> Includes a table with the protocol <strong>title<\/strong>, protocol <strong>number<\/strong>, creation <strong>date<\/strong>, <strong>revision<\/strong> number, <strong>names<\/strong> and <strong>affiliations<\/strong> of the investigators and any sponsors (if it is a for-profit study), and <strong>contact information for the principal investigator<\/strong> (PI).<\/li><li><em><strong>Table of Contents:<\/strong><\/em> Serves as an <strong>index<\/strong> listing all sections and subsections for easier navigation.<\/li><li><em><strong>Synopsis:<\/strong><\/em> Provides a <strong>brief description of the study&#8217;s objectives,<\/strong> including the experimental design and methodology.<\/li><li><strong><em>Background:<\/em><\/strong> Outlines the<strong> scientific and clinical foundations upon which the study is based.<\/strong> This section includes an <strong>objective literature review<\/strong> aimed at defining the scientific gaps the study seeks to address and how the obtained results will contribute to this goal.<\/li><li><strong><em>Study Objectives:<\/em><\/strong> Clearly states the <strong>primary objective<\/strong> of the study and, if applicable, any<strong> secondary objectives.<\/strong> The objectives should be specific, measurable, achievable, and time-bound.<\/li><li><strong><em>Experimental Design:<\/em><\/strong> Defines the <strong>characteristics of the study<\/strong> in terms of experimental design (e.g., randomized study, cohort study, case-control study), including detailed information on <strong>duration<\/strong>, <strong>inclusion\/exclusion criteria,<\/strong> and participant <strong>recruitment methods.<\/strong> If the protocol refers to a controlled study, the criteria for assigning participants to specific experimental groups must be defined, along with any <strong>randomization<\/strong> techniques used.<\/li><li><strong><em>Experimental Procedures:<\/em><\/strong> This section outlines the procedures followed during the study, including<strong> treatments, assessments, and follow-up visits.<\/strong> It is important to describe how data will be collected, recorded, and managed.<\/li><li><strong><em>Safety and Adverse Events:<\/em> <\/strong>Defines the <strong>procedures for monitoring the safety profile<\/strong> of the treatment during the study, describing how <strong>adverse events<\/strong> will be characterized and managed.<\/li><li><strong><em>Statistical Analysis Plan:<\/em><\/strong> Describes the <strong>statistical methods<\/strong> that will be applied. It specifies the <strong>number of participants<\/strong> based on sample size calculations and any<strong> interim analyses.<\/strong><\/li><li><em><strong>Ethical Considerations:<\/strong><\/em> Discusses ethical implications, including <strong>informed consent, data confidentiality and protection,<\/strong> and implications for <strong>vulnerable groups,<\/strong> defining strategies to ensure these principles.<\/li><li><em><strong>Data Management Plan:<\/strong><\/em> Defines <strong>procedures for data collection, storage, and analysis<\/strong> to ensure quality and integrity, specifying who will have access to the data and how confidentiality will be maintained.<\/li><li><strong><em>Quality Control and Assurance:<\/em><\/strong> Describes procedures for <strong>monitoring the study<\/strong> to ensure adherence to the protocol.<\/li><li><strong><em>Data Publication Policy:<\/em><\/strong> Explains how the <strong>dissemination of results<\/strong> will be managed.<\/li><li><em><strong>Bibliography:<\/strong> <\/em><strong>Lists sources<\/strong> referenced throughout the protocol.<\/li><li><em><strong>Appendix:<\/strong> <\/em>Attaches <strong>supporting documents,<\/strong> such as <strong>questionnaires, registration forms, and regulatory documents.<\/strong><\/li><\/ol><p>Each of these sections contributes to the<strong> drafting of a complete clinical protocol<\/strong>, ensuring that all aspects of the research are clearly defined and <strong>comply with regulatory requirements and ethical standards.<\/strong><\/p><p>Defining a<strong> clear and complete protocol<\/strong> is essential for <strong>planning clinical research.<\/strong> The scientific, methodological, and ethical nature of the clinical protocol facilitates the effective <strong>management of experimental phases<\/strong>. Although it is necessary to <strong>adapt the protocol to specific requirements<\/strong> related to the nature of the research and local legislation, a <strong>basic structure<\/strong> of information can be identified that is essential for this document.<\/p><p>Further Reading:<\/p><ol><li>De Riu, S., et al. \u201cHow to Plan a Clinical Study.\u201d Riv. dell\u2019Associazione Med. Diabetol 16 (2013): 377-383.\u00a0<\/li><\/ol><p>2. <a href=\"http:\/\/(https:\/\/www.ema.europa.eu\/en\/ich-e6-r2-good-clinical-practice-scientific-guideline\" data-wplink-url-error=\"true\">[EMA Guidelines]<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Planning clinical research is a well-structured process aimed at transforming an idea into clear, coherent, reliable, presentable, and contestable data.<\/p>\n","protected":false},"author":114,"featured_media":44118,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"episode_type":"","audio_file":"","podmotor_file_id":"","podmotor_episode_id":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","filesize_raw":"","date_recorded":"","explicit":"","block":"","powered_cache_disable_cache":false,"powered_cache_disable_css_optimization":false,"powered_cache_disable_js_optimization":false,"footnotes":""},"categories":[534],"tags":[575],"class_list":["post-49187","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-scientific-communication","tag-magazine-en"],"acf":[],"yoast_head":"<title>The logical structure of a clinical protocol | Clariscience magazine<\/title>\n<meta name=\"description\" content=\"A clinical protocol is a document with scientific, operational, and ethical implications. It details a plan that outlines the objectives, methodology, design, and conduct of a clinical trial or study.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The logical structure of a clinical protocol | Clariscience magazine\" \/>\n<meta property=\"og:description\" content=\"A clinical protocol is a document with scientific, operational, and ethical implications. It details a plan that outlines the objectives, methodology, design, and conduct of a clinical trial or study.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol\" \/>\n<meta property=\"og:site_name\" content=\"Clariscience\" \/>\n<meta property=\"article:published_time\" content=\"2024-04-10T14:06:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-05T15:01:36+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/clariscience.com\/wp-content\/uploads\/2024\/04\/432_R_La-struttura-logica-di-un-protocollo-clinico.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"628\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ennio Russo\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ennio Russo\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/scientific-communication\\\/the-logical-structure-of-a-clinical-protocol#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/scientific-communication\\\/the-logical-structure-of-a-clinical-protocol\"},\"author\":{\"name\":\"Ennio Russo\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#\\\/schema\\\/person\\\/56259fa009ae72ed6634fd5de153f3c1\"},\"headline\":\"The logical structure of a clinical protocol\",\"datePublished\":\"2024-04-10T14:06:51+00:00\",\"dateModified\":\"2024-11-05T15:01:36+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/scientific-communication\\\/the-logical-structure-of-a-clinical-protocol\"},\"wordCount\":691,\"publisher\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/scientific-communication\\\/the-logical-structure-of-a-clinical-protocol#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2024\\\/04\\\/432_Q_La-struttura-logica-di-un-protocollo-clinico.jpg\",\"keywords\":[\"magazine\"],\"articleSection\":[\"Scientific Communication\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/scientific-communication\\\/the-logical-structure-of-a-clinical-protocol\",\"url\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/scientific-communication\\\/the-logical-structure-of-a-clinical-protocol\",\"name\":\"The logical structure of a clinical protocol | Clariscience magazine\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/scientific-communication\\\/the-logical-structure-of-a-clinical-protocol#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/scientific-communication\\\/the-logical-structure-of-a-clinical-protocol#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2024\\\/04\\\/432_Q_La-struttura-logica-di-un-protocollo-clinico.jpg\",\"datePublished\":\"2024-04-10T14:06:51+00:00\",\"dateModified\":\"2024-11-05T15:01:36+00:00\",\"description\":\"A clinical protocol is a document with scientific, operational, and ethical implications. It details a plan that outlines the objectives, methodology, design, and conduct of a clinical trial or study.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/scientific-communication\\\/the-logical-structure-of-a-clinical-protocol#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/scientific-communication\\\/the-logical-structure-of-a-clinical-protocol\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/scientific-communication\\\/the-logical-structure-of-a-clinical-protocol#primaryimage\",\"url\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2024\\\/04\\\/432_Q_La-struttura-logica-di-un-protocollo-clinico.jpg\",\"contentUrl\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2024\\\/04\\\/432_Q_La-struttura-logica-di-un-protocollo-clinico.jpg\",\"width\":800,\"height\":800,\"caption\":\"la struttura di un protocollo clinico\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/scientific-communication\\\/the-logical-structure-of-a-clinical-protocol#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/clariscience.com\\\/en\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"The logical structure of a clinical protocol\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#website\",\"url\":\"https:\\\/\\\/clariscience.com\\\/en\",\"name\":\"Clariscience\",\"description\":\"Regulatory affairs, quality assurance, medical writing and communication\",\"publisher\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/clariscience.com\\\/en?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#organization\",\"name\":\"Clariscience Srl\",\"url\":\"https:\\\/\\\/clariscience.com\\\/en\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2019\\\/04\\\/logo-clariscience.svg\",\"contentUrl\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2019\\\/04\\\/logo-clariscience.svg\",\"width\":1,\"height\":1,\"caption\":\"Clariscience Srl\"},\"image\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#\\\/schema\\\/person\\\/56259fa009ae72ed6634fd5de153f3c1\",\"name\":\"Ennio Russo\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2022\\\/11\\\/Ennio-96x96.png\",\"url\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2022\\\/11\\\/Ennio-96x96.png\",\"contentUrl\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2022\\\/11\\\/Ennio-96x96.png\",\"caption\":\"Ennio Russo\"},\"description\":\"Medical Writing &amp; Scientific Communication Executive, Ph.D.\",\"sameAs\":[\"https:\\\/\\\/clariscience.com\\\/raqa-underground-pmcf\"],\"url\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/author\\\/ennio-russoclariscience-com\"}]}<\/script>","yoast_head_json":{"title":"The logical structure of a clinical protocol | Clariscience magazine","description":"A clinical protocol is a document with scientific, operational, and ethical implications. It details a plan that outlines the objectives, methodology, design, and conduct of a clinical trial or study.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol","og_locale":"en_US","og_type":"article","og_title":"The logical structure of a clinical protocol | Clariscience magazine","og_description":"A clinical protocol is a document with scientific, operational, and ethical implications. It details a plan that outlines the objectives, methodology, design, and conduct of a clinical trial or study.","og_url":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol","og_site_name":"Clariscience","article_published_time":"2024-04-10T14:06:51+00:00","article_modified_time":"2024-11-05T15:01:36+00:00","og_image":[{"width":1200,"height":628,"url":"https:\/\/clariscience.com\/wp-content\/uploads\/2024\/04\/432_R_La-struttura-logica-di-un-protocollo-clinico.jpg","type":"image\/jpeg"}],"author":"Ennio Russo","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Ennio Russo","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol#article","isPartOf":{"@id":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol"},"author":{"name":"Ennio Russo","@id":"https:\/\/clariscience.com\/en#\/schema\/person\/56259fa009ae72ed6634fd5de153f3c1"},"headline":"The logical structure of a clinical protocol","datePublished":"2024-04-10T14:06:51+00:00","dateModified":"2024-11-05T15:01:36+00:00","mainEntityOfPage":{"@id":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol"},"wordCount":691,"publisher":{"@id":"https:\/\/clariscience.com\/en#organization"},"image":{"@id":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol#primaryimage"},"thumbnailUrl":"https:\/\/clariscience.com\/wp-content\/uploads\/2024\/04\/432_Q_La-struttura-logica-di-un-protocollo-clinico.jpg","keywords":["magazine"],"articleSection":["Scientific Communication"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol","url":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol","name":"The logical structure of a clinical protocol | Clariscience magazine","isPartOf":{"@id":"https:\/\/clariscience.com\/en#website"},"primaryImageOfPage":{"@id":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol#primaryimage"},"image":{"@id":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol#primaryimage"},"thumbnailUrl":"https:\/\/clariscience.com\/wp-content\/uploads\/2024\/04\/432_Q_La-struttura-logica-di-un-protocollo-clinico.jpg","datePublished":"2024-04-10T14:06:51+00:00","dateModified":"2024-11-05T15:01:36+00:00","description":"A clinical protocol is a document with scientific, operational, and ethical implications. It details a plan that outlines the objectives, methodology, design, and conduct of a clinical trial or study.","breadcrumb":{"@id":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol#primaryimage","url":"https:\/\/clariscience.com\/wp-content\/uploads\/2024\/04\/432_Q_La-struttura-logica-di-un-protocollo-clinico.jpg","contentUrl":"https:\/\/clariscience.com\/wp-content\/uploads\/2024\/04\/432_Q_La-struttura-logica-di-un-protocollo-clinico.jpg","width":800,"height":800,"caption":"la struttura di un protocollo clinico"},{"@type":"BreadcrumbList","@id":"https:\/\/clariscience.com\/en\/blog\/scientific-communication\/the-logical-structure-of-a-clinical-protocol#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/clariscience.com\/en"},{"@type":"ListItem","position":2,"name":"The logical structure of a clinical protocol"}]},{"@type":"WebSite","@id":"https:\/\/clariscience.com\/en#website","url":"https:\/\/clariscience.com\/en","name":"Clariscience","description":"Regulatory affairs, quality assurance, medical writing and communication","publisher":{"@id":"https:\/\/clariscience.com\/en#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/clariscience.com\/en?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/clariscience.com\/en#organization","name":"Clariscience Srl","url":"https:\/\/clariscience.com\/en","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/clariscience.com\/en#\/schema\/logo\/image\/","url":"https:\/\/clariscience.com\/wp-content\/uploads\/2019\/04\/logo-clariscience.svg","contentUrl":"https:\/\/clariscience.com\/wp-content\/uploads\/2019\/04\/logo-clariscience.svg","width":1,"height":1,"caption":"Clariscience Srl"},"image":{"@id":"https:\/\/clariscience.com\/en#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/clariscience.com\/en#\/schema\/person\/56259fa009ae72ed6634fd5de153f3c1","name":"Ennio Russo","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/clariscience.com\/wp-content\/uploads\/2022\/11\/Ennio-96x96.png","url":"https:\/\/clariscience.com\/wp-content\/uploads\/2022\/11\/Ennio-96x96.png","contentUrl":"https:\/\/clariscience.com\/wp-content\/uploads\/2022\/11\/Ennio-96x96.png","caption":"Ennio Russo"},"description":"Medical Writing &amp; Scientific Communication Executive, Ph.D.","sameAs":["https:\/\/clariscience.com\/raqa-underground-pmcf"],"url":"https:\/\/clariscience.com\/en\/blog\/author\/ennio-russoclariscience-com"}]}},"_links":{"self":[{"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/posts\/49187","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/users\/114"}],"replies":[{"embeddable":true,"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/comments?post=49187"}],"version-history":[{"count":0,"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/posts\/49187\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/media\/44118"}],"wp:attachment":[{"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/media?parent=49187"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/categories?post=49187"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/tags?post=49187"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}