{"id":1156,"date":"2025-01-14T10:07:19","date_gmt":"2025-01-14T10:07:19","guid":{"rendered":"https:\/\/www.pharmity.com\/?post_type=news&#038;p=1156"},"modified":"2025-01-14T10:08:37","modified_gmt":"2025-01-14T10:08:37","slug":"1156","status":"publish","type":"news","link":"https:\/\/www.pharmity.com\/news\/1156\/","title":{"rendered":"FDA Draft Guidance Protocol Deviations for Clinical Investigations"},"content":{"rendered":"<p>In December 2024, the FDA published a draft guidance titled <em>&#8220;Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices.&#8221;<\/em> This guidance provides practical recommendations to standardize the management and reporting of protocol deviations in clinical trials. It emphasizes identifying deviations that could impact participant safety or data integrity, ensuring a consistent approach across studies.<\/p>\n<p>Key highlights include:<\/p>\n<ul>\n<li><strong>Clear Definitions<\/strong>: Introducing terms like &#8220;important protocol deviations&#8221; to enhance understanding and alignment.<\/li>\n<li><strong>Sponsor and Investigator Roles<\/strong>: Clarifying responsibilities in assessing and managing deviations.<\/li>\n<li><strong>Focus on Data Quality<\/strong>: Providing strategies to minimize deviations and mitigate their potential impact on trial outcomes.<\/li>\n<\/ul>\n<p>This draft offers valuable insights for optimizing clinical trial oversight while safeguarding data quality and participant safety.<\/p>\n<p>Stakeholders have until 28-February-2025, to submit feedback.<\/p>\n<p><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/protocol-deviations-clinical-investigations-drugs-biological-products-and-devices?utm_source=chatgpt.com\">FDA Draft Guidance &#8211; PDs for Clinical Investigations<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In December 2024, the FDA published a draft guidance titled &#8220;Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices.&#8221; This guidance provides practical recommendations to standardize the management and reporting of protocol deviations in clinical trials. It emphasizes identifying deviations that could impact participant safety or data integrity, ensuring a consistent approach across [&hellip;]<\/p>\n","protected":false},"featured_media":1104,"template":"","categories":[],"tags":[32,31,30],"class_list":["post-1156","news","type-news","status-publish","has-post-thumbnail","hentry","tag-clinical-investigations","tag-oversight","tag-protocol-devations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Draft Guidance Protocol Deviations for Clinical Investigations - Pharmity<\/title>\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.pharmity.com\/news\/1156\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Draft Guidance Protocol Deviations for Clinical Investigations - Pharmity\" \/>\n<meta property=\"og:description\" content=\"In December 2024, the FDA published a draft guidance titled &#8220;Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices.&#8221; This guidance provides practical recommendations to standardize the management and reporting of protocol deviations in clinical trials. It emphasizes identifying deviations that could impact participant safety or data integrity, ensuring a consistent approach across [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.pharmity.com\/news\/1156\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharmity\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-14T10:08:37+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.pharmity.com\/wp-content\/uploads\/2024\/11\/pexels-klaus-nielsen-6303654-scaled.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1707\" \/>\n\t<meta property=\"og:image:height\" content=\"2560\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.pharmity.com\/news\/1156\/\",\"url\":\"https:\/\/www.pharmity.com\/news\/1156\/\",\"name\":\"FDA Draft Guidance Protocol Deviations for Clinical Investigations - Pharmity\",\"isPartOf\":{\"@id\":\"https:\/\/www.pharmity.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.pharmity.com\/news\/1156\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.pharmity.com\/news\/1156\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.pharmity.com\/wp-content\/uploads\/2024\/11\/pexels-klaus-nielsen-6303654-scaled.webp\",\"datePublished\":\"2025-01-14T10:07:19+00:00\",\"dateModified\":\"2025-01-14T10:08:37+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.pharmity.com\/news\/1156\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.pharmity.com\/news\/1156\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.pharmity.com\/news\/1156\/#primaryimage\",\"url\":\"https:\/\/www.pharmity.com\/wp-content\/uploads\/2024\/11\/pexels-klaus-nielsen-6303654-scaled.webp\",\"contentUrl\":\"https:\/\/www.pharmity.com\/wp-content\/uploads\/2024\/11\/pexels-klaus-nielsen-6303654-scaled.webp\",\"width\":1707,\"height\":2560},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.pharmity.com\/news\/1156\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.pharmity.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FDA Draft Guidance Protocol Deviations for Clinical Investigations\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.pharmity.com\/#website\",\"url\":\"https:\/\/www.pharmity.com\/\",\"name\":\"Pharmity\",\"description\":\"Pharmacy + Quality\",\"publisher\":{\"@id\":\"https:\/\/www.pharmity.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.pharmity.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.pharmity.com\/#organization\",\"name\":\"Pharmity\",\"url\":\"https:\/\/www.pharmity.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.pharmity.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/i0.wp.com\/www.pharmity.com\/wp-content\/uploads\/2018\/05\/P-on-top-1.png?fit=548%2C348&ssl=1\",\"contentUrl\":\"https:\/\/i0.wp.com\/www.pharmity.com\/wp-content\/uploads\/2018\/05\/P-on-top-1.png?fit=548%2C348&ssl=1\",\"width\":548,\"height\":348,\"caption\":\"Pharmity\"},\"image\":{\"@id\":\"https:\/\/www.pharmity.com\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/pharmity\/\",\"https:\/\/www.pinterest.es\/pharmity\/\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"FDA Draft Guidance Protocol Deviations for Clinical Investigations - Pharmity","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:\/\/www.pharmity.com\/news\/1156\/","og_locale":"en_US","og_type":"article","og_title":"FDA Draft Guidance Protocol Deviations for Clinical Investigations - Pharmity","og_description":"In December 2024, the FDA published a draft guidance titled &#8220;Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices.&#8221; This guidance provides practical recommendations to standardize the management and reporting of protocol deviations in clinical trials. 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