{"id":9307,"date":"2026-04-09T12:27:18","date_gmt":"2026-04-09T10:27:18","guid":{"rendered":"https:\/\/trigas-trigas-kunden.digitalspital.de\/nicht-kategorisiert\/iso-20916-explained-briefly\/"},"modified":"2026-06-15T11:16:13","modified_gmt":"2026-06-15T09:16:13","slug":"iso-20916","status":"publish","type":"post","link":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/iso-20916\/","title":{"rendered":"ISO 20916 briefly explained"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"9307\" class=\"elementor elementor-9307 elementor-4806\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1298576 e-flex e-con-boxed e-con e-parent\" data-id=\"1298576\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d913b9a elementor-widget elementor-widget-image\" data-id=\"d913b9a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"370\" src=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-ISO_1920x1080-1024x473.webp\" class=\"attachment-large size-large wp-image-7654\" alt=\"A person in a white shirt holds a pen and reviews printed documents on a desk, possibly referencing ISO 20916 standards while making notes on text, charts, and colorful graphics.\" srcset=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-ISO_1920x1080-1024x473.webp 1024w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-ISO_1920x1080-300x138.webp 300w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-ISO_1920x1080-768x354.webp 768w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-ISO_1920x1080-1536x709.webp 1536w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-ISO_1920x1080.webp 1950w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-721b626 elementor-widget elementor-widget-spacer\" data-id=\"721b626\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7b573dc elementor-widget elementor-widget-heading\" data-id=\"7b573dc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">What is ISO 20916?<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b293165 elementor-widget elementor-widget-text-editor\" data-id=\"b293165\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>ISO 20916 is an<strong> international standard for good study practice<\/strong>\u00a0specifically for clinical performance studies using in vitro diagnostic medical devices (IVDs). It is referenced in recital (66) of the IVDR corrigendum of 03\/05\/2019:<\/p><p><em>&#8220;The rules on performance studies should be in line with well-established international guidance in this field, such as the international standard ISO 20916 on clinical performance studies using specimens from human subjects (&#8230;).&#8221;<\/em><\/p><p><strong>The standard specifies how <\/strong><strong>clinical <\/strong><strong>performance studies<\/strong> <strong>are to be conducted under the IVDR and sets out requirements for key elements of study organisation and conduct, including:<\/strong><\/p><ul><li>Ethical considerations and informed consent of study participants<\/li><li>Study planning and roles\/responsibilities (sponsor, investigator)<\/li><li>Clinical performance study design<\/li><li>Clinical performance study plan\/protocol (CPSP), including endpoints<\/li><li>Investigator&#8217;s brochure<\/li><li>Study documentation and data integrity (e.g., <strong><a href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/crf-briefly-explained\/\" target=\"_blank\" rel=\"noopener\">CRF<\/a>\/<a href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/crf-briefly-explained\/\" target=\"_blank\" rel=\"noopener\">eCRF<\/a><\/strong>, audit trail)<\/li><li>Management of adverse events<\/li><li>Selection and qualification of study sites<\/li><li>Monitoring plan, quality management, and audits<\/li><li>Study initiation<\/li><li>Study conduct<\/li><li>Study close-out, data analysis, and reporting<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-45018c4 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"45018c4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-70045d2 elementor-widget elementor-widget-heading\" data-id=\"70045d2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 20916 Put Into Practice \u2013 A Brief Summary <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4ff36bd elementor-widget elementor-widget-text-editor\" data-id=\"4ff36bd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>To ensure robust results, define responsibilities and protect the subjects providing specimens, ISO 20916 specifies general requirements, such as:<\/p><ul><li><strong>Endpoints and population:<\/strong> clearly defined performance characteristics (e.g., sensitivity, specificity), and the IVD\u2019s target population<\/li><li><strong>Comparator:<\/strong> an appropriate reference method with justification<\/li><li><strong>Specimen management:<\/strong> pre-analytical conditions, storage and retention of samples, and traceability<\/li><li><strong>Statistics: <a href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/sample-size-calculation\/\" target=\"_blank\" rel=\"noopener\">sample size<\/a> <\/strong>and analysis plan<\/li><li><strong>Quality and safety:<\/strong> risk-based monitoring, deviations; reporting of adverse events and device deficiencies<\/li><li><strong>Electronic systems, documents, and regulatory authorities:<\/strong> CPSP, Investigator&#8217;s Brochure, and <strong><a href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/crf-briefly-explained\/\" target=\"_blank\" rel=\"noopener\">CRF\/eCRF<\/a><\/strong>; notification\/authorisation to national authorities under the IVDR<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b63ae84 elementor-widget elementor-widget-spacer\" data-id=\"b63ae84\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a889744 e-flex e-con-boxed e-con e-parent\" data-id=\"a889744\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-a74b491 e-con-full e-flex e-con e-child\" data-id=\"a74b491\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-96366fb e-con-full e-flex e-con e-child\" data-id=\"96366fb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-ec1e89e e-con-full e-flex e-con e-child\" data-id=\"ec1e89e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ed42b63 elementor-widget elementor-widget-heading\" data-id=\"ed42b63\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Want to learn more about applying ISO 20916 and GCP in performance studies? Get in touch.<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-26b827b elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"26b827b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact us now<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2a8c75f e-con-full e-flex e-con e-child\" data-id=\"2a8c75f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-3745067 e-con-full e-flex eael_liquid_glass-effect1 e-con e-child\" data-id=\"3745067\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8b114f0 elementor-widget elementor-widget-heading\" data-id=\"8b114f0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\"><b>Dr. Nina Miljanovic Jovanovic,<\/b> Senior Study Manager<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-44bc32fd e-flex e-con-boxed e-con e-parent\" data-id=\"44bc32fd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-25b6343d elementor-widget 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has-post-thumbnail hentry\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<div class=\"elementor-element elementor-element-945d7a9 e-flex e-con-boxed e-con e-parent\" data-id=\"945d7a9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6554424 elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"6554424\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-featured-image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"480\" src=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-1024x614.webp\" class=\"attachment-large size-large wp-image-7619\" alt=\"A scientist wearing blue gloves and safety glasses examines samples on a slide through a microscope in a laboratory, conducting ivdr performance studies with scientific equipment visible in the background.\" srcset=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-1024x614.webp 1024w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-300x180.webp 300w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-768x461.webp 768w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2-1536x922.webp 1536w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/03\/triga-s-Beitragsbild_Auftragsanalytik-und-applikation-1000x600-2.webp 2000w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-37ab487 e-con-full e-flex e-con e-child\" data-id=\"37ab487\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-45cfdc7 elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"45cfdc7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tFrom study planning through execution to submission-ready reports: TRIGA-S supports you with specialised expertise, a modular service portfolio, and a dedicated point of contact.\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e4d8fb elementor-widget elementor-widget-button\" data-id=\"8e4d8fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/diagnostics\/\" id=\"read-more-button\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Merh erfahren<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"5310\" class=\"elementor elementor-5310 e-loop-item e-loop-item-7380 post-7380 page type-page status-publish has-post-thumbnail hentry\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<div class=\"elementor-element elementor-element-945d7a9 e-flex e-con-boxed e-con e-parent\" data-id=\"945d7a9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6554424 elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"6554424\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-featured-image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"480\" src=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-1024x614.webp\" class=\"attachment-large size-large wp-image-7384\" alt=\"A scientist wearing safety goggles, gloves, and a lab coat stands in a laboratory specializing in pharma services, holding a piece of lab equipment and smiling at the camera. Shelves and lab supplies are visible in the background.\" srcset=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-1024x614.webp 1024w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-300x180.webp 300w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-768x461.webp 768w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1-1536x922.webp 1536w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_pharma-1000x600-1.webp 2000w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-37ab487 e-con-full e-flex e-con e-child\" data-id=\"37ab487\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-45cfdc7 elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"45cfdc7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tFrom exploratory R&amp;D analytics to submission-ready CDx validation: We support pharmaceutical companies with modular, IVDR-specialised services and dedicated points of contact.\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e4d8fb elementor-widget elementor-widget-button\" data-id=\"8e4d8fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/pharma-services\/\" id=\"read-more-button\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Merh erfahren<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-dd6cb82 e-flex e-con-boxed e-con e-parent\" data-id=\"dd6cb82\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-31dd286 e-con-full e-flex e-con e-child\" data-id=\"31dd286\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-614c1db elementor-widget__width-initial elementor-widget elementor-widget-n-accordion\" data-id=\"614c1db\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1020\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1020\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Abbreviations <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fontello fontelloarrow-up-right\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fontello fontelloarrow-down-right\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1020\" class=\"elementor-element elementor-element-3c25b4b e-con-full e-flex e-con e-child\" data-id=\"3c25b4b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0904a2c elementor-widget elementor-widget-text-editor\" data-id=\"0904a2c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>CPSP: Clinical Performance Study Plan\/Protocol<\/p><p>CRF: Case Report Form<\/p><p>eCRF: electronic Case Report Form<\/p><p>EUDAMED: European Database on Medical Devices<\/p><p>GCP: Good Clinical Practice<\/p><p>ISO: International Organization for Standardisation<\/p><p>IVDs: In vitro diagnostics<\/p><p>IVDR: In Vitro Diagnostic Regulation<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>What does ISO 20916 require for IVD studies? Get an overview of the key requirements this international standard sets out for study organisation. <\/p>\n","protected":false},"author":3,"featured_media":9308,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[25],"tags":[],"class_list":["post-9307","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cro-wiki"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISO 20916: Guidance for clinical performance studies<\/title>\n<meta name=\"description\" content=\"ISO 20916 complements the IVDR: Good Study Practice for IVDs with a focus on planning, CPSP, monitoring, ethics, and study conduct.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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