{"id":8895,"date":"2026-04-09T12:41:51","date_gmt":"2026-04-09T10:41:51","guid":{"rendered":"https:\/\/trigas-trigas-kunden.digitalspital.de\/nicht-kategorisiert\/trial-master-file-briefly-explained\/"},"modified":"2026-06-11T15:44:22","modified_gmt":"2026-06-11T13:44:22","slug":"trial-master-file","status":"publish","type":"post","link":"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/trial-master-file\/","title":{"rendered":"Trial Master File briefly explained"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8895\" class=\"elementor elementor-8895 elementor-4833\" 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-TMF_1920x1080-1024x473.webp\" class=\"attachment-large size-large wp-image-8897\" alt=\"Two people work at a table with laptops; one points at the screen while the other uses the keyboard, suggesting a collaborative discussion or problem-solving session related to a trial master file.\" srcset=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-TMF_1920x1080-1024x473.webp 1024w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-TMF_1920x1080-300x138.webp 300w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-TMF_1920x1080-768x354.webp 768w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-TMF_1920x1080-1536x709.webp 1536w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Headerbild_Beitrag-TMF_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 the Trial Master File (TMF) \u2013 and What Are the Regulatory Requirements?<\/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>The Trial Master File (TMF) is the <strong>structured collection of essential documents for a clinical trial or performance study<\/strong>. It demonstrates that the study was planned, conducted, evaluated, and documented in accordance with the study protocol, Good Clinical Practice (GCP), and applicable legal and regulatory requirements. The TMF is used by the sponsor, <strong><a href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/cro\/\" target=\"_blank\" rel=\"noopener\">CRO<\/a><\/strong>, and investigational sites, and serves as the primary source of evidence for auditors, and inspectors.<\/p>\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\">Why Is the TMF Critical?<\/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>The TMF is the &#8220;memory&#8221; of the study. It provides evidence of:<\/p><ul><li><strong>Compliance:<\/strong> Fulfilment of regulatory and GCP requirements, and effective risk management<\/li><li><strong>Transparency and Traceability:\u00a0<\/strong>Clear documentation of responsibilities, decisions, and timelines (who, what, when)<\/li><li><strong>Inspection Readiness:<\/strong> Rapid, complete access for audits and inspections \u2013 including remote access via an eTMF (electronic Trial Master File)<\/li><li><strong>Continuity:<\/strong> Seamless knowledge transfer during team changes, and a foundation for final reports, publications, and submissions of study results<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8aebd6b elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"8aebd6b\" 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-07cfe96 elementor-widget elementor-widget-heading\" data-id=\"07cfe96\" 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\">Examples of essential TMF documents<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c3dedf2 elementor-widget elementor-widget-text-editor\" data-id=\"c3dedf2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li><strong>Study Fundamentals:<\/strong> Protocol (CSP\/CPSP), Investigator&#8217;s Brochure, Statistical Analysis Plan, Monitoring Plan, ICF (Informed Consent Form) \u2013 the ICF documents the patient&#8217;s informed consent to participate in the study<\/li><li><span style=\"font-weight: bolder;\">Regulatory approvals and Ethics Committee:<\/span>\u00a0Ethics Committee opinions, regulatory notifications and approvals, correspondence<\/li><li><strong>Sites and Personnel:<\/strong> Site initiation documents, delegation logs, CVs and training records<\/li><li><strong>Conduct and Quality:<\/strong> Monitoring reports, protocol deviations\/violations, safety reports, evidence of communication<\/li><li><strong>Data and Completion: <\/strong>Data Management Plan<span style=\"font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', Arial, 'Noto Sans', sans-serif, 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Noto Color Emoji';\"><span style=\"font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', Arial, 'Noto Sans', sans-serif, 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Noto Color Emoji';\">, eCRF documentation, <\/span><\/span><span style=\"font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', Arial, 'Noto Sans', sans-serif, 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol', 'Noto Color Emoji';\">final report, archiving records<\/span><\/li><\/ul><p>\u00a0<\/p><p>Regulatory requirements do not distinguish between paper-based TMFs and eTMFs. For <strong>eTMFs<\/strong>, additional requirements for data integrity and system validation apply: every relevant action (data entry, data editing, system access, decisions, and study activities) must be fully traceable through audit trails. <strong>eTMF systems must be validated<\/strong> to demonstrate that they function as intended, and formal procedures (SOPs) for the management and quality assurance of the system must be in place.<\/p>\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-88122d3 e-flex e-con-boxed e-con e-parent\" data-id=\"88122d3\" 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-b9dfa5d e-con-full e-flex e-con e-child\" data-id=\"b9dfa5d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-350955f e-con-full e-flex e-con e-child\" data-id=\"350955f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-e8fac2d e-con-full e-flex e-con e-child\" data-id=\"e8fac2d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a1d4258 elementor-widget elementor-widget-heading\" data-id=\"a1d4258\" 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 know more about TMF and eTMF systems? \nGet in touch.<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fac60e2 elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"fac60e2\" 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-f852ba7 e-con-full e-flex e-con e-child\" data-id=\"f852ba7\" 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-5020a37 e-con-full e-flex eael_liquid_glass-effect1 e-con e-child\" data-id=\"5020a37\" 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-36101a4 elementor-widget elementor-widget-heading\" data-id=\"36101a4\" 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>Camilla Werle,<\/b> Senior CRA<\/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 elementor-widget-heading\" data-id=\"25b6343d\" 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\">You Might Also Be Interested In<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-41bb5b86 elementor-widget elementor-widget-spacer\" data-id=\"41bb5b86\" 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-757932f elementor-grid-3 elementor-grid-tablet-2 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"757932f\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;template_id&quot;:5310,&quot;_skin&quot;:&quot;post&quot;,&quot;columns&quot;:&quot;3&quot;,&quot;columns_tablet&quot;:&quot;2&quot;,&quot;columns_mobile&quot;:&quot;1&quot;,&quot;edit_handle_selector&quot;:&quot;[data-elementor-type=\\&quot;loop-item\\&quot;]&quot;,&quot;row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"loop-grid.post\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-loop-container elementor-grid\" role=\"list\">\n\t\t<style id=\"loop-5310\">.elementor-5310 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);}.elementor-widget-theme-post-excerpt{font-size:var( --e-global-typography-text-font-size );}}<\/style>\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"5310\" class=\"elementor elementor-5310 e-loop-item e-loop-item-7982 post-7982 post type-post status-publish format-standard has-post-thumbnail hentry category-cro-wiki\" 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\/04\/triga-s-Beitragsbild_Beitrag-cro-1000x600-V2-1024x614.webp\" class=\"attachment-large size-large wp-image-7983\" alt=\"Three CRO scientists wearing white lab coats and safety glasses stand smiling in a bright, modern laboratory, with shelves and equipment visible in the background.\" srcset=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-cro-1000x600-V2-1024x614.webp 1024w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-cro-1000x600-V2-300x180.webp 300w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-cro-1000x600-V2-768x461.webp 768w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-cro-1000x600-V2-1536x922.webp 1536w, https:\/\/trigas-trigas-kunden.digitalspital.de\/wp-content\/uploads\/2026\/04\/triga-s-Beitragsbild_Beitrag-cro-1000x600-V2.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\tWhat does a contract research organisation do? Learn more about the role and responsibilities of a CRO \u2013 especially for in vitro diagnostics (IVDs). \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\/cro-wiki\/cro\/\" 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-7617 post-7617 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 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-a8b55dc e-flex e-con-boxed e-con e-parent\" data-id=\"a8b55dc\" 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-bc798ac e-con-full e-flex e-con e-child\" data-id=\"bc798ac\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5614427 elementor-widget__width-initial elementor-widget elementor-widget-n-accordion\" data-id=\"5614427\" 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-9020\" 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-9020\" >\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-9020\" class=\"elementor-element elementor-element-d303422 e-con-full e-flex e-con e-child\" data-id=\"d303422\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4859b11 elementor-widget elementor-widget-text-editor\" data-id=\"4859b11\" 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>\n<p>CRO: Contract Research Organization<\/p>\n<p>CSP: Clinical Study Protocol<\/p>\n<p>CV: Curriculum Vitae<\/p>\n<p>eTMF: electronic Trial Master File<\/p>\n<p>GCP: Good Clinical Practice<\/p>\n<p>ICF: Informed Consent Form<\/p>\n<p>SOP: Standard Operating Procedure<\/p>\n<p>TMF: Trial Master File<\/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 is the TMF (Trial Master File) and why is it crucial for studies? Find out why it is considered the \u201cmemory\u201d of a study and which regulatory requirements it must meet.<\/p>\n","protected":false},"author":3,"featured_media":8896,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[25],"tags":[],"class_list":["post-8895","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>TMF (Trial Master File) and eTMF: Overview of requirements<\/title>\n<meta name=\"description\" content=\"In TMFs, study documents for the sponsor, CRO, and trial site are stored in a structured and audit-proof manner for clinical trials.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/trial-master-file\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"TMF (Trial Master File) and eTMF: Overview of requirements\" \/>\n<meta property=\"og:description\" content=\"In TMFs, study documents for the sponsor, CRO, and trial site are stored in a structured and audit-proof manner for clinical trials.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/trigas-trigas-kunden.digitalspital.de\/en\/cro-wiki\/trial-master-file\/\" \/>\n<meta property=\"og:site_name\" content=\"Triga-S Homepage\" \/>\n<meta property=\"article:published_time\" content=\"2026-04-09T10:41:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-06-11T13:44:22+00:00\" \/>\n<meta property=\"og:image\" 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