{"id":6932,"date":"2026-01-13T10:20:53","date_gmt":"2026-01-13T09:20:53","guid":{"rendered":"https:\/\/mediconomics.com\/?post_type=glossary&#038;p=6932"},"modified":"2026-07-13T19:09:11","modified_gmt":"2026-07-13T17:09:11","slug":"essential-documents","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/essential-documents\/","title":{"rendered":"Essential Documents"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Essential Documents are, according to ICH-GCP, those documents which individually and collectively permit evaluation of the conduct of a clinical trial in accordance with the applicable standards. They form the backbone of the Trial Master File (TMF) and are crucial for the reconstruction of the trial by auditors or inspectors.<br \/>These include the protocol, the Investigator&#8217;s Brochure, ethics committee approvals, contracts, and documentation of subject consent. For CROs, managing these documents is an ongoing task in order to remain &#8220;inspection-ready&#8221; at all times. The absence of essential documents is one of the most common findings during regulatory inspections.<br \/>In modern research, these documents are managed almost exclusively in an eTMF. This enables global access, automated completeness checks, and audit-proof archiving. A complete TMF is a prerequisite for a successful marketing authorisation application, as it documents the quality of the entire data generation process.<\/p>\n<p><a href=\"https:\/\/mediconomics.com\/en\/glossary\/\">Back to overview<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Essential Documents are, according to ICH-GCP, those documents which individually and collectively permit evaluation of the conduct of a clinical trial in accordance with the applicable standards. They form the backbone of the Trial Master File (TMF) and are crucial for the reconstruction of the trial by auditors or inspectors.These include the protocol, the Investigator&#8217;s [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[],"class_list":["post-6932","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6932","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":1,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6932\/revisions"}],"predecessor-version":[{"id":6933,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6932\/revisions\/6933"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6932"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6932"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}