{"id":6907,"date":"2026-01-13T09:47:20","date_gmt":"2026-01-13T08:47:20","guid":{"rendered":"https:\/\/mediconomics.com\/?post_type=glossary&#038;p=6907"},"modified":"2026-07-13T19:08:58","modified_gmt":"2026-07-13T17:08:58","slug":"data-integrity","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/data-integrity\/","title":{"rendered":"Data Integrity"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Data integrity refers to the completeness, consistency and accuracy of data throughout its entire lifecycle. In clinical research, it is the foundation of the trustworthiness of results. It is primarily defined by the ALCOA+ principles: data must be Attributable, Legible, Contemporaneous, Original and Accurate.<br \/>For CROs, ensuring data integrity is a core technological task. The use of validated computerised systems (EDC, eTMF) with complete audit trails ensures that every change to a data point remains traceable. Breaches of data integrity inevitably lead to rejection of study results by regulatory authorities and jeopardise the entire authorisation strategy.<br \/>During regulatory inspections (FDA 21 CFR Part 11 \/ EU Annex 11), data integrity is often a key focus. Inspectors examine the IT infrastructure, access rights and archiving processes. Proactive quality management implements regular data validations to ensure that the &#8216;chain of custody&#8217; of clinical data is never interrupted.<\/p>\n<p><a href=\"https:\/\/mediconomics.com\/en\/glossary\/\">Back to overview<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Data integrity refers to the completeness, consistency and accuracy of data throughout its entire lifecycle. In clinical research, it is the foundation of the trustworthiness of results. It is primarily defined by the ALCOA+ principles: data must be Attributable, Legible, Contemporaneous, Original and Accurate.For CROs, ensuring data integrity is a core technological task. The use [&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-6907","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\/6907","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\/6907\/revisions"}],"predecessor-version":[{"id":6908,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6907\/revisions\/6908"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6907"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6907"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}