{"id":6587,"date":"2025-09-03T11:51:27","date_gmt":"2025-09-03T09:51:27","guid":{"rendered":"https:\/\/mediconomics.com\/glossar\/alcoa-principles\/"},"modified":"2025-09-03T11:51:27","modified_gmt":"2025-09-03T09:51:27","slug":"alcoa-principles","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/alcoa-principles\/","title":{"rendered":"ALCOA+ Principles"},"content":{"rendered":"<p>ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, and Accurate, as well as Complete, Consistent, Enduring, and Available\u2014 the fundamental principles of data integrity in clinical trials. These criteria, developed by the FDA, define how clinical data must be captured, processed, and archived to meet regulatory standards. <\/p>\n<p>Implementing the ALCOA+ principles in CRO operations requires robust systems and processes. \u201cAttributable\u201d means that every data change can be assigned to a specific user. \u201cLegible\u201d ensures the lasting readability of all data. \u201cContemporaneous\u201d requires the prompt documentation of events. \u201cOriginal\u201d refers to the first record or an exact copy. \u201cAccurate\u201d requires error-free data capture.     <\/p>\n<p>The extended principles (the \u201cPlus\u201d) address modern challenges in digital data processing. \u201cComplete\u201d means that all required data are present. \u201cConsistent\u201d requires uniform formats and procedures. \u201cEnduring\u201d ensures the long-term integrity and availability of data throughout the entire archiving period. \u201cAvailable\u201d ensures that data are accessible to authorized persons. CROs must integrate these principles into their eCRF systems, data management processes, and archiving strategies.     <\/p>\n<p><a href=\"https:\/\/mediconomics.com\/glossary\/\">Back to overview<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, and Accurate, as well as Complete, Consistent, Enduring, and Available\u2014 the fundamental principles of data integrity in clinical trials. These criteria, developed by the FDA, define how clinical data must be captured, processed, and archived to meet regulatory standards. Implementing the ALCOA+ principles in CRO operations requires robust [&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":"default","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-6587","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\/6587","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":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6587\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6587"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6587"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}