{"id":6581,"date":"2025-09-03T11:51:27","date_gmt":"2025-09-03T09:51:27","guid":{"rendered":"https:\/\/mediconomics.com\/glossar\/adverse-event\/"},"modified":"2026-06-08T21:12:36","modified_gmt":"2026-06-08T19:12:36","slug":"adverse-event","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/adverse-event\/","title":{"rendered":"Adverse Event"},"content":{"rendered":"<p>An adverse event (AE) refers to any untoward medical occurrence in a study participant during a clinical trial, regardless of whether there is a causal relationship with the investigational medicinal product. This definition, according to ICH-GCP, encompasses both serious and non-serious events and forms the basis for safety assessment in clinical trials. <\/p>\n<p>The correct collection and assessment of AEs is of critical importance for CROs, as they directly influence patient safety and regulatory compliance. Every AE must be documented in accordance with ICH-GCP guidelines, distinguishing between related and unrelated as well as expected and unexpected events. This classification is performed by the investigator and influences the reporting requirements to regulatory authorities.  <\/p>\n<p>In practice, this means that CROs must implement robust pharmacovigilance systems. The reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) to the EMA or national authorities must occur within strict timelines\u2014within 7 days for life-threatening events and within 15 days for other SUSARs. Modern eSafety systems support automated data collection and signal detection.  <\/p>\n<p><a href=\"https:\/\/mediconomics.com\/glossary\/\" data-wplink-edit=\"true\">Back to overview<\/a><\/p>\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>An adverse event (AE) refers to any untoward medical occurrence in a study participant during a clinical trial, regardless of whether there is a causal relationship with the investigational medicinal product. This definition, according to ICH-GCP, encompasses both serious and non-serious events and forms the basis for safety assessment in clinical trials. The correct collection [&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-6581","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\/6581","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\/6581\/revisions"}],"predecessor-version":[{"id":6582,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6581\/revisions\/6582"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6581"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6581"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}