A serious adverse event (SAE) is an adverse medical occurrence in a clinical trial that meets one of the defined severity criteria. These include death, life-threatening condition, hospitalization or prolongation of existing hospitalization, persistent or significant disability, congenital anomaly, or birth defect. SAE reporting is a central process in clinical pharmacovigilance and serves to protect trial participants. <\/p>\n
Regulation (EU) No 536\/2014 defines an SAE as an adverse medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or leads to a congenital anomaly or birth defect. ICH E2A adds that medically significant events may also be classified as serious if, although not immediately resulting in the aforementioned outcomes, they may require intervention to prevent such outcomes. <\/p>\n
“Serious” does not describe the same thing as the clinical intensity of a symptom. A severe but non-qualifying event may be medically serious without being an SAE. Conversely, an event with low symptom intensity may be an SAE if, for example, it requires hospitalization. Classification must therefore be based on the defined seriousness criteria and not solely on designations such as “mild,” “moderate,” or “severe.” <\/p>\n
The investigator documents safety-relevant information at the trial site and reports SAEs occurring in participants under his or her care to the sponsor, unless the protocol provides a different rule for specific SAEs. According to Article 41 of Regulation (EU) No 536\/2014, reporting must be immediate and no later than 24 hours after becoming aware. Required follow-up reports enable the sponsor to assess the impact on the benefit-risk balance of the trial. <\/p>\n
The sponsor evaluates the incoming information, particularly causality and expectedness. Only when a serious event is also assessed as an adverse drug reaction and is unexpected does a SUSAR exist. For SUSARs, the expedited electronic reporting timelines under Article 42 apply: for fatal or life-threatening cases, as soon as possible and no later than seven days after the sponsor becomes aware; for non-fatal and non-life-threatening cases, no later than 15 days thereafter. <\/p>\n
Reporting an SAE to the sponsor is therefore not equivalent to a SUSAR report to the EMA database. The initial report ensures that all important safety information is consolidated at the sponsor. The subsequent medical-regulatory assessment determines whether an expedited SUSAR report is triggered and what further measures, such as protocol amendment or notification to trial sites, are necessary. <\/p>\n
An adverse event (AE) is the umbrella term. It denotes an unfavorable medical occurrence in a person in a clinical trial, without implying a causal relationship with the medicinal product. An SAE is an AE that meets at least one of the statutory severity criteria. Every SAE is therefore an adverse event, but not every adverse event is serious. <\/p>\n
An adverse drug reaction, in contrast to an AE, requires at least a suspected causal relationship with the medicinal product. An SAE may therefore initially be recorded without a suspected relationship to the investigational product. If a relationship is assumed, it constitutes a serious adverse drug reaction. Causality assessment is a professional evaluation and must take into account the available clinical information. <\/p>\n
A SUSAR is more narrowly defined than an SAE. It is a suspected, unexpected, and serious adverse drug reaction. “Unexpected” means that the nature or severity of the reaction is not consistent with the available safety information on the investigational product. Therefore, not every SAE and not every serious adverse drug reaction triggers a SUSAR report. <\/p>\n
SAE processes must function at the trial site and at the sponsor from the first participant onward. Clear contact pathways, the 24-hour reporting requirement, a traceable follow-up process, and timely medical assessment enable the identification of safety risks and the maintenance of trial oversight. Monitoring verifies in particular that SAEs are completely documented in source, case report form, and safety documents and transmitted within the required timeframe. <\/p>\n
Full-service CROs such as Mediconomics support with study processes for pharmacovigilance, SAE recording and follow-up, training of trial sites, safety data management, medical documentation, and quality controls. The collaboration of Clinical Operations, Monitoring, Medical Writing, and Regulatory Affairs helps to consistently assess safety information, escalate in a timely manner, and prepare regulatory reports in a traceable manner. <\/p>\n
Is every adverse event an SAE?<\/strong><\/p>\n No. An adverse event is the broader term and does not require a causal relationship. An SAE exists only if at least one of the defined severity criteria is met. Clinical intensity alone does not determine SAE classification. <\/p>\n When does an SAE become a SUSAR?<\/strong><\/p>\n An SAE becomes a SUSAR when there is additionally a suspected relationship with the investigational product and the reaction is unexpected. The assessment of causality and expectedness is based on the available safety information; only SUSARs are subject to expedited reporting under Article 42 of Regulation (EU) No 536\/2014. <\/p>\n Within what timeframe must an SAE be reported to the sponsor?<\/strong><\/p>\n The investigator reports SAEs to the sponsor according to Article 41 of Regulation (EU) No 536\/2014 immediately and no later than 24 hours after becoming aware, unless the protocol provides a different rule for specific SAEs. This timeframe is distinct from the seven- and 15-day timelines for SUSAR reporting by the sponsor. <\/p>\n Not to be confused with the incident and serious incident under MDR vigilance: An SAE occurs during an ongoing clinical trial and concerns the safety of trial participants. An incident under MDR concerns medical devices already on the market and triggers a separate reporting obligation to the competent authority under Article 87. <\/p>\n","protected":false},"excerpt":{"rendered":" A serious adverse event (SAE) is an adverse medical occurrence in a clinical trial that meets one of the defined severity criteria. These include death, life-threatening condition, hospitalization or prolongation of existing hospitalization, persistent or significant disability, congenital anomaly, or birth defect. SAE reporting is a central process in clinical pharmacovigilance and serves to protect […]<\/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":[23],"class_list":["post-6665","glossary","type-glossary","status-publish","hentry","glossary-cat-pharmakovigilanz"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6665","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":2,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6665\/revisions"}],"predecessor-version":[{"id":7874,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6665\/revisions\/7874"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6665"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6665"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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