Screening in clinical trials is the protocol-specified check of whether a potential participant is suitable for a specific study. It takes place after informed consent and before inclusion in the study population. Screening can include medical history, findings, laboratory values, or other examinations defined in the protocol.<\/p>\n
Screening does not begin with an arbitrary diagnostic measure. Prior to study-specific examinations, informed consent must be effectively obtained, provided no data from standard care are used in accordance with applicable law. Regulation (EU) No 536\/2014 requires written, dated, and signed consent after a preceding information discussion. The potential participant must be sufficiently informed and have the opportunity to ask questions.<\/p>\n
Afterwards, the investigator site performs the steps foreseen in the protocol. These can include the review of medical history and concomitant medication, physical examination, pregnancy test, laboratory test, ECG, or imaging examination. Which data are collected and which time windows apply must be clearly described by the protocol. Screening data are study data and must be handled traceably, confidentially, and in accordance with data retention specifications even for non-included individuals.<\/p>\n
Suitability is assessed based on the inclusion and exclusion criteria defined in the protocol. These criteria define the study population and should support the study objectives as well as enable an appropriate benefit-risk assessment. ICH E8(R1) emphasizes that the population to be studied is defined by inclusion and exclusion criteria. The investigator assesses on this basis whether the person can be included in the study.<\/p>\n
A screening process needs clear evidence for the criteria and clear responsibilities for assessment, inquiries, and documentation. If data are missing or findings lie outside a permissible range, an inclusion must not be generated through informal interpretation. Permissible repetitions of examinations, windows for values, or rules on prior treatments must be stated in advance in the protocol. Deviations are to be handled according to the defined quality process.<\/p>\n
If a person does not fulfill a criterion, withdraws consent, or is not included for another protocol-defined reason, this is frequently referred to as a screening failure. The term does not describe a medical failure of the person, but the result of the eligibility process for this study at this point in time. The reason must be documented in such a way that recruitment, the selection process, and, if applicable, safety aspects remain traceable.<\/p>\n
Re-screening means a renewed eligibility check after a first unsuccessful or expired screening. It is only permissible if the protocol or a clearly documented study-specific rule allows this. The reasons for the renewed check, renewed or continuously valid consent, the repetition of examinations, and the identifier used must be traceable. Re-screening must not serve to circumvent inclusion and exclusion criteria or to conceal unfavorable data.<\/p>\n
Screening is the process of eligibility checking. Inclusion and exclusion criteria, on the other hand, are the pre-defined rules according to which this eligibility is assessed. They do not themselves define the course of the examinations, but specify the prerequisites for inclusion. Both terms belong together, but remain technically separate: criteria are rules, screening is their documented application.<\/p>\n
Baseline is also not a synonym for screening. Baseline designates the initial values collected before the start of the study treatment or another defined reference time point, which serve for later comparisons. Individual screening data can be used as baseline if the protocol so provides and the time windows fit. However, inclusion in the study or the start of treatment does not automatically mark every previously collected value as baseline.<\/p>\n
Screening influences participant safety, recruitment quality, and the meaningfulness of the results. Risks consist primarily of unclear criteria evidence, premature examinations without consent, inconsistent documentation, and unregulated re-screening. The process must therefore be planned close to the investigator site and at the same time consistently implement the scientific requirements defined in the protocol.<\/p>\n
Full-service CROs such as Mediconomics support screening processes through the elaboration of operational protocol specifications, consent documents, training, and screening checklists. They coordinate site management, monitoring, and data management, review the documentation of relevant criteria, and support the tracking of screening failures and permissible re-screening.<\/p>\n
Is consent required prior to screening?<\/strong><\/p>\n Prior to study-specific measures, effective informed consent is fundamentally required. The specific classification of existing care data depends on the protocol and law.<\/p>\n Is a screening failure a protocol deviation?<\/strong><\/p>\n No. Not being included can be an intended result of the eligibility check. A deviation only exists if there was a deviation from the specifications.<\/p>\n May screening values be used as baseline?<\/strong><\/p>\n Yes, if the protocol so provides and the time windows as well as the methodological requirements are fulfilled.<\/p>\n Screening in clinical trials is the protocol-specified check of whether a potential participant is suitable for a specific study. It takes place after informed consent and before inclusion in the study population. Screening can include medical history, findings, laboratory values, or other examinations defined in the protocol. Procedure and prerequisites Screening does not begin with […]<\/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-6663","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\/6663","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\/6663\/revisions"}],"predecessor-version":[{"id":7483,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6663\/revisions\/7483"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6663"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6663"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory references<\/h2>\n
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