A temporary halt is an interruption of the clinical trial by the sponsor that is not foreseen in the protocol, with the intention to resume. It may affect individual activities such as recruitment or treatment, or the entire conduct. The legal classification determines notification, follow-up, resumption, and the relationship to definitive termination. <\/p>\n
The interruption may be triggered by unexpected circumstances, regardless of whether the benefit-risk assessment is affected. During the interruption, safety issues must be evaluated and participants must continue to be monitored as necessary. If safety, lack of efficacy, or a quality defect of an investigational medicinal product is the reason, a substantial modification with justification, analysis, mitigation measures where applicable, and an updated benefit-risk assessment is required for resumption. <\/p>\n
For a temporary halt, notification to the affected Member States is required without undue delay and at the latest within 15 days. If the reason does not affect the benefit-risk assessment, such as a supply shortage, resumption is notified within 15 days after restart. If the trial is not resumed within two years, the expiry of this period or the sponsor’s earlier decision not to continue is considered the end date of the trial. <\/p>\n
The interruption requires ongoing management. Information to sites must clearly specify which measures are stopped, which follow-up continues, and which data may be collected. In case of prolonged interruption, expiry, supply, contractual situation, staff changes, and the currency of documents must also be reviewed. Restart may only take place once the documented conditions are met and the sites are prepared and operational. <\/p>\n
The distinction is also relevant for results reporting. Following early termination, the available results must generally be treated differently than in the case of a temporary pause with ongoing resumption planning. The sponsor should therefore document the transition to definitive end as a deliberate, justified decision and not derive the required notifications solely from operational status lists. <\/p>\n
The temporary halt is initiated by the sponsor and pursues the intention to resume. This differs from suspension: it is an interruption by a Member State that may take corrective measures under Article 77 when requirements of the Regulation are no longer met. A sponsor interruption must therefore not be designated as a regulatory suspension. <\/p>\n
Definitive termination or early termination ends the trial before fulfillment of the conditions specified in the protocol. Unlike the temporary halt, there is no intention to resume. If an interruption is not resumed within two years or if the sponsor decides earlier against continuation, it is legally treated as the end of the trial. The entry study termination thus designates a different final state. <\/p>\n
The status of the trial should be maintained consistently in CTIS, in the protocol, in site instructions, and in internal status reports. Particularly in the case of only partial interruption, it must be recorded whether recruitment, treatment, follow-up, or data queries are affected. Participants must not be left between interruption and aftercare without clear information. The sponsor must therefore plan the required medical care, the handling of remaining investigational medicinal products, and the communication of new safety information. Resumption requires more than lifting a notification: sites need confirmed approvals, current documents, trained personnel, and verified supply or system readiness. If continuation is no longer justifiable or not planned, the transition to early termination must be actively decided. This discipline prevents an apparently provisional pause from becoming a de facto uncontrolled study end. <\/p>\n
The chronological sequence of notifications, safety assessments, and site instructions should be fully documented. It demonstrates that the interruption was actively managed and that no gap in care arose for participants. In the event of later resumption, it also forms the basis for a traceable release decision. <\/p>\n
The related term study termination describes definitive termination. The temporary halt may only be maintained as such as long as the intention to resume exists and the legal prerequisites for continuation or restart are actively pursued. <\/p>\n
The designation of the measure must be clear in the project, as it determines the correct regulatory pathways and site instructions. Unplanned pauses without documented intention to resume can lead to contradictory information about recruitment, follow-up, and medicinal product supply. In the case of safety reasons, updating the benefit-risk assessment is not deferrable; in the case of non-safety-related reasons, participant care must nevertheless continue in a controlled manner. <\/p>\n
Full-service CROs such as Mediconomics support situation assessment, CTIS notifications, site information, and follow-up planning. They coordinate substantial modifications for restart, review study documents, and document decisions regarding interruption, resumption, or early termination in quality management. <\/p>\n
Is a recruitment stop always a temporary halt?<\/strong><\/p>\n It may fall under this category if the sponsor initiates an interruption not foreseen in the protocol with the intention to resume. The specific scope must be documented. <\/p>\n When is a substantial modification required for restart?<\/strong><\/p>\n When the interruption occurred for safety reasons, due to lack of efficacy, or a quality defect, and the benefit-risk assessment is affected.<\/p>\n When does the interruption become the end of the trial?<\/strong><\/p>\n When it is not resumed within two years or when the sponsor decides beforehand not to continue the trial.<\/p>\n A temporary halt is an interruption of the clinical trial by the sponsor that is not foreseen in the protocol, with the intention to resume. It may affect individual activities such as recruitment or treatment, or the entire conduct. The legal classification determines notification, follow-up, resumption, and the relationship to definitive termination. Prerequisites and Scope […]<\/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":[21],"class_list":["post-7865","glossary","type-glossary","status-publish","hentry","glossary-cat-clinical-operations-gcp"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7865","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\/7865\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7865"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7865"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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