The Data Lock Point is the designated cut-off date for a reporting interval, up to which safety data must be included in a periodic safety report. In the European PSUR context, it serves as Day 0 for calculating the submission deadline, thereby delimiting the analyzed dataset of a periodic report without halting the ongoing safety process.<\/p>\n
The Data Lock Point determines the period covered by the benefit-risk evaluation of the PSUR. GVP Module VII requires that the report be based on all available data and focus on new information since the Data Lock Point of the previous PSUR. Cumulative data are nevertheless utilized for the overarching safety assessment and the integrated benefit-risk evaluation.<\/p>\n
This delimitation affects numerous sections of a PSUR. Clinical trial data may show cumulative exposure from the Development International Birth Date up to the Data Lock Point. For the post-authorization period, cumulative and interval-based exposure data, as well as adverse reaction summaries, are considered up to the Data Lock Point. The status of a signal is also referenced to this point in time: a matter still under review is ongoing at the Data Lock Point, while a matter concluded before then is closed.<\/p>\n
New important findings may arrive during the preparation phase. These are not rendered invisible simply because they occur after the Data Lock Point. GVP Module VII provides for potentially important safety, efficacy, or effectiveness information to be presented as late-breaking information. This maintains the temporal comparability of the report without concealing relevant subsequent developments.<\/p>\n
For PSUR reporting intervals up to and including twelve months, GVP Module VII specifies submission within 70 calendar days after the Data Lock Point. For intervals exceeding twelve months, the deadline is 90 calendar days. In both cases, the Data Lock Point is designated as Day 0 of the submission deadline.<\/p>\n
For an ad hoc PSUR requested by a competent authority, the request usually determines the deadline. In the absence of such a specification, GVP Module VII provides for submission within 90 calendar days after the Data Lock Point. The specific frequency and respective cut-off date can be established or adjusted in the EU reference date list; the intended responsibilities of the CHMP, CMDh, and PRAC must be observed.<\/p>\n
The term Day 0 thus has a different practical function in the PSUR context than the Day 0 of an expedited individual case safety report. For an individual case, the clock starts upon receipt of a qualified report by the marketing authorization holder. In contrast, for the Data Lock Point, it is linked to the conclusion of a predefined reporting interval. The use of the same designation for a start date must not lead to the mixing of these two deadline regimes.<\/p>\n
The Data Lock Point is distinct from the database lock of a clinical trial. Database lock marks the operational point in time at which trial data are fixed for analysis following cleaned queries and defined checks. It belongs to the data management and analysis planning of a specific study.<\/p>\n
The Data Lock Point of the PSUR has a different scope. It organizes safety-relevant information for a medicinal product over a reporting interval, including data from various sources and, if applicable, multiple studies. A PSUR can therefore consider information from a still ongoing study up to its Data Lock Point without the study database having to be closed.<\/p>\n
The existing entry for database lock describes the study conclusion at the data level. Data Lock Point, however, determines the temporal boundary of the periodic medicinal product safety evaluation. If the terms are confused, the reporting team and study management may incorrectly assume that a full study conclusion must be awaited before a PSUR can be completed.<\/p>\n
Study teams provide exposure, serious events, safety analyses, and information on ongoing signals up to the specified Data Lock Point for a PSUR. To achieve this, data management, clinical project management, and pharmacovigilance must clarify early which data extractions and medical reviews will be available in time. Significant results arriving subsequently require a transparent classification as post-DLP information, rather than being tacitly included in the closed interval.<\/p>\n
Full-service CROs like Mediconomics support work related to the Data Lock Point through schedules for data retrieval, reconciliation of safety listings and exposure data, coordination of clinical reviews, and the preparation of contributions for the PSUR. Medical Writing and Pharmacovigilance can also document which data were available at the cut-off date, how ongoing signals were evaluated, and which late-received information must be considered separately.<\/p>\n
Must important information received after the Data Lock Point be ignored?<\/strong><\/p>\n No. It does not retroactively change the defined reporting period, but it can be summarized as late-breaking information in the PSUR if it is significant for safety, efficacy, or effectiveness.<\/p>\n Does the same 70-day deadline apply to every PSUR?<\/strong><\/p>\n No. The 70-calendar-day deadline applies to reporting intervals up to and including twelve months. For longer intervals, GVP Module VII specifies 90 calendar days after the Data Lock Point.<\/p>\n Can the Data Lock Point occur before a study’s database lock?<\/strong><\/p>\n Yes. The PSUR Data Lock Point delimits the periodic safety evaluation of a medicinal product. It does not require a database lock of the individual study from which safety information may originate.<\/p>\n The Data Lock Point is the designated cut-off date for a reporting interval, up to which safety data must be included in a periodic safety report. In the European PSUR context, it serves as Day 0 for calculating the submission deadline, thereby delimiting the analyzed dataset of a periodic report without halting the ongoing safety […]<\/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-8073","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\/8073","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\/8073\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=8073"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=8073"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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