Last Patient Last Visit (LPLV) refers, in clinical trials, to the point in time at which the last enrolled study participant has completed their final protocol-specified visit. The milestone marks the end of patient-related data collection and initiates the phase of data cleaning, analysis and report writing. LPLV is a central project management milestone, because it forms the basis for downstream steps such as database lock and the Clinical Study Report.<\/p>\n
LPLV is sometimes confused with Last Patient In (LPI) or End of Treatment (EOT). LPLV, however, refers explicitly to the last scheduled visit of the last patient and thus depends on the follow-up duration defined in the clinical study protocol. In trials with long-term follow-up, a considerable amount of time can elapse between the last treatment and LPLV, for example in the case of safety follow-up or efficacy endpoints such as overall survival.<\/p>\n
For trials with early discontinuations, it must be defined whether an early termination visit counts as the “last visit”. It is common practice that LPLV is only reached once the last patient has completed the last required visit, regardless of whether other patients discontinued earlier.<\/p>\n
For LPLV to be reached as planned, recruitment, retention and visit compliance must be managed stably throughout the entire trial duration. Typical risks are drop-outs, protocol deviations, rescheduled appointments, or incomplete examinations that lead to additional visits. From a monitoring perspective, it is particularly important, before LPLV, that outstanding queries, missing documents and open safety reports are addressed in good time.<\/p>\n
In multicentre trials, sites can progress at different speeds. A common misconception is that LPLV is reached as soon as the “last active site” has finished. What matters, however, is the last patient across all sites. Consistent tracking via EDC, enrolment reports and site status overviews is therefore required for control purposes.<\/p>\n
After LPLV, the intensive phase of data cleaning typically begins: query management, source data verification for critical data points, review of protocol deviations, and the final coding of events (e.g. according to MedDRA). At the same time, data management and biostatistics are closely coordinated to implement the Statistical Analysis Plan and finalise the analysis populations.<\/p>\n
LPLV is often the starting point for time-defined process steps, such as “X days after LPLV” until database lock or until final data handover. These time windows must be planned realistically, since late or incomplete data can lead to rework. In practice, a clear data cut plan that specifies which data must be complete by when is helpful.<\/p>\n
An additional practical aspect is the so-called visit window management: many protocols allow a time window for the final follow-up visit (e.g. +\/-7 days). For LPLV, it is then not the planned target date that counts, but the visit actually conducted within the window. Project teams should therefore actively monitor the visit window and take corrective action early if the last patient is moving towards falling “outside the window”.<\/p>\n
In addition, LPLV often depends on the completeness of external data. Central laboratories, imaging assessment (core lab), or Patient-Reported Outcome systems sometimes deliver results with a time lag. If such data only arrive after the last on-site visit, it must be clear whether they are part of the final data collection or are planned as a downstream data flow within the lock plan. A coordinated reconciliation approach between EDC and the safety database reduces the risk of inconsistent endpoints here.<\/p>\n
For sponsors, LPLV is the moment from which the preparation of core documents can be prioritised in medical writing planning. This includes tables, listings and figures, the structure of the Clinical Study Report, and coordination with Regulatory Affairs teams, particularly where marketing authorisation strategies or publication plans are pending. At the same time, it must be ensured that the Trial Master File is complete, because audits and inspections can also take place after the end of the trial.<\/p>\n
From a CRO perspective, LPLV is a performance milestone that shows whether recruitment, monitoring and data management ran stably throughout the trial cycle. Full-service CROs such as mediconomics typically provide support through central project controlling, monitoring coordination, database review and preparation of the database lock. A clean LPLV process reduces later delays in analysis and reporting.<\/p>\n
LPLV marks the end of the data collection specified in the study protocol. Only after this point is it clear that all follow-up data required for endpoints and safety assessments are available.<\/p>\n
Common steps are final data cleaning, the closing of queries, final coding, review of protocol deviations, and preparation of the database lock. Structured CSR preparation frequently starts in parallel.<\/p>\n
Many authorisation and submission activities depend on the availability of final analyses and reports. If LPLV occurs later, the database lock usually shifts as well, and with it the point at which a robust Clinical Study Report is available for submissions.<\/p>\n
Last Patient Last Visit (LPLV) refers, in clinical trials, to the point in time at which the last enrolled study participant has completed their final protocol-specified visit. The milestone marks the end of patient-related data collection and initiates the phase of data cleaning, analysis and report writing. LPLV is a central project management milestone, because […]<\/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":"set","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-6914","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\/6914","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\/6914\/revisions"}],"predecessor-version":[{"id":6917,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6914\/revisions\/6917"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6914"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6914"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}