{"id":6963,"date":"2026-04-01T11:16:55","date_gmt":"2026-04-01T09:16:55","guid":{"rendered":"https:\/\/mediconomics.com\/?post_type=glossary&#038;p=6963"},"modified":"2026-07-13T19:09:31","modified_gmt":"2026-07-13T17:09:31","slug":"first-patient-first-visit-fpfv","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/first-patient-first-visit-fpfv\/","title":{"rendered":"First Patient First Visit (FPFV)"},"content":{"rendered":"<p>First Patient First Visit (FPFV) refers, in clinical trials, to the point in time at which the first study participant completes their first study-related visit at the investigational site, marking the start of actual data collection. The event marks the transition from study preparation (study start-up) to conduct and is often used as an operational milestone in project plans, KPIs and contracts between the sponsor and the Contract Research Organization.<\/p>\n<h2>What exactly counts as First Patient First Visit?<\/h2>\n<p>For the definition, it is decisive that the visit is study-related and takes place after clearance of the relevant prerequisites. Typically, FPFV occurs after approval by the ethics committee and authority, after contract conclusion with the investigational site, and after a successful Site Initiation Visit. In practice, FPFV is often confused with the first visit after randomisation; depending on the study protocol, however, the first visit may also be a baseline or screening visit.<\/p>\n<ul>\n<li><strong>Screening-based definition:<\/strong> FPFV is the first visit defined as screening in the study protocol.<\/li>\n<li><strong>Baseline-based definition:<\/strong> FPFV is the first visit after confirmed eligibility.<\/li>\n<li><strong>Intervention-based definition:<\/strong> FPFV is the first visit at which the first administration\/application takes place (e.g. IMP administration or device application).<\/li>\n<\/ul>\n<p>Which definition applies should be clearly set out in the clinical study protocol, the monitoring plan and study reporting, as different timelines and performance indicators result from this.<\/p>\n<h2>Prerequisites and typical dependencies before FPFV<\/h2>\n<p>For FPFV to be achieved, key documents, systems and processes must be in an auditable state. These include, among others, site activation, trained staff, availability of the investigational medicinal product, and a functioning data management set-up (e.g. Electronic Data Capture and Electronic Case Report Form). In multicentre trials, an early FPFV can be planned at a lead site to test procedures before further sites are activated.<\/p>\n<ul>\n<li>Final versions of the ICF\/patient information, including local requirements and translations<\/li>\n<li>Training on SOPs, protocol and safety reporting (including reporting pathways for serious adverse events)<\/li>\n<li>Logistics: shipment, storage, temperature monitoring and accountability of the investigational medicinal product<\/li>\n<li>Release of critical systems (e.g. randomisation, IRT\/IXRS, database, audit trail)<\/li>\n<\/ul>\n<p>A common stumbling block is that documents formally exist but are not operationally embedded, for example when delegation logs are incomplete or EDC roles have not been correctly assigned. Such errors increase the risk of deviations already at the first visits.<\/p>\n<h2>Why FPFV is a central KPI<\/h2>\n<p>FPFV is an indicator of whether planning and site readiness were realistic. Many sponsors manage their clinical programmes based on time to FPFV, since delays frequently continue to affect recruitment and timeline management. In study economics, FPFV often marks the start of cost-intensive phases: monitoring activities begin, screening and laboratory costs are incurred, and data entry in the EDC generates ongoing effort.<\/p>\n<p>In reporting, FPFV is often considered together with First Patient In (FPI) and First Patient First Dose. Depending on the study design, FPFV can occur close in time to FPI or considerably later, for example when several examinations take place between consent and baseline. For a robust interpretation, the sponsor and CRO should use shared definitions and document these in the Trial Master File.<\/p>\n<h2>Relevance for clinical trials (CRO and sponsor perspective)<\/h2>\n<p>From a CRO perspective, FPFV is the moment at which the quality of preparation proves itself in practice. A well-prepared FPFV reduces protocol deviations, minimises query volume in data management, and improves the likelihood that subsequent sites can be activated quickly following the same pattern. Full-service CROs such as mediconomics typically provide support here with study start-up, site management, training, monitoring set-up, and coordination between data management, pharmacovigilance and project management.<\/p>\n<p>For sponsors, FPFV is also regulatorily relevant, because from this point onward study-specific data are generated that must be described plausibly and traceably in the Clinical Study Report. In addition, FPFV can serve as a reference point during audits and inspections, from which point processes had to be effective, e.g. in relation to consent, documentation obligations and safety monitoring. Traceability of the preparation steps in the TMF is therefore important.<\/p>\n<h2>Frequently asked questions (FAQ)<\/h2>\n<h3>Is First Patient First Visit the same as First Patient In?<\/h3>\n<p>No. First Patient In often refers to the point of consent or the first contact within screening, while FPFV refers to the first study-related visit according to the study protocol. In many trials, both points in time are close together, but they can differ considerably depending on the protocol.<\/p>\n<h3>Which documents should be particularly checked around FPFV?<\/h3>\n<p>Typical documents are the correct version of the patient information and consent, delegation and training logs, IMP accountability records, and system approvals (EDC, randomisation, audit trail). In addition, reporting pathways for safety-relevant events should be operationally tested.<\/p>\n<h3>How is FPFV meaningfully used in project controlling?<\/h3>\n<p>FPFV is suitable as a starting point for conduct KPIs such as recruitment rate, data-entry latency and monitoring frequency. For the metric to be manageable, the definition, data source and responsibilities (sponsor vs. CRO) must be established before study start.<\/p>\n<h2>Regulatory references<\/h2>\n<ul>\n<li>ICH E6(R3) Good Clinical Practice: requirements for study organisation, documentation and quality systems during conduct.<\/li>\n<li>Regulation (EU) No 536\/2014 (Clinical Trials Regulation): requirements for approval, conduct and transparency of clinical trials in the EU.<\/li>\n<li>EU GMP Guide Annex 13 (Investigational Medicinal Products): expectations for labelling, storage and responsibilities for the Investigational Medicinal Product in clinical trials.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>First Patient First Visit (FPFV) refers, in clinical trials, to the point in time at which the first study participant completes their first study-related visit at the investigational site, marking the start of actual data collection. The event marks the transition from study preparation (study start-up) to conduct and is often used as an operational [&hellip;]<\/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-6963","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\/6963","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\/6963\/revisions"}],"predecessor-version":[{"id":6965,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6963\/revisions\/6965"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6963"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6963"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}