{"id":14049,"date":"2014-10-29T08:40:19","date_gmt":"2014-10-29T07:40:19","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=14049"},"modified":"2025-05-21T11:43:52","modified_gmt":"2025-05-21T09:43:52","slug":"remote-monitoring-evolution-metier-arc","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/remote-monitoring-evolution-metier-arc\/","title":{"rendered":"Remote monitoring, une \u00e9volution du m\u00e9tier d\u2019ARC?"},"content":{"rendered":"<p><span class=\"s1\"><i>Article r\u00e9dig\u00e9 par la Soci\u00e9t\u00e9 Pharmaspecific, sp\u00e9cialiste en recherche clinique<\/i><\/span><\/p>\n<p style=\"text-align: justify;\">Depuis quelques ann\u00e9es, avec l\u2019expansion du cahier \u00e9lectronique, les entreprises pharmaceutiques privil\u00e9gient de plus en plus le <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>remote monitoring<\/strong><\/a> et mettent en place des outils afin d\u2019aider l\u2019ARC \u00e0 l\u2019appliquer. Certains voient une nouvelle fa\u00e7on de cr\u00e9er une relation de confiance avec le centre investigateur en le responsabilisant d\u2019avantage sur le recueil des donn\u00e9es dont il a la charge, quand d\u2019autres ne voient qu\u2019un nouveau moyen de r\u00e9duire les co\u00fbts li\u00e9s au monitoring pour les entreprises pharmaceutiques.<\/p>\n<p style=\"text-align: justify;\"><!--more--><\/p>\n<p style=\"text-align: justify;\"><strong>Nous remercions S\u00e9verine Lopez, ARC senior, d&rsquo;avoir partag\u00e9 ses connaissances et son exp\u00e9rience avec nous, en r\u00e9digeant cet article.<\/strong><\/p>\n<h2 style=\"text-align: justify;\">Le remote monitoring\u2026\u00e7a consiste en quoi\u00a0?<\/h2>\n<p style=\"text-align: justify;\">Le remote monitoring consiste en une revue de certaines donn\u00e9es \u00e0 distance,\u00a0 cela implique bien s\u00fbr l\u2019utilisation d\u2019un CRF \u00e9lectronique (e-CRF). D\u00e8s lors que le personnel du centre a saisi les donn\u00e9es dans l&rsquo; e-CRF, l\u2019ARC v\u00e9rifie leur coh\u00e9rence et les valide en tant que \u00ab\u00a0datas reviewed\u00a0\u00bb. V\u00e9rifier la coh\u00e9rence des donn\u00e9es c\u2019est tout simplement v\u00e9rifier, par exemple, qu\u2019un patient d\u00e9fini comme \u00ab\u00a0masculin\u00a0\u00bb n\u2019a pas comme ant\u00e9c\u00e9dent m\u00e9dical une hyst\u00e9rectomie\u2026<\/p>\n<p style=\"text-align: justify;\">Cette revue se fait toutes les semaines ou d\u00e8s que les donn\u00e9es sont saisies en p\u00e9riode de s\u00e9lection des patients\u00a0afin de pouvoir identifier des possibles \u00e9checs de s\u00e9lection et surtout d&rsquo;\u00e9viter des inclus \u00e0 tort.<\/p>\n<p style=\"text-align: justify;\">Toutes les donn\u00e9es saisies dans le e-CRF sont revues dans ce sens, et certaines peuvent \u00eatre v\u00e9rifi\u00e9es par comparaison avec d\u2019autres syst\u00e8mes \u00e9lectroniques utilis\u00e9s dans le cadre de l\u2019\u00e9tude\u00a0:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Syst\u00e8me de revue des r\u00e9sultats de laboratoire (date de naissance, date de la visite, poids du patient, sexe du patient\u2026)<\/li>\n<li>Syst\u00e8me pour la dispensation du traitement \u00e0 l\u2019\u00e9tude (date de la dispensation, bras attribu\u00e9 au patient si applicable, num\u00e9ro des lots dispens\u00e9s au patient, poids du patient si applicable). Lorsqu\u2019une donn\u00e9e ne semble pas coh\u00e9rente ou est diff\u00e9rente de celle trouv\u00e9e sur un autre syst\u00e8me, une query peut alors \u00eatre \u00e9mise et permettre au Technicien d\u2019Etude Clinique (TEC) de v\u00e9rifier et corriger (ou pas) la donn\u00e9e.<\/li>\n<\/ul>\n<h2 style=\"text-align: justify;\"><img data-recalc-dims=\"1\" decoding=\"async\" class=\"size-full wp-image-14051 aligncenter lazyload\" data-src=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/e-crf.png?resize=957%2C502&#038;ssl=1\" alt=\"Le remote monitoring\" width=\"957\" height=\"502\" data-srcset=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/e-crf.png?w=957&amp;ssl=1 957w, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/e-crf.png?resize=300%2C157&amp;ssl=1 300w, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/e-crf.png?resize=768%2C403&amp;ssl=1 768w, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/e-crf.png?resize=600%2C315&amp;ssl=1 600w\" data-sizes=\"(max-width: 957px) 100vw, 957px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 957px; --smush-placeholder-aspect-ratio: 957\/502;\" \/>Et le \u00ab\u00a0vrai\u00a0\u00bb monitoring \u2026que devient-il\u00a0?<\/h2>\n<p style=\"text-align: justify;\">Le monitoring est la revue des donn\u00e9es recueillies par le centre investigateur o\u00f9 se d\u00e9roule l\u2019\u00e9tude, par comparaison entre le cahier de report des donn\u00e9es (Clinical Report Form) et les \u00ab\u00a0donn\u00e9es sources\u00a0\u00bb (dossier du patient, compte-rendu clinique, notes m\u00e9dicales\u2026). Le <strong>remote monitoring<\/strong> ne remplace pas cette partie du monitoring mais la simplifie en \u00e9liminant les erreurs de saisie bien avant la venue de l\u2019ARC sur le centre.<\/p>\n<p style=\"text-align: justify;\">Lors de son monitoring, l\u2019ARC peut donc se concentrer sur la v\u00e9rification de la v\u00e9racit\u00e9 des donn\u00e9es, et se consacrer \u00e0 d\u2019autres activit\u00e9s li\u00e9es au monitoring tel que la formation du personnel de l\u2019\u00e9tude, la revue et collecte des documents essentiels ou encore la revue des lettres de suivi des \u00e9v\u00e8nements ind\u00e9sirables graves.<\/p>\n<p style=\"text-align: justify;\">Certains protocoles \u00e9tablissent une revue focalis\u00e9e que sur certaines donn\u00e9es de l\u2019\u00e9tude (crit\u00e8res d&rsquo;\u00e9valuation, donn\u00e9es de s\u00e9curit\u00e9, crit\u00e8res d\u2019efficacit\u00e9). La revue n\u2019est donc plus sur 100% des donn\u00e9es mais que sur des donn\u00e9es dites \u00ab\u00a0cibles\u00a0\u00bb, dans ce cas on est sur du \u00ab\u00a0target source data verification\u00a0\u00bb. La revue des autres donn\u00e9es se fait alors essentiellement \u00e0 distance.<\/p>\n<h2 style=\"text-align: justify;\">\u00a0Balance B\u00e9n\u00e9fices \/ Risques du remote monitoring :<\/h2>\n<ul style=\"text-align: justify;\">\n<li>La relation promoteur-centre (ARC-TEC) est approfondie par une prise de contact plus r\u00e9guli\u00e8re.<\/li>\n<li>Le centre se responsabilise un peu plus dans la saisie des donn\u00e9es sachant qu\u2019elles vont \u00eatre v\u00e9rifi\u00e9es rapidement.<\/li>\n<li>Les erreurs rapidement identifi\u00e9es sont rapidement corrig\u00e9es et m\u00eame \u00e9vit\u00e9es lors des prochaines saisies.<\/li>\n<li>Le centre comprend mieux les attentes du promoteur quant \u00e0 cette saisie et le mode de collaboration n\u2019en est qu\u2019am\u00e9lior\u00e9.<\/li>\n<li>L\u2019ARC sait quelle type de collaboration va \u00eatre mise en place avec le centre, au vue du rythme des saisies des donn\u00e9es, de leur exactitude, il peut orienter sa collaboration en \u00e9tant plus insistant dans le suivi ou au contraire beaucoup moins.<\/li>\n<li>Les co\u00fbts sont diminu\u00e9s de part la r\u00e9duction du nombre de visites sur centre\u00a0: en effet l\u2019\u00e9quation est simple, plus de temps sur centre donc plus de donn\u00e9es revues donc moins de visites suppl\u00e9mentaires pour terminer la revue de l\u2019ensemble des donn\u00e9es.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">Le <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>remote monitoring<\/strong><\/a> est un nouveau moyen efficace de revue des donn\u00e9es \u00e0 distance. Des \u00e9tudes comparatives ont d\u00e9montr\u00e9 que le niveau de risque d\u2019erreur reste inchang\u00e9 entre un monitoring classique avec une revue de 100% des donn\u00e9es et un remote monitoring avec une v\u00e9rification de donn\u00e9es cibl\u00e9es.<\/p>\n<p style=\"text-align: justify;\">A l\u2019heure o\u00f9 toutes nos actions sont li\u00e9es \u00e0 l\u2019\u00e9lectronique et les r\u00e9seaux informatiques (courses \u00e0 distance, sport \u00e0 distance, bient\u00f4t m\u00e9decine \u00e0 distance\u2026\u00a0!) le cybermonitoring trouve toute sa place et a encore beaucoup de fa\u00e7on de se d\u00e9velopper\u00a0!<\/p>\n<p style=\"text-align: justify;\">Et toi,\u00a0est ce que tu participe\u00a0au\u00a0remote monitoring, en tant qu&rsquo;ARC ou TEC, est tu pour ou contre? Laisse nous ton avis.<\/p>\n<p style=\"text-align: justify;\"><strong>Article r\u00e9dig\u00e9 par S\u00e9verine Lopez, ARC senior.<\/strong><\/p>\n<p style=\"text-align: justify;\"><strong>Visite \u00e9galement le site internet de Pharmaspecific, <a href=\"http:\/\/pharmaspecific.com\/\">www.pharmaspecific.com<\/a>\u00a0et d\u00e9couvre nos activit\u00e9s.<\/strong><\/p>\n<p style=\"text-align: justify;\"><em>Si tu as aim\u00e9 cet article, je te remercie de \u00ab\u00a0liker\u00a0\u00bb ou de partager avec tes coll\u00e8gues et amis attach\u00e9s de <strong>recherche clinique<\/strong> et chefs de projet. Tu peux te rendre sur la page Facebook du \u00ab\u00a0blog de la recherche clinique\u00a0\u00bb et de \u00ab\u00a0Pharmaspecific\u00a0\u00bb et cliquer sur \u00ab\u00a0j\u2019aime\u00a0\u00bb pour nous soutenir. Tu peux \u00e9galement t&rsquo;inscrire \u00e0 la newsletter du blog, nous t&rsquo;informerons des nouveaux articles d\u00e8s qu&rsquo;ils seront post\u00e9s.<\/em><\/p>\n<hr \/>\n<p class=\"p1\" style=\"text-align: center;\"><span class=\"s1\"><b><i>Vous avez besoin d\u2019une prestation en recherche clinique? contactez PHARMASPECIFIC en vous rendant sur notre site en cliquant ici : <\/i><\/b><a href=\"https:\/\/pharmaspecific.com\/devis\"><span class=\"s2\"><b><i>https:\/\/pharmaspecific.com\/devis<\/i><\/b><\/span><\/a><\/span><\/p>\n<p class=\"p1\" style=\"text-align: center;\"><span class=\"s1\"><i>Si tu as des questions sur le m\u00e9tier d\u2019attach\u00e9 de recherche clinique ou sur une carri\u00e8re dans la recherche clinique, tu peux la mettre dans les commentaires ci-dessous. Nous te r\u00e9pondrons dans les plus brefs d\u00e9lais.<\/i><\/span><\/p>\n<p class=\"p1\" style=\"text-align: center;\"><span class=\"s1\"><i>Si tu veux \u00eatre coach\u00e9, si tu veux une r\u00e9ponse personnalis\u00e9e \u00e0 tes questions ou \u00eatre en contact avec d\u2019autres professionnels de la recherche clinique, tu peux te rendre sur <\/i><a href=\"https:\/\/pharmaspecific-training.com\/\"><span class=\"s2\"><i>https:\/\/pharmaspecific-training.com\/<\/i><\/span><\/a><\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>Le remote monitoring consiste en une revue de certaines donn\u00e9es \u00e0 distance,\u00a0 cela implique bien s\u00fbr l\u2019utilisation d\u2019un CRF \u00e9lectronique (e-CRF). D\u00e8s lors que le personnel du centre a saisi les donn\u00e9es dans l&rsquo; e-CRF, l\u2019ARC v\u00e9rifie leur coh\u00e9rence et les valide en tant que \u00ab\u00a0datas reviewed\u00a0\u00bb.<\/p>","protected":false},"author":4,"featured_media":14051,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":{"facebook_122143508198123560_331463380343150":""},"rop_publish_now_history":[],"rop_publish_now_status":"pending","_sitemap_exclude":false,"_sitemap_priority":"","_sitemap_frequency":"","_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[454],"tags":[16,80,66,123,82,124],"class_list":{"0":"post-14049","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-strategie-devolution-pour-atteindre-vos-objectifs","8":"tag-arc","9":"tag-arc-evolution","10":"tag-attache-de-recherche-clinique","11":"tag-monitoring-a-distance","12":"tag-poste-attache-de-recherche-clinique","13":"tag-remote-monitoring"},"translation":{"provider":"WPGlobus","version":"3.0.2","language":"en","enabled_languages":["fr","en"],"languages":{"fr":{"title":true,"content":true,"excerpt":true},"en":{"title":false,"content":false,"excerpt":false}}},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Remote monitoring, une \u00e9volution du m\u00e9tier d\u2019ARC?<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blogdelarechercheclinique.com\/en\/remote-monitoring-evolution-metier-arc\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Remote monitoring, une \u00e9volution du m\u00e9tier d\u2019ARC? 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Est-ce que ce serait adapt\u00e9 pour moi? Pouvez-vous me donner votre avis sur les points que j\u2019ai \u00e9voqu\u00e9s?","rel":"","context":"In &quot;Jeux - \u00e9v\u00e8nements&quot;","block_context":{"text":"Jeux - \u00e9v\u00e8nements","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/jeux-evenements\/"},"img":{"alt_text":"Remote monitoring","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2017\/02\/remote-monitoring.png?fit=823%2C471&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2017\/02\/remote-monitoring.png?fit=823%2C471&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2017\/02\/remote-monitoring.png?fit=823%2C471&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2017\/02\/remote-monitoring.png?fit=823%2C471&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":14016,"url":"https:\/\/blogdelarechercheclinique.com\/en\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/","url_meta":{"origin":14049,"position":2},"title":"Le Risk-based monitoring, une nouvelle approche du contr\u00f4le qualit\u00e9","author":"Vanessa Montanari","date":"24 March 2015","format":false,"excerpt":"Depuis quelques ann\u00e9es, nous assistons \u00e0 un v\u00e9ritable changement concernant la fa\u00e7on de r\u00e9aliser le monitoring d\u2019un essai clinique, et ce, \u00e0 l\u2019\u00e9chelle internationale. 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Once the center's staff entered the data in the e-CRF, the CRA checks their consistency and valid them as \"data reviewed.\"","rel":"","context":"In &quot;Strat\u00e9gie d'\u00e9volution pour atteindre vos objectifs&quot;","block_context":{"text":"Strat\u00e9gie d'\u00e9volution pour atteindre vos objectifs","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/strategie-devolution-pour-atteindre-vos-objectifs\/"},"img":{"alt_text":"Le remote monitoring","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/e-crf.png?fit=957%2C502&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/e-crf.png?fit=957%2C502&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/e-crf.png?fit=957%2C502&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/e-crf.png?fit=957%2C502&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":706,"url":"https:\/\/blogdelarechercheclinique.com\/en\/savoir-choisir-arc-tec\/","url_meta":{"origin":14049,"position":4},"title":"ARC &#8211; TEC: conseils importants pour choisir son emploi","author":"Vanessa Montanari","date":"7 April 2015","format":false,"excerpt":"Dans cet article, nous allons t\u2019aider dans ton choix en te pr\u00e9sentant chaque type de poste, ses missions, les structures dans lesquelles postuler et les perspectives d\u2019\u00e9volution.","rel":"","context":"In &quot;Trouver un emploi en recherche clinique&quot;","block_context":{"text":"Trouver un emploi en recherche clinique","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/trouver-un-emploi-en-recherche-clinique\/"},"img":{"alt_text":"Comment bien choisir son post?","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2015\/04\/choisir.png?fit=1022%2C677&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2015\/04\/choisir.png?fit=1022%2C677&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2015\/04\/choisir.png?fit=1022%2C677&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2015\/04\/choisir.png?fit=1022%2C677&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":14034,"url":"https:\/\/blogdelarechercheclinique.com\/en\/metier-arc-evolution-vanessa-montanari\/","url_meta":{"origin":14049,"position":5},"title":"Evoluer rapidement dans le m\u00e9tier d&rsquo;ARC","author":"Vanessa Montanari","date":"26 November 2014","format":false,"excerpt":"D\u00e9couvre comment faire une \u00e9volution rapide dans le m\u00e9tier d'ARC. 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