{"id":14016,"date":"2015-03-24T22:21:23","date_gmt":"2015-03-24T21:21:23","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=14016"},"modified":"2025-05-21T11:39:39","modified_gmt":"2025-05-21T09:39:39","slug":"le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/","title":{"rendered":"Le Risk-based monitoring, une nouvelle approche du contr\u00f4le qualit\u00e9"},"content":{"rendered":"

Article r\u00e9dig\u00e9 par la Soci\u00e9t\u00e9 Pharmaspecific, sp\u00e9cialiste en recherche clinique<\/i><\/span><\/p>\n

Le Risk-based monitoring, une nouvelle approche du contr\u00f4le qualit\u00e9<\/strong><\/p>\n

Depuis quelques ann\u00e9es, nous assistons \u00e0 un v\u00e9ritable changement concernant la fa\u00e7on de r\u00e9aliser le monitoring d\u2019un<\/a> essai clinique<\/strong>, et ce, \u00e0 l\u2019\u00e9chelle internationale.
\nEn effet, une nouvelle approche fond\u00e9e sur le risque a \u00e9t\u00e9 int\u00e9gr\u00e9e dans les Bonnes Pratiques Cliniques<\/a> (BPC\u00a0; ICH GCP, section 5.1) et dans la Directive Europ\u00e9enne 2005\/28\/EC<\/a>.\u00a0On parle de \u00ab\u00a0Monitoring des essais cliniques adapt\u00e9 au risque\u00a0\u00bb (ou \u00ab\u00a0Risk-based monitoring\u00a0\u00bb, en anglais).<\/p>\n

Dans cet article, nous te proposons de t\u2019expliquer cette notion qui peut para\u00eetre un peu compliqu\u00e9e de prime abord.<\/p>\n

<\/p>\n

1.\u00a0Contexte r\u00e8glementaire<\/strong><\/h2>\n

En Europe, les BPC se sont impos\u00e9es \u00e0 l\u2019ensemble des essais cliniques portant sur un m\u00e9dicament \u00e0 usage humain par les directives europ\u00e9ennes 2001\/20\/CE et 2005\/28\/CE (les BPC ont \u00e9t\u00e9 transpos\u00e9es dans le droit fran\u00e7ais par la d\u00e9cision du 24 novembre 2006). Elles y int\u00e8grent de nombreuses notions, dont celle du monitoring.<\/p>\n

D\u00e9finition du monitoring<\/span> (issue de la D\u00e9cision du 24 Novembre 2006)\u00a0: \u00ab\u00a0 Activit\u00e9 consistant \u00e0 surveiller le d\u00e9roulement d\u2019une recherche biom\u00e9dicale et \u00e0 s\u2019assurer qu\u2019elle est conduite et que les donn\u00e9es sont recueillies et rapport\u00e9es conform\u00e9ment au protocole, aux proc\u00e9dures op\u00e9ratoires standardis\u00e9es, aux BPCs et aux dispositions l\u00e9gislatives et r\u00e9glementaires en vigueur<\/em>\u00a0\u00bb<\/pre>\n
Le monitoring de la totalit\u00e9 des dossiers sources sur site a longtemps \u00e9t\u00e9 consid\u00e9r\u00e9 comme l\u2019approche standard, appliqu\u00e9e par les ARCs. Mais depuis quelques ann\u00e9es, une nouvelle tendance se dessine.<\/p>\n
En effet en 2013, la FDA (Food and Drug Administration<\/em>) et l\u2019EMA (European Medicines Agency<\/em>) ont publi\u00e9 respectivement un guide (\u00ab\u00a0Oversight of clinical investigations – a risk based approach to monitoring<\/em>\u00a0<\/a>\u00bb et \u00ab\u00a0Electronic source data in clinical investigations<\/em>\u00a0<\/a>\u00bb) et un texte de r\u00e9flexion (\u00ab\u00a0Reflection paper on risk based quality management in clinical trials\u00a0<\/em>\u00bb, t\u00e9l\u00e9chargeable ici<\/a>), encourageant les industries pharmaceutiques \u00e0 consid\u00e9rer une nouvelle approche de monitoring, le \u00ab\u00a0Risk-based monitoring\u00a0\u00bb (RBM).<\/p>\n
Cette approche a \u00e9t\u00e9 cr\u00e9\u00e9e suite \u00e0 des d\u00e9faillances significatives dans la surveillance des essais cliniques malgr\u00e9 100% de SDV (Source Data Verification = V\u00e9rification des donn\u00e9es sources) sur site. La FDA et l\u2019EMA ont donc recommand\u00e9 une approche plus centralis\u00e9e du monitoring, comprenant de nombreux indicateurs de performance pour identifier les probl\u00e8mes sur le site de recherche, et pour limiter la quantit\u00e9 de SDV effectu\u00e9e.<\/p>\n
Le RBM int\u00e8gre donc la notion de risque, encouru par le participant, et consiste \u00e0 adapter le rythme des visites de monitoring\u00a0de l\u2019ARC en fonction de ce risque.<\/p>\n
\"Risk-based2. Le monitoring adapt\u00e9 au risque (Risk Based Monitoring, RBM), en quoi cela consiste-il\u00a0?<\/strong><\/h2>\n
Contrairement au monitoring \u00ab\u00a0standard\u00a0\u00bb qui consiste \u00e0 v\u00e9rifier 100 % des donn\u00e9es sources et \u00e0 identifier les erreurs de transcription de donn\u00e9es sources dans le CRF papier ou \u00e9lectronique, le Monitoring adapt\u00e9 au risque\u00a0(RBM) souhaite optimiser et all\u00e9ger le monitoring.<\/p>\n
L\u2019intensit\u00e9 de la v\u00e9rification des donn\u00e9es sur site sera donc adapt\u00e9e au niveau de risque, pr\u00e9\u00e9tabli d\u00e8s le d\u00e9but de l\u2019\u00e9tude dans le \u00ab\u00a0Risk management plan\u00a0\u00bb. Cela permettra entre autres d\u2019optimiser le monitoring sur site, donc de r\u00e9duire le temps pass\u00e9 dans le centre, et en cons\u00e9quence, le co\u00fbt allou\u00e9 au monitoring (pr\u00e8s de 30% du budget d\u2019une \u00e9tude est consacr\u00e9 au monitoring\u00a0!).
\nCela passe notamment par du \u00ab\u00a0Remote monitoring\u00a0\u00bb (un article a \u00e9t\u00e9 r\u00e9dig\u00e9 \u00e0 ce sujet, tu peux le consulter \u00e0 nouveau sur le blog en cliquant sur ce lien\u00a0: https:\/\/blogdelarechercheclinique.com\/remote-monitoring\/<\/a>).<\/p>\n
A noter que les v\u00e9rifications des consentements, des crit\u00e8res d\u2019\u00e9ligibilit\u00e9, et des donn\u00e9es de s\u00e9curit\u00e9 (EIG) restent inchang\u00e9es lors des monitorings sur site.<\/p>\n
Dans son guide, la FDA encourage les promoteurs \u00e0 \u00ab effectuer des analyses statistiques globales de donn\u00e9es de l’\u00e9tude pour identifier les sites qui sont aberrants par rapport aux autres\u00a0\u00bb. Autrement dit, le promoteur peut identifier les centres dont les donn\u00e9es diff\u00e8rent consid\u00e9rablement des autres gr\u00e2ce \u00e0 des algorithmes statistiques. Le promoteur va chercher \u00e0 d\u00e9tecter une information incompatible g\u00e9n\u00e9r\u00e9 par un centre, par rapport aux donn\u00e9es produites par l\u2019ensemble des autres sites participant \u00e0 l\u2019essai clinique<\/strong>.<\/p>\n
Par exemple, si un centre fait les m\u00eames erreurs sur plusieurs patients inclus ou, lorsqu\u2019au contraire, un centre ne fait jamais d\u2019erreur, le promoteur doit \u00eatre capable de l\u2019identifier gr\u00e2ce \u00e0 son logiciel. Ainsi, le promoteur \u00e9value la coh\u00e9rence des donn\u00e9es de chaque centre et d\u00e9tecte les donn\u00e9es anormales pour identifier les probl\u00e8mes sp\u00e9cifiques de chaque centre.
\nEn identifiant ainsi les \u00e9carts de donn\u00e9es, le promoteur pourra d\u00e9clencher une visite de monitoring sur site, ou bien orienter l\u2019ARC sur tels ou tels points \u00e0 v\u00e9rifier lors de sa prochaine visite sur site.<\/p>\n
Pr\u00e9venir et identifier les risques (d\u00e9tection des erreurs, laisser-aller, fraude, falsification) le plus t\u00f4t possible gr\u00e2ce aux statistiques permet d\u2019anticiper et de corriger le probl\u00e8me avant qu\u2019il ne s\u2019aggrave.<\/p>\n
3. L\u2019application du RBM dans l\u2019AP-HP (Assistance Publique – H\u00f4pitaux de Paris)<\/strong><\/h2>\n
Depuis 2003, l\u2019AP-HP applique le Risk-based monitoring, selon le type d\u2019essai clinique (avec ou sans m\u00e9dicaments) et selon la phase de l\u2019\u00e9tude concern\u00e9e, notamment pour des raisons budg\u00e9taires.<\/p>\n
Clique ici<\/span><\/a>, Tu trouveras\u00a0dans le lien suivant\u00a03 grilles qu\u2019utilisent\u00a0l\u2019AP-HP<\/a> pour d\u00e9finir le niveau de monitoring\u00a0(A, B, C, ou D\u00a0; D \u00e9tant le niveau le plus \u00e9lev\u00e9) d\u2019un essai clinique (Cf. diapos 13, 15 et 16).<\/p>\n
4. Comp\u00e9tences requises pour l\u2019ARC<\/strong><\/h2>\n
Dans le RBM, l\u2019ARC int\u00e9grera l\u2019examen de la qualit\u00e9 des donn\u00e9es dans son ensemble. Pour cela, l\u2019ARC devra am\u00e9liorer et\/ou renforcer certaines de ses comp\u00e9tences\u00a0:
\n– Utiliser des logiciels statistiques afin d\u2019identifier les \u00e9carts de donn\u00e9es\u00a0;
\n– Interpr\u00e9ter ces \u00e9carts, c\u2019est-\u00e0-dire, avoir une vue d\u2019ensemble sur les donn\u00e9es de l\u2019\u00e9tude\u00a0: \u00e9valuer l\u2019ensemble des donn\u00e9es d\u2019un site, par rapport \u00e0 celles des autres sites afin de voir si des erreurs sont r\u00e9currentes, et donc les corriger au plus vite.
\n– Effectuer du monitoring \u00e0 distance (par t\u00e9l\u00e9phone, remote monitoring, …)
\n– R\u00e9diger des outils d\u2019aide \u00e0 la prise de d\u00e9cision en fonction des types de risque
\n– R\u00e9diger un \u00ab\u00a0risk management plan\u00a0\u00bb<\/p>\n
Les formations initiales ou continues en recherche clinique<\/strong> <\/a>devront s\u2019adapter, afin de permettre aux ARCs d\u2019acqu\u00e9rir ces nouvelles comp\u00e9tences.<\/p>\n
Conclusion\u00a0:
\n<\/strong>Il a \u00e9t\u00e9 d\u00e9montr\u00e9 qu\u2019une fr\u00e9quence \u00e9lev\u00e9e de monitoring sur site ne conduisait pas n\u00e9cessairement \u00e0 une meilleure qualit\u00e9 des donn\u00e9es de l\u2019essai. En apportant plus de clart\u00e9 et d\u2019efficacit\u00e9, le Monitoring bas\u00e9 sur le risque sera la nouvelle norme \u00e0 adopter par tous les ARCs. La nouvelle g\u00e9n\u00e9ration d\u2019ARCs devra donc d\u00e9velopper de nouvelles comp\u00e9tences afin de r\u00e9aliser ce type de monitoring dans les bonnes conditions\u00a0: proactivit\u00e9, comp\u00e9tences en statistiques et analyse, etc.<\/p>\n
L\u2019int\u00e9gration de logiciels de statistiques dans le Monitoring bas\u00e9 sur le risque sera donc indispensable au promoteur pour pr\u00e9venir les risques \u00e9ventuels, et pour l\u2019aider \u00e0 am\u00e9liorer l’efficacit\u00e9 de son processus de monitoring mais aussi la qualit\u00e9 et la fiabilit\u00e9 de ses donn\u00e9es cliniques.<\/p>\n
 <\/p>\n
Sources\u00a0<\/strong>:<\/p>\n
– Journal of clinical research best practices, Vol. 9, N\u00b09, September 2013, \u00ab\u00a0Adaptive monitoring\u00a0: Risk-based monitoring and beyond\u00a0\u00bb by Michael Rosenberg
\n<\/a>– \u00ab\u00a0Competencies for the changing role of the clinical study monitor\u00a0: implementing a risk-based approach to monitoring\u00a0<\/a>\u00bb, April 29, 2014 by Charlene Stubbs et al.
\n– http:\/\/www.cluepoints.com\/solutions\/reduce-regulatory-submission-risk
\n– http:\/\/www.fcrin.org\/<\/a><\/p>\n
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 recherche clinique, technicien de recherche clinique, managers\u00a0et chefs de projet.<\/p>\n
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.<\/p>\n
Retrouve\u00a0\u00ab\u00a0Pharmaspecific\u00a0\u00bb et\u00a0\u00ab\u00a0Vanessa Montanari\u00a0\u00bb \u00a0sur LinkedIn pour avoir de l\u2019actualit\u00e9s pertinentes en recherche clinique en cliquant ici<\/a>\u00a0et\u00a0ici<\/a><\/p>\n
Retrouve nous \u00e9galement sur Viadeo en cliquant ici<\/a>\u00a0et ici<\/a><\/p>\n
Tu peux \u00e9galement t\u2019inscrire \u00e0 la newsletter du blog, nous t\u2019informerons des nouveaux articles d\u00e8s qu\u2019ils seront post\u00e9s.<\/p>\n
\n
Vous avez besoin d\u2019une prestation en recherche clinique? contactez PHARMASPECIFIC en vous rendant sur notre site en cliquant ici : <\/i><\/b>https:\/\/pharmaspecific.com\/devis<\/i><\/b><\/span><\/a><\/span><\/p>\n
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
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>https:\/\/pharmaspecific-training.com\/<\/i><\/span><\/a><\/span><\/p>","protected":false},"excerpt":{"rendered":"
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. Dans cet article, nous te proposons de t\u2019expliquer cette notion qui peut para\u00eetre un peu compliqu\u00e9e de prime abord.<\/p>","protected":false},"author":4,"featured_media":14018,"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":[449],"tags":[16,92,155,103,8,157,158],"class_list":{"0":"post-14016","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-pratiquer-le-metier-dattache-de-recherche-clinique","8":"tag-arc","9":"tag-essai-clinique","10":"tag-etude-clinique","11":"tag-monitoring","12":"tag-recherche-clinique","13":"tag-risk-based-monitoring","14":"tag-statistiques"},"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":"\nLe Risk-based monitoring, une approche qualit\u00e9<\/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\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Le Risk-based monitoring, une nouvelle approche du contr\u00f4le qualit\u00e9 -\" \/>\n<meta property=\"og:url\" content=\"https:\/\/blogdelarechercheclinique.com\/en\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/blogdelarechercheclinique\" \/>\n<meta property=\"article:published_time\" content=\"2015-03-24T21:21:23+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-05-21T09:39:39+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png\" \/>\n\t<meta property=\"og:image:width\" content=\"698\" \/>\n\t<meta property=\"og:image:height\" content=\"696\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Vanessa Montanari\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Vanessa Montanari\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/\"},\"author\":{\"name\":\"Vanessa Montanari\",\"@id\":\"https:\/\/blogdelarechercheclinique.com\/#\/schema\/person\/13ee3f7a1251afe7e98918a482685938\"},\"headline\":\"Le Risk-based monitoring, une nouvelle approche du contr\u00f4le qualit\u00e9\",\"datePublished\":\"2015-03-24T21:21:23+00:00\",\"dateModified\":\"2025-05-21T09:39:39+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/\"},\"wordCount\":1468,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png?fit=698%2C696&ssl=1\",\"keywords\":[\"ARC\",\"essai clinique\",\"Etude clinique\",\"monitoring\",\"recherche clinique\",\"RIsk-based monitoring\",\"Statistiques\"],\"articleSection\":[\"Pratiquer le m\u00e9tier d'Attach\u00e9 de recherche clinique\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/\",\"url\":\"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/\",\"name\":\"Le Risk-based monitoring, une approche qualit\u00e9\",\"isPartOf\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png?fit=698%2C696&ssl=1\",\"datePublished\":\"2015-03-24T21:21:23+00:00\",\"dateModified\":\"2025-05-21T09:39:39+00:00\",\"description\":\"Le risk-based monitoring est une nouvelle approche de contr\u00f4le qualit\u00e9 en recherche clinique. Nous t'expliquons dans l'article.\",\"breadcrumb\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#primaryimage\",\"url\":\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png?fit=698%2C696&ssl=1\",\"contentUrl\":\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png?fit=698%2C696&ssl=1\",\"width\":698,\"height\":696,\"caption\":\"Risk-based monitoring\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\/\/blogdelarechercheclinique.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Le Risk-based monitoring, une nouvelle approche du contr\u00f4le qualit\u00e9\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/blogdelarechercheclinique.com\/#website\",\"url\":\"https:\/\/blogdelarechercheclinique.com\/\",\"name\":\"Blog de la recherche clinique\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/blogdelarechercheclinique.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/blogdelarechercheclinique.com\/#organization\",\"name\":\"Blog de la recherche clinique\",\"url\":\"https:\/\/blogdelarechercheclinique.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/blogdelarechercheclinique.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/04\/cropped-BLOG-logo.png?fit=512%2C512&ssl=1\",\"contentUrl\":\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/04\/cropped-BLOG-logo.png?fit=512%2C512&ssl=1\",\"width\":512,\"height\":512,\"caption\":\"Blog de la recherche clinique\"},\"image\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/blogdelarechercheclinique\"]},{\"@type\":\"Person\",\"@id\":\"https:\/\/blogdelarechercheclinique.com\/#\/schema\/person\/13ee3f7a1251afe7e98918a482685938\",\"name\":\"Vanessa Montanari\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/blogdelarechercheclinique.com\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/ddf428208f542d6c2239ace6606ebe9beb71049642a9c784967f23e4e76e8efc?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/ddf428208f542d6c2239ace6606ebe9beb71049642a9c784967f23e4e76e8efc?s=96&d=mm&r=g\",\"caption\":\"Vanessa Montanari\"},\"url\":\"https:\/\/blogdelarechercheclinique.com\/en\/author\/vanessa\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Le Risk-based monitoring, une approche qualit\u00e9","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/blogdelarechercheclinique.com\/en\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/","og_locale":"en_US","og_type":"article","og_title":"Le Risk-based monitoring, une nouvelle approche du contr\u00f4le qualit\u00e9 -","og_url":"https:\/\/blogdelarechercheclinique.com\/en\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/","article_publisher":"https:\/\/www.facebook.com\/blogdelarechercheclinique","article_published_time":"2015-03-24T21:21:23+00:00","article_modified_time":"2025-05-21T09:39:39+00:00","og_image":[{"width":698,"height":696,"url":"https:\/\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png","type":"image\/png"}],"author":"Vanessa Montanari","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Vanessa Montanari","Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#article","isPartOf":{"@id":"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/"},"author":{"name":"Vanessa Montanari","@id":"https:\/\/blogdelarechercheclinique.com\/#\/schema\/person\/13ee3f7a1251afe7e98918a482685938"},"headline":"Le Risk-based monitoring, une nouvelle approche du contr\u00f4le qualit\u00e9","datePublished":"2015-03-24T21:21:23+00:00","dateModified":"2025-05-21T09:39:39+00:00","mainEntityOfPage":{"@id":"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/"},"wordCount":1468,"commentCount":0,"publisher":{"@id":"https:\/\/blogdelarechercheclinique.com\/#organization"},"image":{"@id":"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#primaryimage"},"thumbnailUrl":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png?fit=698%2C696&ssl=1","keywords":["ARC","essai clinique","Etude clinique","monitoring","recherche clinique","RIsk-based monitoring","Statistiques"],"articleSection":["Pratiquer le m\u00e9tier d'Attach\u00e9 de recherche clinique"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/","url":"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/","name":"Le Risk-based monitoring, une approche qualit\u00e9","isPartOf":{"@id":"https:\/\/blogdelarechercheclinique.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#primaryimage"},"image":{"@id":"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#primaryimage"},"thumbnailUrl":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png?fit=698%2C696&ssl=1","datePublished":"2015-03-24T21:21:23+00:00","dateModified":"2025-05-21T09:39:39+00:00","description":"Le risk-based monitoring est une nouvelle approche de contr\u00f4le qualit\u00e9 en recherche clinique. Nous t'expliquons dans l'article.","breadcrumb":{"@id":"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#primaryimage","url":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png?fit=698%2C696&ssl=1","contentUrl":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png?fit=698%2C696&ssl=1","width":698,"height":696,"caption":"Risk-based monitoring"},{"@type":"BreadcrumbList","@id":"https:\/\/blogdelarechercheclinique.com\/le-risk-based-monitoring-une-nouvelle-approche-du-controle-qualite-2\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/blogdelarechercheclinique.com\/"},{"@type":"ListItem","position":2,"name":"Le Risk-based monitoring, une nouvelle approche du contr\u00f4le qualit\u00e9"}]},{"@type":"WebSite","@id":"https:\/\/blogdelarechercheclinique.com\/#website","url":"https:\/\/blogdelarechercheclinique.com\/","name":"Blog de la recherche clinique","description":"","publisher":{"@id":"https:\/\/blogdelarechercheclinique.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/blogdelarechercheclinique.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/blogdelarechercheclinique.com\/#organization","name":"Blog de la recherche clinique","url":"https:\/\/blogdelarechercheclinique.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/blogdelarechercheclinique.com\/#\/schema\/logo\/image\/","url":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/04\/cropped-BLOG-logo.png?fit=512%2C512&ssl=1","contentUrl":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/04\/cropped-BLOG-logo.png?fit=512%2C512&ssl=1","width":512,"height":512,"caption":"Blog de la recherche clinique"},"image":{"@id":"https:\/\/blogdelarechercheclinique.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/blogdelarechercheclinique"]},{"@type":"Person","@id":"https:\/\/blogdelarechercheclinique.com\/#\/schema\/person\/13ee3f7a1251afe7e98918a482685938","name":"Vanessa Montanari","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/blogdelarechercheclinique.com\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/ddf428208f542d6c2239ace6606ebe9beb71049642a9c784967f23e4e76e8efc?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/ddf428208f542d6c2239ace6606ebe9beb71049642a9c784967f23e4e76e8efc?s=96&d=mm&r=g","caption":"Vanessa Montanari"},"url":"https:\/\/blogdelarechercheclinique.com\/en\/author\/vanessa\/"}]}},"jetpack_featured_media_url":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png?fit=698%2C696&ssl=1","jetpack-related-posts":[{"id":16298,"url":"https:\/\/blogdelarechercheclinique.com\/en\/lich-e6-r3-comment-le-comprendre-avec-transcelerate\/","url_meta":{"origin":14016,"position":0},"title":"Navigating the ICH E6(R3) Transition: Expert Insights & Tools","author":"Virginie Smartelia","date":"2 March 2026","format":false,"excerpt":"{:fr} La version finale de l\u2019ICH E6(R3) change les r\u00e8gles du jeu dans la recherche clinique.Plus flexible, plus logique et mieux adapt\u00e9e \u00e0 l\u2019utilisation de l\u2019outil num\u00e9rique, elle pousse chacun \u00e0 revoir ses habitudes. Mais soyons honn\u00eates, entre les annexes, les nouveaux concepts et les obligations de conformit\u00e9, ce n\u2019est\u2026","rel":"","context":"In "Non class\u00e9"","block_context":{"text":"Non class\u00e9","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/non-classe\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2026\/03\/Image.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2026\/03\/Image.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2026\/03\/Image.png?resize=525%2C300&ssl=1 1.5x"},"classes":[]},{"id":15932,"url":"https:\/\/blogdelarechercheclinique.com\/en\/attache-de-recherche-clinique-bienvenue-en-2025\/","url_meta":{"origin":14016,"position":1},"title":"Clinical Research Associate on 2025","author":"Virginie Smartelia","date":"27 October 2025","format":false,"excerpt":"{:fr} Et si l'ARC de 2025 n'avait plus grand-chose \u00e0 voir avec celui d'il y a cinq ans ? Digitalisation des essais, outils d'IA, r\u00e9glementations renforc\u00e9es\u2026 Le m\u00e9tier se red\u00e9finit et s'adapter devient un imp\u00e9ratif. L'IA au c\u0153ur des essais cliniques : un nouveau r\u00f4le pour l'ARC L'intelligence artificielle est\u2026","rel":"","context":"In "Actualit\u00e9s de la recherche clinique"","block_context":{"text":"Actualit\u00e9s de la recherche clinique","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/actualites-de-la-recherche-clinique\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":697,"url":"https:\/\/blogdelarechercheclinique.com\/en\/risk-based-monitoring\/","url_meta":{"origin":14016,"position":2},"title":"The risk-based monitoring: a new method for quality control?","author":"Vanessa Montanari","date":"24 March 2015","format":false,"excerpt":"In a few years, we are seeing a real change in how to make a clinical trial monitoring at the international level. In this article we will explain you this concept that may seem a bit complicated at first.","rel":"","context":"In "Pratiquer le m\u00e9tier d'Attach\u00e9 de recherche clinique"","block_context":{"text":"Pratiquer le m\u00e9tier d'Attach\u00e9 de recherche clinique","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/pratiquer-le-metier-dattache-de-recherche-clinique\/"},"img":{"alt_text":"Risk-based monitoring","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png?fit=698%2C696&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png?fit=698%2C696&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/risk-based.png?fit=698%2C696&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":13938,"url":"https:\/\/blogdelarechercheclinique.com\/en\/mise-a-jour-et-consultation-publique-de-lich-e6\/","url_meta":{"origin":14016,"position":3},"title":"Mise \u00e0 jour et consultation publique de l’ICH E6","author":"Vanessa Montanari","date":"21 October 2015","format":false,"excerpt":"En tant que TEC, ARC ou Chef de projet, tu dois connaitre sur le bout des doigts les ICH (International Conference on Harmonisation). Mais sais-tu qu\u2019en Juin dernier ce document a \u00e9t\u00e9 mis \u00e0 jour ? Si oui, c\u2019est parfait\u00a0! Si non, il est encore temps de te rattraper.","rel":"","context":"In "Les r\u00e8glementaires"","block_context":{"text":"Les r\u00e8glementaires","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/reglementaires\/"},"img":{"alt_text":"Mise \u00e0 jour ICH E6","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/ICH.png?fit=1035%2C687&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/ICH.png?fit=1035%2C687&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/ICH.png?fit=1035%2C687&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/ICH.png?fit=1035%2C687&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":15858,"url":"https:\/\/blogdelarechercheclinique.com\/en\/lia-en-recherche-clinique-le-guide-simple-pour-les-petites-structures\/","url_meta":{"origin":14016,"position":4},"title":"AI in Clinical Research: The Simple Guide for Small Organizations.","author":"Virginie Smartelia","date":"7 October 2025","format":false,"excerpt":"{:fr} Solutions IA pour petites CRO et structures cliniques L'Intelligence Artificielle (IA) est l\u00e0, et elle bouscule tout, m\u00eame dans notre monde ultra-r\u00e9glement\u00e9. Que vous soyez dans une petite CRO, une PME Biotech, ou une \u00e9quipe op\u00e9rationnelle (ARC, TEC, Contract Specialist), l'IA est une chance folle de gagner du temps\u2026","rel":"","context":"In "Actualit\u00e9s de la recherche clinique"","block_context":{"text":"Actualit\u00e9s de la recherche clinique","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/actualites-de-la-recherche-clinique\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2025\/10\/lIA-dans-la-medecine-1.png?fit=1200%2C972&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2025\/10\/lIA-dans-la-medecine-1.png?fit=1200%2C972&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2025\/10\/lIA-dans-la-medecine-1.png?fit=1200%2C972&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2025\/10\/lIA-dans-la-medecine-1.png?fit=1200%2C972&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2025\/10\/lIA-dans-la-medecine-1.png?fit=1200%2C972&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":843,"url":"https:\/\/blogdelarechercheclinique.com\/en\/study-bmr-routine-care\/","url_meta":{"origin":14016,"position":5},"title":"Your study : BMR or routine care?","author":"Vanessa Montanari","date":"17 June 2015","format":"image","excerpt":"Today, the typology of clinical research studies is based on the Code of Public Health. Despite its publication in the Official newspaper\u00a0in March 2012, the Jard\u00e9 law that planned, among other things, a new typology of research based on risk, is still not implemented and is suspended to the publication\u2026","rel":"","context":"In "Devenir Attach\u00e9 de recherche clinique: formation, financement"","block_context":{"text":"Devenir Attach\u00e9 de recherche clinique: formation, financement","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/devenir-attache-de-recherche-clinique\/"},"img":{"alt_text":"URC CIC","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2015\/06\/URC-CIC-Necker-Cochin.png?fit=794%2C502&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2015\/06\/URC-CIC-Necker-Cochin.png?fit=794%2C502&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2015\/06\/URC-CIC-Necker-Cochin.png?fit=794%2C502&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2015\/06\/URC-CIC-Necker-Cochin.png?fit=794%2C502&ssl=1&resize=700%2C400 2x"},"classes":[]}],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts\/14016","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/comments?post=14016"}],"version-history":[{"count":3,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts\/14016\/revisions"}],"predecessor-version":[{"id":14020,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts\/14016\/revisions\/14020"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/media\/14018"}],"wp:attachment":[{"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/media?parent=14016"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/categories?post=14016"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/tags?post=14016"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}