{"id":14215,"date":"2020-01-21T18:00:01","date_gmt":"2020-01-21T17:00:01","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=14215"},"modified":"2025-09-01T18:24:27","modified_gmt":"2025-09-01T16:24:27","slug":"signature-consentement-eclaire","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/signature-consentement-eclaire\/","title":{"rendered":"Challenge #20 : Que v\u00e9rifier lors de la signature d&rsquo;un consentement \u00e9clair\u00e9?"},"content":{"rendered":"<h2>Challenge #20 : Que v\u00e9rifier lors de la signature d&rsquo;un consentement \u00e9clair\u00e9?<\/h2>\n<p>Cette ann\u00e9e sera celle de la rencontre, du partage, de la connaissance et du d\u00e9veloppement. Es tu pr\u00eat avec nous? Cela commencera par notre challenge 2020, une vid\u00e9o par jour pendant 30 jours sur le monitoring.<\/p>\n<p>Pendant 30 jours, nous allons te donner du contenu \u00e0 forte valeur ajout\u00e9 pour du monitoring de qualit\u00e9!<\/p>\n<p><!--more--><em>Rejoins nous sur Instagram en cliquant ici<\/em> <strong>:<\/strong>\u00a0<a href=\"https:\/\/www.instagram.com\/blogrechercheclinique\/\">https:\/\/www.instagram.com\/blogrechercheclinique\/<\/a><\/p>\n<p><em>Vous avez besoin d&rsquo;une prestation en recherche clinique ? contactez PHARMASPECIFIC en vous rendant sur notre site en cliquant ici :<\/em><strong><a href=\"https:\/\/pharmaspecific.com\/devis\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/pharmaspecific.com\/devis\/<\/a><\/strong><\/p>\n<p><em>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.\u00a0<\/em><\/p>\n<p><iframe title=\"Challenge #20 : Que v\u00e9rifier lors de la signature d&#039;un consentement \u00e9clair\u00e9?\" width=\"1080\" height=\"608\" data-src=\"https:\/\/www.youtube.com\/embed\/EXlnfs_HeH8?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" class=\"lazyload\" data-load-mode=\"1\"><\/iframe><\/p>\n<p>Bonjour \u00e0 tous. C&rsquo;est Vanessa Montanari du blog de la recherche clinique pour Pharmaspecific. Aujourd&rsquo;hui, on va voir un nouveau sujet. Qu&rsquo;est-ce que vous devez v\u00e9rifier lorsque vous v\u00e9rifiez un <strong>consentement \u00e9clair\u00e9<\/strong> pour un premier patient ?<\/p>\n<p><!--more--><\/p>\n<p>Donc, tout d&rsquo;abord, vous devez vous assurer que l&rsquo;investisseur qui a sign\u00e9 le <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>consentement \u00e9clair\u00e9<\/strong><\/a> est un investigateur autoris\u00e9 \u00e0 exercer la m\u00e9decine. Vous pouvez le voir sur le site du CNOM. Ce m\u00e9decin, il doit \u00e9galement \u00eatre sur la d\u00e9l\u00e9gation log, le formulaire de d\u00e9l\u00e9gation des t\u00e2ches. Deuxi\u00e8me chose, vous devez vous assurer qu&rsquo;ils ont sign\u00e9 soit \u00e0 la m\u00eame date soit que l&rsquo;investigateur a \u00e9ventuellement sign\u00e9 apr\u00e8s le patient mais l&rsquo;inverse n&rsquo;est pas possible. Je vous rapporte \u00e0 ma vid\u00e9o du challenge num\u00e9ro 1 pour pouvoir voir pourquoi, en d\u00e9tail, c&rsquo;est important. Troisi\u00e8mement, vous devez vous assurer que tous les champs ont \u00e9t\u00e9 compl\u00e9t\u00e9s, que les croix ont \u00e9t\u00e9 mises l\u00e0 o\u00f9 elles devaient \u00eatre dans ce consentement. Quatri\u00e8mement, vous devez vous assurer qu&rsquo;une copie a \u00e9t\u00e9 remise au patient. Cette information doit se retrouver dans le dossier m\u00e9dical. Alors, vous devez vous assurer qu&rsquo;un exemplaire a \u00e9t\u00e9 donn\u00e9 aux patients. Cette information doit se trouver dans le dossier m\u00e9dical. Vous devez \u00e9galement vous assurer de la v\u00e9racit\u00e9 des informations et des donn\u00e9es personnelles : le nom, le pr\u00e9nom, l&rsquo;adresse du patient ainsi que la date de naissance. Vous devez vous assurer que le patient a sign\u00e9 son consentement avant toute proc\u00e9dure de l&rsquo;\u00e9tude. Par exemple, il peut arriver que certains investigateurs sachent que le patient doit faire un test de l&rsquo;h\u00e9patite B dans le cadre de l&rsquo;\u00e9tude. Alors, avant m\u00eame que <strong><a href=\"https:\/\/blogdelarechercheclinique.com\/en\/b-a-ba-consentement-mineurs-recherche-clinique\/\">le patient signe le consentement<\/a><\/strong>, l&rsquo;investigateur lui fait faire ce test sans raison sauf la raison de l&rsquo;\u00e9tude. Vous devez bien faire comprendre \u00e0 l&rsquo;investigateur qu&rsquo;il faut \u00e9viter de faire ce genre de choses et que le patient ne peut d\u00e9buter les examens qu&rsquo;\u00e0 partir du moment o\u00f9 il a<a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong> sign\u00e9 le consentement \u00e9clair\u00e9<\/strong><\/a>. Vous devez \u00e9galement vous assurer que l&rsquo;investigateur de l&rsquo;\u00e9tude ait bien report\u00e9 sur\u00a0 la FDA 1572, s&rsquo;il s&rsquo;agit d&rsquo;une \u00e9tude IND. Les \u00e9tudes IND sont des \u00e9tudes dont l&rsquo;objectif est d&rsquo;\u00eatre mis sur le march\u00e9 aux \u00e9tats unis et ce formulaire est n\u00e9cessaire dans le cadre de ce type d&rsquo;\u00e9tude. Donc, vous devez vous assurer que l&rsquo;investigateur ait bien report\u00e9 sur ce formulaire. Vous devez \u00e9galement vous assurer que le process de recueil du consentement a \u00e9t\u00e9 fait correctement. En principe, l&rsquo;investigateur doit indiquer le process de recueil du consentement au niveau du dossier m\u00e9dical. Par exemple, le consentement a \u00e9t\u00e9 revu avec le patient, le consentement a \u00e9t\u00e9 sign\u00e9 telle date, le patient a eu le temps de poser toutes les questions n\u00e9cessaires dans le cadre de l&rsquo;\u00e9tude. Voil\u00e0 ce que je voulais vous dire sur les consentements \u00e9clair\u00e9s.<\/p>\n<p>J&rsquo;esp\u00e8re que \u00e7a vous a aid\u00e9. Si vous voulez en savoir plus sur la recherche clinique, il faut aller sur le bloc de la recherche clinique, le lien c&rsquo;est ici. Si vous voulez en savoir plus sur Pharmaspecific, notre CRO sp\u00e9cialis\u00e9 en recherche clinique, le lien est ici. Sachez que Pharmaspecific a cr\u00e9\u00e9 un livre blanc pour vous aider \u00e0 mieux appr\u00e9hender les <strong>\u00e9tudes cliniques<\/strong>. Vous pouvez le t\u00e9l\u00e9charger en dessous. Il s&rsquo;agit d&rsquo;un guide d&rsquo;une centaine de pages qui sont des retours d&rsquo;exp\u00e9rience de nos \u00e9quipes. Si vous avez aim\u00e9 cette vid\u00e9o, mettez j&rsquo;aime en bas de la vid\u00e9o. Vous pouvez me mettre des commentaires, je vous r\u00e9pondrais. Je serai contente d&rsquo;avoir vos avis. Merci de nous suivre.<\/p>\n<p>A bient\u00f4t. Au revoir !<\/p>","protected":false},"excerpt":{"rendered":"<p>Aujourd&rsquo;hui, on va voir un nouveau sujet. Qu&rsquo;est-ce que vous devez v\u00e9rifier lorsque vous v\u00e9rifiez un consentement \u00e9clair\u00e9 pour un premier patient ?<\/p>","protected":false},"author":4,"featured_media":14216,"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":[66,41,155,8],"class_list":{"0":"post-14215","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-attache-de-recherche-clinique","9":"tag-cro","10":"tag-etude-clinique","11":"tag-recherche-clinique"},"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>Que v\u00e9rifier lors de la signature d&#039;un consentement \u00e9clair\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\/signature-consentement-eclaire\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Challenge #20 : Que v\u00e9rifier lors de la signature d&#039;un consentement \u00e9clair\u00e9? 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