{"id":6036,"date":"2019-03-13T13:30:06","date_gmt":"2019-03-13T12:30:06","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=6036"},"modified":"2025-05-21T11:30:24","modified_gmt":"2025-05-21T09:30:24","slug":"perte-consentement-eclaire","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/perte-consentement-eclaire\/","title":{"rendered":"Cas d&rsquo;\u00e9tude: La perte d&rsquo;un consentement \u00e9clair\u00e9! Catastrophe"},"content":{"rendered":"<p><em>Clique sur la vid\u00e9o pour \u00e9couter ce cas d&rsquo;\u00e9tude et inscris toi \u00e0 notre chaine YouTube, pour \u00eatre inform\u00e9 imm\u00e9diatement (on en a plusieurs en stock)\u00a0 \ud83d\ude42 N&rsquo;oublies pas de liker, si tu as aim\u00e9 la vid\u00e9o !!!<\/em><\/p>\n<p><iframe data-src=\"https:\/\/www.youtube.com\/embed\/su58ebj3NMQ\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" class=\"lazyload\" data-load-mode=\"1\"><\/iframe><\/p>\n<p>Tu vas sur le site et il n&rsquo;y a plus de consentement. Tu y \u00e9tais aller la derni\u00e8re fois mais ils \u00e9taient l\u00e0. Et l\u00e0, il n&rsquo;y a plus de consentement. Que faire ? <!--more--> Bonjour \u00e0 tous, c&rsquo;est Vanessa Montanari du blog de la recherche clinique. Je vais vous parler d&rsquo;un petit cas concret en recherche clinique. Donc, la question est que faire en cas de <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>perte d&rsquo;un consentement \u00e9clair\u00e9.<\/strong><\/a> Tu es all\u00e9 sur site, les consentements \u00e9taient cens\u00e9s \u00eatre sur site et ils n&rsquo;y sont plus. Qu&rsquo;est-ce tu dois faire ? Dans un premier temps, il faut que tu en parles directement \u00e0 ton investigateur pour voir o\u00f9 est-ce que ces consentements ont \u00e9t\u00e9 mis et s&rsquo;il sait o\u00f9 est-ce qu&rsquo;ils se trouvent. Ensuite, deuxi\u00e8me chose, tu contactes ton chef de projet pour m&rsquo;informer de ce probl\u00e8me et surtout, tu n&rsquo;ouvres pas les dossiers m\u00e9dicaux. Pas de consentements, pas de dossiers m\u00e9dicaux. M\u00eame si, le consentement \u00e9tait l\u00e0 avant, tu ne dois pas y toucher. Il faut \u00e9galement documenter tout \u00e7a dans le rapport de monitoring et demander \u00e0 ce que l&rsquo;investigateur documente l&rsquo;information dans le dossier m\u00e9dical. Il faudra <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/la-recherche-clinique-sur-les-dispositifs-medicaux-comment-sy-prendre\/\"><strong>refaire signer tous les consentements aux patients<\/strong><\/a> \u00e0 la date du jour o\u00f9 le consentement est sign\u00e9. C&rsquo;est-\u00e0-dire, on n&rsquo;antidate pas les consentements.<\/p>\n<p>Par contre, une petite note peut \u00eatre mise sur le consentement m\u00eame ou le patient va \u00e9crire sur ce consentement qu&rsquo;il avait sign\u00e9 le consentement \u00ab\u00a0le temps\u00a0\u00bb, et l&rsquo;investigateur aussi peut mettre une petite note comme quoi le consentement avait \u00e9t\u00e9 sign\u00e9 et qu&rsquo;il est perdu. Voil\u00e0, \u00e7a peut permettre aussi de montrer que les choses avaient \u00e9t\u00e9 faites de demander au patient de noter cette information sur le consentement. Voil\u00e0. Donc, j&rsquo;esp\u00e8re que ce petit cas concret t&rsquo;aura aid\u00e9 et que tu n&rsquo;es pas dans cette situation. Bon courage ! <em>Vous avez besoin d&rsquo;<\/em><strong>une prestation en recherche clinique ?<\/strong> <em>contactez<\/em> <strong>PHARMASPECIFIC <\/strong><em>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> <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> <em>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\u00a0<a href=\"https:\/\/pharmaspecific-training.com\/\">https:\/\/pharmaspecific-training.com\/ <\/a><\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>Tu vas sur le site et il n&rsquo;y a plus de consentement. Tu y \u00e9tais aller la derni\u00e8re fois mais ils \u00e9taient l\u00e0. Et l\u00e0, il n&rsquo;y a plus de consentement. Que faire ?<\/p>","protected":false},"author":4,"featured_media":14579,"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":[],"class_list":{"0":"post-6036","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-pratiquer-le-metier-dattache-de-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>Cas d&#039;\u00e9tude: La perte d&#039;un consentement \u00e9clair\u00e9! Catastrophe<\/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\/perte-consentement-eclaire\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cas d&#039;\u00e9tude: La perte d&#039;un consentement \u00e9clair\u00e9! 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Voici un petit guide pour t\u2019aider \u00e0 revoir les formulaires de consentement \u00e9clair\u00e9 et les notes d\u2019information au patient.","rel":"","context":"In &quot;Pratiquer le m\u00e9tier d'Attach\u00e9 de recherche clinique&quot;","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":"Appel au secours","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/appel-secours.png?fit=737%2C490&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/appel-secours.png?fit=737%2C490&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/appel-secours.png?fit=737%2C490&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/appel-secours.png?fit=737%2C490&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":13611,"url":"https:\/\/blogdelarechercheclinique.com\/en\/liste-preselection-initiales-patient\/","url_meta":{"origin":6036,"position":5},"title":"Est-il possible de remplir la liste de pr\u00e9s\u00e9lection par les initiales du patient?","author":"Vanessa Montanari","date":"21 April 2021","format":false,"excerpt":"La question du jour est celle de savoir si lorsque l\u2019on a une liste de pr\u00e9s\u00e9lection, il est possible d\u2019y entrer les initiales du patient avant m\u00eame que celui-ci ait sign\u00e9 son consentement \u00e9clair\u00e9.","rel":"","context":"In &quot;Les r\u00e8glementaires&quot;","block_context":{"text":"Les r\u00e8glementaires","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/reglementaires\/"},"img":{"alt_text":"remplir la liste de pr\u00e9s\u00e9lection par les initiales du patient","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/Liste-preselection.png?fit=1165%2C662&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/Liste-preselection.png?fit=1165%2C662&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/Liste-preselection.png?fit=1165%2C662&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/Liste-preselection.png?fit=1165%2C662&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/Liste-preselection.png?fit=1165%2C662&ssl=1&resize=1050%2C600 3x"},"classes":[]}],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts\/6036","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=6036"}],"version-history":[{"count":1,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts\/6036\/revisions"}],"predecessor-version":[{"id":14580,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts\/6036\/revisions\/14580"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/media\/14579"}],"wp:attachment":[{"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/media?parent=6036"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/categories?post=6036"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/tags?post=6036"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}