{"id":14302,"date":"2024-06-07T11:21:48","date_gmt":"2024-06-07T09:21:48","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=14302"},"modified":"2025-05-21T11:14:44","modified_gmt":"2025-05-21T09:14:44","slug":"grade-evenments-indesirables","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/grade-evenments-indesirables\/","title":{"rendered":"Challenge #7 Pas de grade des \u00e9v\u00e8nements ind\u00e9sirables et de lien au produit \u00e0 l&rsquo;\u00e9tude dans le dossier m\u00e9dical. Que faire?"},"content":{"rendered":"<p>Challenge #7 Pas de grade des AE et de lien au produit \u00e0 l&rsquo;\u00e9tude dans le dossier m\u00e9dical. Que faire?<\/p>\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 data-src=\"https:\/\/www.youtube.com\/embed\/xi30lF-FSRY\" 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>Bonjour \u00e0 tous ! C&rsquo;est Vanessa Montanari et du blog la recherche clinique pour Pharmaspecific. Aujourd&rsquo;hui, on va parler d&rsquo;un nouveau sujet. Vous vous rendez compte que les \u00e9v\u00e9nements ind\u00e9sirables ne sont pas grad\u00e9s dans le dossier source, que faire ?<\/p>\n<p>Alors, c&rsquo;est quelque chose qui peut arriver. L&rsquo;investigateur\u00a0n&rsquo;a pas grad\u00e9 les \u00e9v\u00e9nements ind\u00e9sirables. Donc, si \u00e7a arrive pour un petit nombre d&rsquo;\u00e9v\u00e9nements ind\u00e9sirables, c&rsquo;est assez simple, vous <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/investigateurae\/\">demandez \u00e0 l&rsquo;investigateur\u00a0de grader les \u00e9v\u00e9nements ind\u00e9sirables<\/a> et de pr\u00e9ciser \u00e9galement si c&rsquo;est li\u00e9 ou non au produit \u00e0 l&rsquo;\u00e9tude.<\/p>\n<p>Dans le cas o\u00f9 vous\u00a0avez\u00a0un grand nombre d&rsquo;<a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>\u00e9v\u00e9nements ind\u00e9sirables non grad\u00e9s<\/strong><\/a>, \u00e0\u00a0ce moment-l\u00e0, il va falloir trouver une autre mani\u00e8re de fonctionner. Tout d&rsquo;abord, vous allez demander au technicien d&rsquo;\u00e9tude\u00a0clinique comment il s&rsquo;organise pour r\u00e9cup\u00e9rer ces informations-l\u00e0. Les grades et la liaison, est-ce que l&rsquo;\u00e9v\u00e9nement ind\u00e9sirable est li\u00e9 au produit ou pas. Comment il s&rsquo;organise\u00a0pour pouvoir r\u00e9cup\u00e9rer sa formation. Est-ce qu&rsquo;il a un document pour r\u00e9cup\u00e9rer ces informations-l\u00e0 ? Comment il proc\u00e8de ? S&rsquo;il y a une organisation qui est mise en place donc, il y a\u00a0probablement\u00a0une fiche sur laquelle il note l&rsquo;information, il demande l&rsquo;information \u00e0 l&rsquo;investigateur.\u00a0\u00c0 ce moment-l\u00e0, ces fiches vont\u00a0servir de documents sources et vont \u00eatre\u00a0utilis\u00e9s.\u00a0Si par contre, il n&rsquo;y a pas d&rsquo;autres documents sources pour pouvoir documenter ces informations-l\u00e0, moi, ce que je pr\u00e9conise c&rsquo;est de proposer un tableau pr\u00e9 construit \u00e0 l&rsquo;investigateur\u00a0et au technicien d&rsquo;\u00e9tudes cliniques dans lequel ils vont pouvoir reporter tous <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>les \u00e9v\u00e9nements ind\u00e9sirables de l&rsquo;\u00e9tude<\/strong><\/a> avec le grade et la liaison au produit. De cette mani\u00e8re-l\u00e0, le technicien d&rsquo;\u00e9tudes cliniques va remplir tous les \u00e9v\u00e9nements ind\u00e9sirables du patient et va demander \u00e0 l&rsquo;investigateur\u00a0de grader et de mettre s&rsquo;il est li\u00e9 ou non au produit. L&rsquo;investigateur\u00a0signera et datera ce document et ce dernier servira de document source pour le monitoring. Il faut absolument que vous reformiez le technicien d&rsquo;\u00e9tudes cliniques et l&rsquo;investigateur\u00a0au fait qu&rsquo;il faut graver et donner la liaison ou pas au produit \u00e0 l&rsquo;\u00e9tude de ces diff\u00e9rents \u00e9v\u00e9nements ind\u00e9sirables graves.\u00a0A\u00a0partir du moment o\u00f9 vous former l&rsquo;investigateur\u00a0et le\u00a0technicien\u00a0d&rsquo;\u00e9tudes cliniques, il faut absolument que vous pr\u00e9pariez un formulaire de formation. Il va falloir \u00e9galement reporter les faits dans votre lettre de suivi que vous avez\u00a0adress\u00e9e\u00a0\u00e0 l&rsquo;investigateur\u00a0et puis \u00e9galement dans le rapport de monitoring.<\/p>\n<p>J&rsquo;esp\u00e8re que cette vid\u00e9o vous aura aid\u00e9. Si vous avez aim\u00e9 ce programme,\u00a0mettez j&rsquo;aime en bas de la vid\u00e9o.<\/p>\n<p>Je voudrais \u00e9galement vous dire que Pharmaspecific a cr\u00e9\u00e9 un livre blanc pour vous expliquer \u00ab\u00a0comment mener vos \u00e9tudes cliniques au succ\u00e8s\u00a0\u00bb. Ce guide est un guide d&rsquo;une centaine de pages. Il s&rsquo;agit de retour d&rsquo;exp\u00e9rience de notre \u00e9quipe pour vous aider \u00e0 mieux appr\u00e9hender les essais cliniques. Vous pouvez t\u00e9l\u00e9charger ce guide en bas de la vid\u00e9o. Vous pouvez aller visiter le blog la recherche clinique pour avoir plus de conseils en recherche clinique, l&rsquo;adresse est ici. Vous pouvez \u00e9galement visiter le site de Pharmaspecific, l&rsquo;adresse est ici.\u00a0Pharmaspecific\u00a0est une <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>CRO sp\u00e9cialis\u00e9e en recherche clinique<\/strong><\/a>. Donc, je vous laisse aller voir nos activit\u00e9s et ce que nous proposons comme prestations. Merci de nous suivre.<\/p>\n<p>\u00c0 bient\u00f4t ! Au revoir.<\/p>","protected":false},"excerpt":{"rendered":"<p>Aujourd&rsquo;hui, on va parler d&rsquo;un nouveau sujet. Vous vous rendez compte que les \u00e9v\u00e9nements ind\u00e9sirables ne sont pas grad\u00e9s dans le dossier source, que faire ?<\/p>","protected":false},"author":4,"featured_media":14306,"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-14302","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>Pas de grade des \u00e9v\u00e8nements ind\u00e9sirables<\/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\/grade-evenments-indesirables\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Challenge #7 Pas de grade des \u00e9v\u00e8nements ind\u00e9sirables et de lien au produit \u00e0 l&#039;\u00e9tude dans le dossier m\u00e9dical. 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