La pharmacovigilance consiste \u00e0 observer les risques li\u00e9s aux m\u00e9dicaments, c’est-\u00e0-dire \u00e0 toute manifestation nocive survenant chez une personne qui se pr\u00eate \u00e0 une recherche biom\u00e9dicale, que cette manifestation soit li\u00e9e ou non \u00e0 la recherche ou au m\u00e9dicament exp\u00e9rimental sur lequel porte cette recherche. Elle sert principalement de support pour la Haute Autorit\u00e9 de Sant\u00e9 – HAS \u2013 mais \u00e9galement pour le minist\u00e8re de la Sant\u00e9 et l\u2019Agence Nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 – ANSM. Ainsi, les \u00e9v\u00e9nements ind\u00e9sirables<\/b> \u2013 EI – survenant durant l’\u00e9tude sont \u00e0 d\u00e9clarer dans le formulaire \u00e9lectronique – e-CRF :<\/p>\n
\u2013 pour les patients ayant ou ayant eu une h\u00e9patite B<\/strong> et pour les patients ayant ou ayant eu une h\u00e9patite C hors p\u00e9riode de traitement<\/strong>, uniquement les EIs s\u00e9v\u00e8res c\u2019est-\u00e0-dire de grades 3 et 4 (selon les grades ANRS),<\/p>\n
\u2013 pour les patients ayant une h\u00e9patite C durant la p\u00e9riode de traitement<\/strong>, les EIs de tout grade durant toute la dur\u00e9e du traitement.<\/p>\n
Les \u00e9v\u00e9nements ind\u00e9sirables graves<\/strong> – EIG \u2013 est un \u00e9v\u00e8nement:<\/p>\n
– dont l’\u00e9volution est fatale,<\/p>\n
– ou qui est met en danger la vie de la personne qui se pr\u00eate \u00e0 la recherche,<\/p>\n
– ou qui entra\u00eene une incapacit\u00e9 ou un handicap important ou durable,<\/p>\n
– ou qui provoque une hospitalisation ou une prolongation d’hospitalisation<\/p>\n
– ou qui a pour cons\u00e9quence une anomalie ou une malformation cong\u00e9nitale<\/p>\n
– ou tout autre \u00e9v\u00e9nement ne r\u00e9pondant pas aux qualifications \u00e9num\u00e9r\u00e9es ci-dessus, mais pouvant \u00eatre consid\u00e9r\u00e9 comme \u00ab potentiellement grave \u00bb notamment certaines anomalies biologiques<\/p>\n
– ou \u00e9v\u00e9nement m\u00e9dicalement pertinent selon le jugement de l\u2019investigateur<\/p>\n
– ou encore un \u00e9v\u00e9nement n\u00e9cessitant une intervention m\u00e9dicale pour pr\u00e9venir l\u2019\u00e9volution vers un des \u00e9tats pr\u00e9cit\u00e9s.<\/p>\n
Tous les EIGs sont suivis jusqu’\u00e0 leur r\u00e9solution ou leur stabilisation le cas \u00e9ch\u00e9ant. Ces d\u00e9clarations se font en temps r\u00e9el, sans attendre la visite de suivie pr\u00e9vue au protocole. Les grossesses doivent \u00eatre d\u00e9clar\u00e9es dans les 24 heures au Centre de M\u00e9thodologie et de Gestion – CMG et sont suivies \u00e0 l’accouchement via un formulaire de d\u00e9claration compl\u00e9mentaire de grossesse \u00e0 compl\u00e9ter. Processus de d\u00e9claration en cas d’EIG :<\/b>
La pharmacovigilance consiste \u00e0 observer les risques li\u00e9s aux m\u00e9dicaments, c’est-\u00e0-dire \u00e0 toute manifestation nocive survenant chez une personne qui se pr\u00eate \u00e0 une recherche biom\u00e9dicale, que cette manifestation soit li\u00e9e ou non \u00e0 la recherche ou au m\u00e9dicament exp\u00e9rimental sur lequel porte cette recherche.Elle sert principalement de support pour la Haute Autorit\u00e9 de Sant\u00e9 […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":165,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"jetpack_post_was_ever_published":false,"footnotes":""},"class_list":["post-1060","page","type-page","status-publish","hentry"],"yoast_head":"\n
Pharmacovigilance - ANRS CO22 HEPATHER<\/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:\/\/triton.iplesp.upmc.fr\/hepather_ANRS\/la-cohorte\/description-de-la-cohorte\/pharmacovigilance\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmacovigilance - ANRS CO22 HEPATHER\" \/>\n<meta property=\"og:description\" content=\"La pharmacovigilance consiste \u00e0 observer les risques li\u00e9s aux m\u00e9dicaments, c’est-\u00e0-dire \u00e0 toute manifestation nocive survenant chez une personne qui se pr\u00eate \u00e0 une recherche biom\u00e9dicale, que cette manifestation soit li\u00e9e ou non \u00e0 la recherche ou au m\u00e9dicament exp\u00e9rimental sur lequel porte cette recherche.Elle sert principalement de support pour la Haute Autorit\u00e9 de Sant\u00e9 […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/triton.iplesp.upmc.fr\/hepather_ANRS\/la-cohorte\/description-de-la-cohorte\/pharmacovigilance\/\" \/>\n<meta property=\"og:site_name\" content=\"ANRS CO22 HEPATHER\" \/>\n<meta property=\"article:modified_time\" content=\"2022-03-30T12:59:05+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/triton.iplesp.upmc.fr\/hepather_ANRS\/wp-content\/uploads\/2022\/03\/pharmacovigilance.png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/triton.iplesp.upmc.fr\/hepather_ANRS\/la-cohorte\/description-de-la-cohorte\/pharmacovigilance\/\",\"url\":\"https:\/\/triton.iplesp.upmc.fr\/hepather_ANRS\/la-cohorte\/description-de-la-cohorte\/pharmacovigilance\/\",\"name\":\"Pharmacovigilance - 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Minist\u00e8re de la\u2026","rel":"","context":"Article similaire","block_context":{"text":"Article similaire","link":""},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":1475,"url":"https:\/\/triton.iplesp.upmc.fr\/hepather_ANRS\/la-cohorte\/description-de-la-cohorte\/recueil-de-donnees\/","url_meta":{"origin":1060,"position":1},"title":"Recueil de donn\u00e9es","author":"admin_ft","date":"30 octobre 2018","format":false,"excerpt":"Le recueil de donn\u00e9es se fait lors des consultations cliniques des patients. Le protocole pr\u00e9voit une visite d\u2019inclusion et une visite annuelle pendant 7 \u00e0 8 ans. Toutes les donn\u00e9es sont saisies et centralis\u00e9es dans une base de donn\u00e9es \u00e9lectronique (eCRF de l\u2019\u00e9tude). 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