{"id":2432,"date":"2018-12-17T10:13:31","date_gmt":"2018-12-17T09:13:31","guid":{"rendered":"https:\/\/triton.u707.jussieu.fr\/hepatherWPpreprod\/?page_id=2432"},"modified":"2019-05-27T13:34:22","modified_gmt":"2019-05-27T11:34:22","slug":"documentation","status":"publish","type":"page","link":"https:\/\/triton.iplesp.upmc.fr\/hepather_ANRS\/la-cohorte\/documentation\/","title":{"rendered":"Documentation"},"content":{"rendered":"\n<p>Protocole : <a href=\"https:\/\/triton.u707.jussieu.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/02\/Protocole_ANRSCO22_Hepather.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">Protocole ANRS CO22 Hepather du 04\/12\/2018<\/a><\/p>\n\n\n\n<p>Comit\u00e9 consultatif sur le traitement de l&rsquo;information en mati\u00e8re de recherche dans le domaine de la sant\u00e9 : <a href=\"https:\/\/triton.u707.jussieu.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/01\/CCTIRS_avis_initial.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">Avis initial<\/a><\/p>\n\n\n\n<p>Autorisation de la CNIL : <a href=\"https:\/\/triton.u707.jussieu.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/01\/CNIL_avis_initial.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">D\u00e9cision DR-2013-611<\/a><\/p>\n\n\n\n<p>Autorisation de la CNIL : <a href=\"https:\/\/triton.u707.jussieu.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/01\/CNIL_autorisation_SNDS.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">D\u00e9lib\u00e9ration n\u00b0 2018-300 du 19 juillet 2018<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/triton.iplesp.upmc.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/05\/Cahier_des_variables_Hepather.xlsx\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Cahier des variables (opens in a new tab)\">Cahier des variables<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/triton.iplesp.upmc.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/05\/Hepather-CRF-annote.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"CRF annnot\u00e9\n (opens in a new tab)\">CRF annnot\u00e9<br><\/a><\/p>\n\n\n\n<p>Compte-rendu d&rsquo;\u00e9valuation de l&rsquo;ANR<\/p>\n\n\n\n<p>Etude enregistr\u00e9e sur le site de ClinicalTrials.gov :<br><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01953458?term=hepather&amp;rank=1\" target=\"_blank\" rel=\"noopener noreferrer\">\ufeffTherapeutic Option for Hepatitis B and C : a French Cohort (HEPATHER)<\/a><br><\/p>\n\n\n\n<p>Autorisations d&rsquo;essai clinique ne portant pas sur un produit de sant\u00e9 :<br><a href=\"https:\/\/triton.u707.jussieu.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/01\/ANSM_avis_1_initial.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">Avis initial <\/a><\/p>\n\n\n\n<p>Autorisation de modifications substancielles d&rsquo;essais cliniques ne portant pas sur un produit de sant\u00e9 :<br><a href=\"https:\/\/triton.u707.jussieu.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/01\/ANSM_avis_2.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">Avis 2<\/a><\/p>\n\n\n\n<p>Autorisation de modifications substancielles d&rsquo;essais cliniques ne portant pas sur un produit de sant\u00e9 :<br><a href=\"https:\/\/triton.u707.jussieu.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/01\/ANSM_avis_3.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">Avis 3<\/a><\/p>\n\n\n\n<p>Autorisation de modifications substancielles d&rsquo;essais cliniques ne portant pas sur un produit de sant\u00e9 :<br><a href=\"https:\/\/triton.u707.jussieu.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/01\/ANSM_avis_4.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">Avis 4<\/a><\/p>\n\n\n\n<p>Autorisation de modifications substancielles d&rsquo;essais cliniques ne portant pas sur un produit de sant\u00e9 :<br><a href=\"https:\/\/triton.u707.jussieu.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/01\/ANSM_avis_5.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">Avis 5<\/a><\/p>\n\n\n\n<p>Autorisation de modifications substancielles d&rsquo;essais cliniques ne portant pas sur un produit de sant\u00e9 :<br><a href=\"https:\/\/triton.u707.jussieu.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/01\/ANSM_avis_6.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">Avis 6<\/a><\/p>\n\n\n\n<p>Autorisation de modifications substancielles d&rsquo;essais cliniques ne portant pas sur un produit de sant\u00e9 :<br><a href=\"https:\/\/triton.u707.jussieu.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/01\/ANSM_avis_7.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">Avis 7<\/a><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Protocole : Protocole ANRS CO22 Hepather du 04\/12\/2018 Comit\u00e9 consultatif sur le traitement de l&rsquo;information en mati\u00e8re de recherche dans le domaine de la sant\u00e9 : Avis initial Autorisation de la CNIL : D\u00e9cision DR-2013-611 Autorisation de la CNIL : D\u00e9lib\u00e9ration n\u00b0 2018-300 du 19 juillet 2018 Cahier des variables CRF annnot\u00e9 Compte-rendu d&rsquo;\u00e9valuation de [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":158,"menu_order":5,"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-2432","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Documentation - 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\/documentation\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" 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Cr\u00e9\u00e9e le 17 novembre 1975, l\u2019AFEF a obtenu le statut d\u2019association reconnue d\u2019utilit\u00e9 publique le 6 janvier 2005.\u2026","rel":"","context":"Article similaire","block_context":{"text":"Article similaire","link":""},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":171,"url":"https:\/\/triton.iplesp.upmc.fr\/hepather_ANRS\/la-cohorte\/la-gouvernance\/","url_meta":{"origin":2432,"position":1},"title":"La gouvernance","author":"admin_fchau","date":"24 janvier 2018","format":false,"excerpt":"La gouvernance a pour mission de donner un avis sur toute question relative \u00e0 la d\u00e9ontologie, de d\u00e9finir ce qui peut constituer un conflit d\u2019int\u00e9r\u00eat, d'\u00e9valuer les dispositifs de gestion des liens d\u2019int\u00e9r\u00eat, d'\u00e9valuer les refus d\u2019acc\u00e8s \u00e0 la cohorte et de faire des recommandations pour am\u00e9liorer les r\u00e8gles d\u00e9ontologiques\u2026","rel":"","context":"Article similaire","block_context":{"text":"Article similaire","link":""},"img":{"alt_text":"gouvernance","src":"https:\/\/i0.wp.com\/triton.iplesp.upmc.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/02\/gouvernance-1024x567.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/triton.iplesp.upmc.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/02\/gouvernance-1024x567.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/triton.iplesp.upmc.fr\/hepather_ANRS\/wp-content\/uploads\/2019\/02\/gouvernance-1024x567.png?resize=525%2C300&ssl=1 1.5x"},"classes":[]},{"id":793,"url":"https:\/\/triton.iplesp.upmc.fr\/hepather_ANRS\/articles\/","url_meta":{"origin":2432,"position":2},"title":"Articles","author":"admin_ft","date":"18 octobre 2018","format":false,"excerpt":"\"HEPATHER : premi\u00e8re cohorte de l\u2019INSERM \u00e0 obtenir l\u2019autorisation de la commission nationale informatique et libert\u00e9 (CNIL) pour le cha\u00eenage avec le Syst\u00e8me National des Donn\u00e9es de Sant\u00e9 (SNDS)\" \u00ab\u00a0HEPATHER, source de donn\u00e9es pour une \u00e9tude command\u00e9e par la Haute Autorit\u00e9 de Sant\u00e9 concernant l\u2019efficacit\u00e9 virologique et la s\u00e9curit\u00e9 des\u2026","rel":"","context":"Article similaire","block_context":{"text":"Article similaire","link":""},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":1058,"url":"https:\/\/triton.iplesp.upmc.fr\/hepather_ANRS\/la-cohorte\/description-de-la-cohorte\/ethique\/","url_meta":{"origin":2432,"position":3},"title":"Ethique","author":"admin_ft","date":"23 octobre 2018","format":false,"excerpt":"Le suivi clinique est r\u00e9alis\u00e9 dans le cadre du soin et articul\u00e9 avec le dossier m\u00e9dical du patient. Un recueil actif des \u00e9v\u00e9nements cliniques ou des modifications th\u00e9rapeutiques sera effectu\u00e9. Un syst\u00e8me d'information s\u00e9curis\u00e9 et r\u00e9pondant aux exigences r\u00e8glementaires de la CNIL sera d\u00e9ploy\u00e9 \u00e0 cet effet. Par ailleurs, sont\u2026","rel":"","context":"Article similaire","block_context":{"text":"Article similaire","link":""},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":1754,"url":"https:\/\/triton.iplesp.upmc.fr\/hepather_ANRS\/la-cohorte\/description-de-la-cohorte\/circuit-de-donnees\/","url_meta":{"origin":2432,"position":4},"title":"Circuit de donn\u00e9es","author":"admin_ft","date":"8 novembre 2018","format":false,"excerpt":"Un formulaire \u00e9lectronique \u2013 eCRF - est d\u00e9velopp\u00e9 par l'Institut Pierre Louis d'Epid\u00e9miologie et de Sant\u00e9 Publique \u2013 iPLESP \u2013 UMRS 1136 et permet \u00e0 chaque centre clinique la saisie en ligne des donn\u00e9es d'inclusion et de suivi pour chaque patient. Ces donn\u00e9es sont centralis\u00e9es sur serveur conform\u00e9ment aux exigences\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":2432,"position":5},"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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