{"id":3874,"date":"2017-05-24T11:03:36","date_gmt":"2017-05-24T09:03:36","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=3874"},"modified":"2025-05-21T10:44:33","modified_gmt":"2025-05-21T08:44:33","slug":"lecrf-un-outil-essentiel-pour-les-arc","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/lecrf-un-outil-essentiel-pour-les-arc\/","title":{"rendered":"l&rsquo;e-CRF : un outil essentiel et incontournable pour les ARC"},"content":{"rendered":"<p><em>Article r\u00e9dig\u00e9 par la Soci\u00e9t\u00e9 Pharmaspecific, sp\u00e9cialiste en recherche clinique<\/em><\/p>\n<p style=\"text-align: justify;\">Les \u00e9tudes cliniques permettent de d\u00e9velopper des connaissances biologiques et m\u00e9dicales dont la finalit\u00e9 est l\u2019am\u00e9lioration de la sant\u00e9 chez l\u2019homme. Il existe plusieurs types d\u2019\u00e9tudes\u00a0: interventionnelles, interventionnelles \u00e0 risques et contraintes minimes, non interventionnelles. Il existe \u00e9galement diff\u00e9rentes phases d\u2019\u00e9tudes\u00a0: pr\u00e9clinique, phase I, phase II, phase III, phase IV et post-marketing. L&rsquo;eCRF (Cahier d&rsquo;observation \u00e9lectronique)\u00a0est un outil essentiel pour les ARC. On t&rsquo;explique pourquoi.<\/p>\n<p style=\"text-align: justify;\"><em><strong>Article r\u00e9dig\u00e9 par H\u00e9di Selmi<\/strong><\/em><\/p>\n<p style=\"text-align: justify;\"><!--more--><\/p>\n<p style=\"text-align: justify;\">Lors d\u2019une \u00e9tude clinique, une quantit\u00e9 importante de donn\u00e9es vont \u00eatre recueillies, qui serviront aux diff\u00e9rentes analyses statistiques et feront preuve de qualit\u00e9.<\/p>\n<p style=\"text-align: justify;\">Ces donn\u00e9es doivent \u00eatre saisies, contr\u00f4l\u00e9es, valid\u00e9es et stock\u00e9es dans une base de donn\u00e9es.<\/p>\n<p style=\"text-align: justify;\">Ces diff\u00e9rentes \u00e9tapes n\u00e9cessitent une importante logistique et doit se faire dans le respect des bonnes pratiques cliniques (les BPC) et de la r\u00e8glementation concernant la protection des personnes.<\/p>\n<p style=\"text-align: justify;\">Le CRF (Case Report Form), qui peut \u00eatre sous forme papier ou \u00e9lectronique (on parle alors d\u2019e-CRF) va permettre de saisir ces donn\u00e9es.<\/p>\n<p style=\"text-align: justify;\">Avec le temps, le CRF papier est de moins en moins utilis\u00e9, pour laisser place \u00e0 l\u2019e-CRF. Pourquoi\u00a0? Voici la r\u00e9ponse.<\/p>\n<p style=\"text-align: justify;\">L\u2019utilisation d\u2019une base de donn\u00e9es centralis\u00e9e et d\u2019un formulaire \u00e9lectronique de recueil de donn\u00e9es, par internet, pr\u00e9sente de nombreux avantages, non n\u00e9gligeables. En effet, cela va permettre d\u2019allier simplicit\u00e9, technologie, confidentialit\u00e9 et s\u00e9curit\u00e9 des donn\u00e9es.<\/p>\n<p style=\"text-align: justify;\">La saisie des donn\u00e9es sur e-CRF va permettre\u00a0:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Acc\u00e9l\u00e9rer et simplifier le recueil, la validation et le traitement des donn\u00e9es.<\/li>\n<li>Am\u00e9liorer la qualit\u00e9 des donn\u00e9es par des contr\u00f4les.<\/li>\n<li>Permettre le suivi en continu par les ARC moniteurs et le promoteur.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">En plus de ces diff\u00e9rents avantages, l\u2019e-CRF va \u00e9galement permettre de r\u00e9duire consid\u00e9rablement la logistique et le co\u00fbt d\u2019une \u00e9tude clinique\u00a0: ce qui est important dans le d\u00e9veloppement pharmaceutique et clinique.<\/p>\n<p style=\"text-align: justify;\">D\u2019autres part, l\u2019e-CRF va permettre d\u2019optimiser les visites sur site, gr\u00e2ce \u00e0 la possibilit\u00e9 d\u2019une pr\u00e9paration en amont\u00a0: en effet, les donn\u00e9es sont accessibles par internet (tout en \u00e9tant s\u00e9curis\u00e9) par l\u2019ARC moniteur, qui peut d\u00e9j\u00e0 avoir un premier aper\u00e7u de la qualit\u00e9 des donn\u00e9es recueillies. Cela nous am\u00e8nera \u00e0 parler du \u00ab\u00a0<a href=\"https:\/\/blogdelarechercheclinique.com\/en\/remote-monitoring\/\">Remote monitoring<\/a>\u00a0\u00bb<\/p>\n<p style=\"text-align: justify;\">Ainsi, le contr\u00f4le en amont des donn\u00e9es va permettre une meilleure qualit\u00e9 des donn\u00e9es.<\/p>\n<p style=\"text-align: justify;\">Mais, avant la qualit\u00e9, il est important de penser \u00e0 la s\u00e9curit\u00e9. En effet, l\u2019eCRF va permettre un acc\u00e8s restreint aux donn\u00e9es (acc\u00e8s par mot de passe, donn\u00e9es crypt\u00e9es, protocole s\u00e9curis\u00e9) et donc garantir la confidentialit\u00e9 et la s\u00e9curit\u00e9.<\/p>\n<p style=\"text-align: justify;\">Par ailleurs, cela va r\u00e9duire la charge de travail, gr\u00e2ce \u00e0 la possibilit\u00e9 d\u2019un contr\u00f4le automatis\u00e9 des donn\u00e9es pendant leur saisie (on parle de Queries automatiques). La double saisie des donn\u00e9es n\u2019est donc plus n\u00e9cessaire\u00a0!<\/p>\n<p style=\"text-align: justify;\">D\u2019autres part, les e-CRF permettent d\u2019int\u00e9grer des fonctionnalit\u00e9s indispensables \u00e0 l\u2019\u00e9tude comme par exemple une randomisation automatis\u00e9e, s\u00e9curis\u00e9e qui va permettre d\u2019\u00e9quilibrer les groupes de patients en temps r\u00e9el. D\u2019autres fonctionnalit\u00e9s comme des alertes en temps r\u00e9el des EIG, d\u00e9viation au protocole (par mail ou SMS) vont permettre une meilleure r\u00e9activit\u00e9 du promoteur.<\/p>\n<p style=\"text-align: justify;\">Enfin, l\u2019e-CRF va permettre de centraliser toutes les donn\u00e9es, et ainsi faciliter leur traitement.<\/p>\n<p style=\"text-align: justify;\">Ah, la technologie \u2026<\/p>\n<hr \/>\n<p style=\"text-align: center;\"><strong>Vous avez besoin d&rsquo;une prestation en recherche clinique ? contactez PHARMASPECIFIC en vous rendant sur notre site en cliquant ici : <a href=\"https:\/\/pharmaspecific.com\/devis\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/pharmaspecific.com\/devis\/<\/a><\/strong><\/p>\n<p style=\"text-align: center;\"><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 style=\"text-align: center;\"><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\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/pharmaspecific-training.com\/<\/a><\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>Article r\u00e9dig\u00e9 par la Soci\u00e9t\u00e9 Pharmaspecific, sp\u00e9cialiste en recherche clinique Les \u00e9tudes cliniques permettent de d\u00e9velopper des connaissances&#8230;<\/p>","protected":false},"author":4,"featured_media":3876,"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":[450],"tags":[16,294,8],"class_list":{"0":"post-3874","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-actualites-de-la-recherche-clinique","8":"tag-arc","9":"tag-ecrf","10":"tag-recherche-clinique"},"translation":{"provider":"WPGlobus","version":"3.0.2","language":"en","enabled_languages":["fr","en"],"languages":{"fr":{"title":true,"content":true,"excerpt":false},"en":{"title":false,"content":false,"excerpt":false}}},"yoast_head":"<!-- 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Ou tu as simplement envie d\u2019avoir une vision simple et globale de la typologie actuelle des \u00e9tudes en recherche clinique\u00a0? 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Cependant, cette pr\u00e9occupation s'\u00e9tend \u00e9galement aux investigateurs et aux promoteurs.","rel":"","context":"In &quot;Actualit\u00e9s de la recherche clinique&quot;","block_context":{"text":"Actualit\u00e9s de la recherche clinique","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/actualites-de-la-recherche-clinique\/"},"img":{"alt_text":"Etat actuel, objectifs et principaux changements","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/03\/MAJ-GCP.png?fit=1080%2C1080&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/03\/MAJ-GCP.png?fit=1080%2C1080&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/03\/MAJ-GCP.png?fit=1080%2C1080&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/03\/MAJ-GCP.png?fit=1080%2C1080&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/03\/MAJ-GCP.png?fit=1080%2C1080&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":13915,"url":"https:\/\/blogdelarechercheclinique.com\/en\/points-importants-du-nouveau-reglement-europeen-2014\/","url_meta":{"origin":3874,"position":5},"title":"Les points importants du nouveau r\u00e8glement europ\u00e9en de 2014","author":"Vanessa Montanari","date":"25 November 2015","format":false,"excerpt":"Te souviens-tu que l\u2019ann\u00e9e derni\u00e8re, la Directive Europ\u00e9enne de 2001 (2001\/20\/CE) avait \u00e9t\u00e9 abrog\u00e9e par le r\u00e8glement europ\u00e9en de 2014\u00a0? Ce nouveau r\u00e8glement, applicable aux essais cliniques de m\u00e9dicaments \u00e0 usage humain, entrera en application en 2016. 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