{"id":13926,"date":"2015-11-11T10:00:33","date_gmt":"2015-11-11T09:00:33","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=13926"},"modified":"2024-05-23T09:55:01","modified_gmt":"2024-05-23T07:55:01","slug":"mr-002-nouvelle-methode-reference-recherche-clinique","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/mr-002-nouvelle-methode-reference-recherche-clinique\/","title":{"rendered":"MR-002 : la nouvelle m\u00e9thode de r\u00e9f\u00e9rence en recherche clinique"},"content":{"rendered":"<p class=\"p1\"><span class=\"s1\"><i>Article r\u00e9dig\u00e9 par la Soci\u00e9t\u00e9 Pharmaspecific, sp\u00e9cialiste en recherche clinique<\/i><\/span><\/p>\n<h2 style=\"text-align: justify;\">Apr\u00e8s la MR-001, la MR-002\u2026<\/h2>\n<p style=\"text-align: justify;\">Dans un pr\u00e9c\u00e9dent article du blog, que tu peux retrouver <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/?s=mr+001\">ici<\/a>,\u00a0 nous t\u2019avons parl\u00e9 de la MR-001, proc\u00e9dure simplifiant la d\u00e9claration de traitement des donn\u00e9es lors de Recherches Biom\u00e9dicales \u00e0 la CNIL (Commission Nationale de l\u2019Informatique et des Libert\u00e9s). Sais-tu que cet \u00e9t\u00e9, une nouvelle m\u00e9thodologie de r\u00e9f\u00e9rence, la MR-002, a \u00e9t\u00e9 cr\u00e9\u00e9e\u00a0? Elle a \u00e9t\u00e9 publi\u00e9e au Journal Officiel le 22 ao\u00fbt dernier. Dans cet article nous allons t\u2019expliquer en quoi elle consiste.<!--more--><\/p>\n<h2 style=\"text-align: justify;\"><img data-recalc-dims=\"1\" decoding=\"async\" class=\"size-full wp-image-13927 aligncenter lazyload\" data-src=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/MR002.png?resize=738%2C656&#038;ssl=1\" alt=\"MR002: nouvelle m\u00e9thodologie de r\u00e9f\u00e9rence\" width=\"738\" height=\"656\" data-srcset=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/MR002.png?w=738&amp;ssl=1 738w, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/MR002.png?resize=300%2C267&amp;ssl=1 300w, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/MR002.png?resize=600%2C533&amp;ssl=1 600w\" data-sizes=\"(max-width: 738px) 100vw, 738px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 738px; --smush-placeholder-aspect-ratio: 738\/656;\" \/>1. Quelle(s) \u00e9tude(s) sont concern\u00e9es par la MR-002\u00a0?<\/h2>\n<p style=\"text-align: justify;\">Tout comme la MR-001, la MR-002 concerne les traitements de donn\u00e9es \u00e0 caract\u00e8re personnel. Cependant, elle ne s\u2019applique pas aux Recherches Biom\u00e9dicales (RBM) mais aux \u00e9tudes non interventionnelles de performances en mati\u00e8re de Dispositifs M\u00e9dicaux de Diagnostic In Vitro (DM-DIV).<\/p>\n<h2 style=\"text-align: justify;\">2. Un DM-DIV, c\u2019est quoi d\u00e9j\u00e0\u00a0?<\/h2>\n<p style=\"text-align: justify;\">Pour rappel, les Dispositifs M\u00e9dicaux de Diagnostic In Vitro sont\u00a0(d\u00e9finition issue de l\u2019article <a href=\"http:\/\/www.legifrance.gouv.fr\/affichCodeArticle.do?cidTexte=LEGITEXT000006072665&amp;idArticle=LEGIARTI000006690312&amp;dateTexte=&amp;categorieLien=cid\">L5221-1\u00a0<\/a>du Code de la Sant\u00e9 Publique) :<\/p>\n<blockquote>\n<p style=\"text-align: justify;\">\u00a0<em>\u00ab\u00a0<\/em><em>les produits, r\u00e9actifs, mat\u00e9riaux, instruments et syst\u00e8mes, leurs composants et accessoires, ainsi que les r\u00e9cipients pour \u00e9chantillons, destin\u00e9s sp\u00e9cifiquement \u00e0 \u00eatre utilis\u00e9s in vitro, seuls ou en combinaison, dans l&rsquo;examen d&rsquo;\u00e9chantillons provenant du corps humain, afin de fournir une information concernant un \u00e9tat physiologique ou pathologique, av\u00e9r\u00e9 ou potentiel, ou une anomalie cong\u00e9nitale, pour contr\u00f4ler des mesures th\u00e9rapeutiques, ou pour d\u00e9terminer la s\u00e9curit\u00e9 d&rsquo;un pr\u00e9l\u00e8vement d&rsquo;\u00e9l\u00e9ments du corps humain ou sa compatibilit\u00e9 avec des receveurs potentiels<\/em>\u00a0\u00bb<\/p>\n<\/blockquote>\n<p style=\"text-align: justify;\">On peut citer comme exemples\u00a0\u00a0de DM-DIV\u00a0: autotests, marqueurs tumoraux, r\u00e9actifs de dosage l&rsquo;h\u00e9moglobine glyqu\u00e9e, r\u00e9actifs de dosage du cholest\u00e9rol-HDL&#8230;<\/p>\n<h2 style=\"text-align: justify;\">3. Les principes de la MR-002\u2026<\/h2>\n<p style=\"text-align: justify;\">La grande majorit\u00e9 des points \u00e9voqu\u00e9s par la MR-002 sont similaires \u00e0 ceux de la MR-001. Ils concernent\u00a0:<\/p>\n<ul style=\"text-align: justify;\">\n<li>l\u2019information des patients sur le devenir de leurs donn\u00e9es,<\/li>\n<li>l\u2019information des investigateurs et de son \u00e9quipe de recherche sur le devenir de leurs donn\u00e9es,<\/li>\n<li>le recueil du consentement du patient (retrait de l\u2019\u00e9tude, droits d\u2019acc\u00e8s et de rectification des donn\u00e9es, \u2026),<\/li>\n<li>les donn\u00e9es recueillies,<\/li>\n<li>la nature et le traitement des donn\u00e9es,<\/li>\n<li>l\u2019analyse des donn\u00e9es (les destinataires),<\/li>\n<li>les personnes ayant acc\u00e8s \u00e0 ces donn\u00e9es,<\/li>\n<li>la dur\u00e9e de conservation des donn\u00e9es,<\/li>\n<li>la s\u00e9curit\u00e9 des traitements,<\/li>\n<li>le transfert des donn\u00e9es \u00e0 l\u2019\u00e9tranger.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">Les diff\u00e9rences r\u00e9sident dans les points suivants\u00a0:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Seuls peuvent faire l\u2019objet d\u2019un engagement de conformit\u00e9 par r\u00e9f\u00e9rence \u00e0 la MR-002, les traitements ayant pour finalit\u00e9s la r\u00e9alisation d\u2019\u00e9tudes non interventionnelles de performances soumises aux dispositions des articles <a href=\"http:\/\/www.legifrance.gouv.fr\/affichCodeArticle.do?idArticle=LEGIARTI000006900785&amp;cidTexte=LEGITEXT000006072050\">L1121-1<\/a>, <a href=\"http:\/\/www.legifrance.gouv.fr\/affichCodeArticle.do?cidTexte=LEGITEXT000006072665&amp;idArticle=LEGIARTI000006686057&amp;dateTexte=&amp;categorieLien=cid\">L.1211-2<\/a>, <a href=\"http:\/\/www.legifrance.gouv.fr\/affichCodeArticle.do?idArticle=LEGIARTI000006901191&amp;cidTexte=LEGITEXT000006072050\">L.1241-1<\/a> du Code de la Sant\u00e9 Publique :<br \/>\n<em>\u00ab\u00a0<\/em><em>Nul ne peut apporter aux droits des personnes et aux libert\u00e9s individuelles et collectives de restrictions qui ne seraient pas justifi\u00e9es par la nature de la t\u00e2che \u00e0 accomplir ni proportionn\u00e9es au but recherch\u00e9\u00a0\u00bb (L.1121-1)<br \/>\n<\/em><em>\u00ab\u00a0Le pr\u00e9l\u00e8vement d&rsquo;\u00e9l\u00e9ments du corps humain et la collecte de ses produits ne peuvent \u00eatre pratiqu\u00e9s sans le consentement pr\u00e9alable du donneur. Ce consentement est r\u00e9vocable \u00e0 tout moment.\u00a0\u00bb (L.1211-2)<\/em><\/li>\n<\/ul>\n<ul style=\"text-align: justify;\">\n<li>Attention au transfert de donn\u00e9es\u00a0\u00e0 l\u2019\u00e9tranger !<br \/>\nEn effet il est indiqu\u00e9 dans l\u2019Article 7 de la MR-002 qu\u2019il est tout \u00e0 fait possible de transf\u00e9rer des donn\u00e9es anonymes ou cod\u00e9es des participants \u00e0 ce type d\u2019\u00e9tude, en dehors de l\u2019Union Europ\u00e9enne. Cependant, pour le transfert des donn\u00e9es personnelles des investigateurs et de leur \u00e9quipe, elles peuvent \u00eatre transf\u00e9r\u00e9es hors de l&rsquo;Union europ\u00e9enne, lorsque ce transfert est strictement n\u00e9cessaire \u00e0 la mise en \u0153uvre de l&rsquo;\u00e9tude non interventionnelle de performances ou \u00e0 l&rsquo;enregistrement du DM-DIV dans un pays qui le requiert selon des conditions pr\u00e9cises (Binding Corporate Rules ou BCR, clauses contractuelles types ou Safe Harbor). Cependant, rappelle-toi que le Safe Harbor a \u00e9t\u00e9 invalid\u00e9 le mois dernier. Je t\u2019invite \u00e0 lire notre pr\u00e9c\u00e9dent article portant sur ce sujet<a href=\"https:\/\/blogdelarechercheclinique.com\/en\/invalidation-safe-harbor\/#more-1459)\"> ici<\/a>.<\/li>\n<\/ul>\n<ul style=\"text-align: justify;\">\n<li>La notion de risque (Article 8)\u00a0: \u00e0 prendre en compte dans la mise en \u0153uvre et la s\u00e9curit\u00e9 des traitements de donn\u00e9es. Une politique de s\u00e9curit\u00e9 et de confidentialit\u00e9 doit alors \u00eatre mise en place par le responsable de traitement afin de pr\u00e9server la s\u00e9curit\u00e9 des donn\u00e9es trait\u00e9es\u00a0: notamment leur confidentialit\u00e9, leur int\u00e9grit\u00e9 et leur disponibilit\u00e9. Cette politique doit \u00eatre d\u00e9termin\u00e9e selon les risques, qui seront identifi\u00e9s \u00e0 la suite d\u2019une \u00e9tude des risques.Pour t\u2019aider, une grille d\u2019\u00e9tude des risques t\u2019est propos\u00e9e en Annexe 2. Elle te permettra non seulement d\u2019identifier les risques, mais aussi de prendre les mesures pour les r\u00e9duire au maximum, voire les \u00e9liminer.Les diff\u00e9rents types de risques peuvent porter\u00a0:<br \/>\n&#8211; sur les donn\u00e9es du traitement\u00a0: anonymisation des donn\u00e9es, s\u00e9curit\u00e9 des documents papier\u2026,<br \/>\n&#8211; sur le syst\u00e8me d\u2019information\u00a0: sauvegarde, maintenance, s\u00e9curit\u00e9 r\u00e9seau, contr\u00f4le d\u2019acc\u00e8s physique, profils utilisateurs, mises \u00e0 jour, antivirus, \u00e9quipements mobiles, moyens d\u2019authentification\u2026,<br \/>\n&#8211; et sur l\u2019organisation\u00a0: politique de s\u00e9curit\u00e9, gestion des risques et des incidents, gestion des personnels\u2026), engagement de conformit\u00e9\u2026)Tu peux trouver l\u2019int\u00e9gralit\u00e9 de la MR-002, et sa grille d\u2019\u00e9tude des risques, <a href=\"http:\/\/www.legifrance.gouv.fr\/affichTexte.do?cidTexte=JORFTEXT000031074605\">ici<\/a>.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">Comme tu peux le voir, le traitement des donn\u00e9es personnelles est au c\u0153ur de l\u2019actualit\u00e9 en Recherche Clinique. J\u2019esp\u00e8re que cet article t\u2019aura aid\u00e9 \u00e0 bien distinguer la MR-001 et la MR-002, qui au final, sont similaires sur de nombreux points mais s\u2019adressent \u00e0 deux types de recherches bien diff\u00e9rentes.<\/p>\n<p style=\"text-align: justify;\">Tu peux te rendre sur la page Facebook du \u00ab\u00a0Blog de la Recherche Clinique\u00a0\u00bb et de \u00ab\u00a0Pharmaspecific\u00a0\u00bb et cliquer sur \u00ab\u00a0J\u2019aime\u00a0\u00bb pour faire partie de notre cercle de professionnels.<\/p>\n<p style=\"text-align: justify;\">Retrouve\u00a0\u00ab\u00a0Pharmaspecific\u00a0\u00bb et\u00a0\u00ab\u00a0Vanessa Montanari\u00a0\u00bb \u00a0sur LinkedIn pour avoir plus d\u2019\u2019actualit\u00e9s en recherche clinique en cliquant\u00a0<a href=\"https:\/\/www.linkedin.com\/company\/pharmaspecific\/\">ici<\/a>\u00a0et\u00a0<a href=\"https:\/\/www.linkedin.com\/in\/vanessamontanari\/\">ici<br \/>\n<\/a>Retrouve nous \u00e9galement sur Viadeo en cliquant\u00a0<a href=\"http:\/\/fr.viadeo.com\/fr\/company\/pharmaspecific\">ici<\/a>\u00a0et\u00a0<a href=\"https:\/\/viadeo.journaldunet.com\/p\/vanessa-montanari-820852\">ici<\/a><\/p>\n<p style=\"text-align: justify;\">Tu peux \u00e9galement t\u2019inscrire \u00e0 la newsletter du blog, nous t\u2019informerons des nouveaux articles d\u00e8s qu\u2019ils seront post\u00e9s.<\/p>\n<hr \/>\n<p class=\"p1\" style=\"text-align: center;\"><span class=\"s1\"><b><i>Vous avez besoin d\u2019une prestation en recherche clinique? contactez PHARMASPECIFIC en vous rendant sur notre site en cliquant ici : <\/i><\/b><a href=\"https:\/\/pharmaspecific.com\/devis\"><span class=\"s2\"><b><i>https:\/\/pharmaspecific.com\/devis<\/i><\/b><\/span><\/a><\/span><\/p>\n<p class=\"p1\" style=\"text-align: center;\"><span class=\"s1\"><i>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.<\/i><\/span><\/p>\n<p class=\"p1\" style=\"text-align: center;\"><span class=\"s1\"><i>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 <\/i><a href=\"https:\/\/pharmaspecific-training.com\/\"><span class=\"s2\"><i>https:\/\/pharmaspecific-training.com\/<\/i><\/span><\/a><\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>Une nouvelle m\u00e9thodologie de r\u00e9f\u00e9rence, la MR-002, a \u00e9t\u00e9 cr\u00e9\u00e9e\u00a0? Elle a \u00e9t\u00e9 publi\u00e9e au Journal Officiel le 22 ao\u00fbt dernier. Dans cet article nous allons t\u2019expliquer en quoi elle consiste.<\/p>","protected":false},"author":4,"featured_media":13923,"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":[389],"tags":[66,145,146,203],"class_list":{"0":"post-13926","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-reglementaires","8":"tag-attache-de-recherche-clinique","9":"tag-cnil","10":"tag-mr-001","11":"tag-mr-002"},"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 - 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