{"id":14350,"date":"2024-06-10T09:27:57","date_gmt":"2024-06-10T07:27:57","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=14350"},"modified":"2024-06-10T09:34:31","modified_gmt":"2024-06-10T07:34:31","slug":"tec-obligations-rgpd","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/tec-obligations-rgpd\/","title":{"rendered":"TEC : Mise en place des obligations li\u00e9es au RGPD"},"content":{"rendered":"<p><iframe data-src=\"https:\/\/www.youtube.com\/embed\/YGgTxDIRerY\" 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\u2019est Manon DURAND, juriste sant\u00e9 au sein de l\u2019entreprise Pharmaspecific.<\/p>\n<p>On se retrouve aujourd\u2019hui une nouvelle fois pour parler du RGPD, le R\u00e8glement G\u00e9n\u00e9ral sur la Protection des Donn\u00e9es. Je vous rappelle, ce texte sert de r\u00e9f\u00e9rence en mati\u00e8re de protection des donn\u00e9es \u00e0 caract\u00e8re personnel au sein de l\u2019UE. Il est entr\u00e9 en application le 25 mai 2018 dans les Etats membres de l\u2019UE.<\/p>\n<h2>Le TEC est-il responsable de la mise en place des obligations li\u00e9es au RGPD<\/h2>\n<p>La question du jour est celle de savoir si les techniciens d\u2019\u00e9tude clinique (les TEC) sont responsables, \u00e0 leur niveau, de mettre en place <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>les obligations li\u00e9es au RGPD<\/strong><\/a> ou alors si cela se passe \u00e0 un autre niveau. Pour rappel, les techniciens d\u2019\u00e9tude clinique, c\u2019est le personnel qui va \u00eatre <strong>charg\u00e9 de la saisie des donn\u00e9es de l\u2019\u00e9tude<\/strong> qui sont recueillies aupr\u00e8s des patients pour mettre en place le bon d\u00e9roul\u00e9 de l\u2019\u00e9tude. Ils sont confront\u00e9s de mani\u00e8re quotidienne aux donn\u00e9es \u00e0 caract\u00e8re personnel. Toutefois, ce n\u2019est pas \u00e0 eux de <a href=\"https:\/\/pharmaspecific.com\/service\/delegue-a-la-protection-des-donnees\">mettre en place les obligations li\u00e9es au RPGD<\/a> puisque cela se passe au niveau du responsable de traitement.<\/p>\n<p>Je vous le rappelle, le responsable de traitement, c\u2019est la personne qui d\u00e9termine les finalit\u00e9s et les moyens du traitement. En pratique dans la recherche clinique, c\u2019est le promoteur. Au sein de l\u2019organisme du promoteur, il y a diff\u00e9rents niveaux qui peuvent s\u2019occuper de la conformit\u00e9 RGPD.<\/p>\n<h2>A quel niveau, le TEC est-il responsable de la mise en place de ces obligations.<\/h2>\n<p>D\u2019abord, si un d\u00e9l\u00e9gu\u00e9 \u00e0 la protection des donn\u00e9es a \u00e9t\u00e9 d\u00e9sign\u00e9 &#8211; ce qui n\u2019est pas toujours une obligation &#8211; si un d\u00e9l\u00e9gu\u00e9 \u00e0 la protection des donn\u00e9es a \u00e9t\u00e9 d\u00e9sign\u00e9, c\u2019est lui qui va s\u2019occuper de <strong>la conformit\u00e9 au RGPD<\/strong>, c\u2019est-\u00e0-dire, mettre en place tous les outils requis, les registres de traitement, l\u2019analyse d\u2019impact le cas \u00e9ch\u00e9ant, l\u2019encadrement des transferts en dehors de l\u2019UE etc.<\/p>\n<p>S\u2019il n\u2019y a pas de DPO dans l\u2019organisme du promoteur, cela va se passer soit au niveau du service juridique s\u2019il y en a un et sinon directement au niveau de la direction. Ce n\u2019est donc pas aux <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/comment-ameliorer-la-reconnaissance-du-metier-de-tec\/\">techniciens d\u2019\u00e9tude clinique<\/a> de mettre en place la conformit\u00e9 RGPD. En revanche, ils doivent, comme tout le personnel impliqu\u00e9 dans l\u2019\u00e9tude, \u00eatre form\u00e9s aux r\u00e8gles du RGPD, \u00e0 son esprit et \u00e0 la mani\u00e8re dont les donn\u00e9es doivent \u00eatre trait\u00e9es puisqu\u2019ils sont confront\u00e9s de mani\u00e8re quotidienne a ces donn\u00e9es, ils doivent pouvoir savoir ce qu\u2019ils peuvent ou non faire sur les donn\u00e9es.<\/p>\n<p>Voil\u00e0 j\u2019esp\u00e8re que cette vid\u00e9o vous aura plu, si c\u2019est le cas vous pouvez vous abonner \u00e0 notre chaine et aimer cette vid\u00e9os et vous trouverez en barre d\u2019information toutes les informations concernant nos prestations qu\u2019il s\u2019agisse de la veille juridique mensuelle ou du conseil juridique en recherche clinique, quant \u00e0 nous, on se retrouve bient\u00f4t pour une nouvelle vid\u00e9o\u00a0!<\/p>\n<p>www.pharmaspecific-training.com<\/p>","protected":false},"excerpt":{"rendered":"<p>On se retrouve aujourd\u2019hui une nouvelle fois pour parler du RGPD, le R\u00e8glement G\u00e9n\u00e9ral sur la Protection des Donn\u00e9es. Je vous rappelle, ce texte sert de r\u00e9f\u00e9rence en mati\u00e8re de protection des donn\u00e9es \u00e0 caract\u00e8re personnel au sein de l\u2019UE. Il est entr\u00e9 en application le 25 mai 2018 dans les Etats membres de l\u2019UE.<\/p>","protected":false},"author":4,"featured_media":14352,"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":[],"class_list":{"0":"post-14350","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-reglementaires"},"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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Il s'agit du texte de r\u00e9f\u00e9rence en mati\u00e8re de protection des donn\u00e9es \u00e0 caract\u00e8re personnel. Le RGPD est entr\u00e9 en application le 25 mai 2018 dans les Etats membres de l\u2019UE.","rel":"","context":"In &quot;Les r\u00e8glementaires&quot;","block_context":{"text":"Les r\u00e8glementaires","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/reglementaires\/"},"img":{"alt_text":"Anonymisation et RGPD","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2021\/04\/Anonymisation-RGPD.jpg?fit=450%2C300&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":11674,"url":"https:\/\/blogdelarechercheclinique.com\/en\/designer-dpo-dehors-union-europeenne\/","url_meta":{"origin":14350,"position":1},"title":"Peut-on designer un DPO en dehors de l&rsquo;Union Europ\u00e9enne?","author":"Vanessa Montanari","date":"21 April 2021","format":false,"excerpt":"Est-il possible de designer un DPO en dehors de l'Union Europ\u00e9en? Comment designer son DPO en dehors de l'Union Europ\u00e9en.","rel":"","context":"In &quot;Les r\u00e8glementaires&quot;","block_context":{"text":"Les r\u00e8glementaires","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/reglementaires\/"},"img":{"alt_text":"Designer un DPO hors UE","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2021\/04\/Outside-UE.png?fit=1138%2C562&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2021\/04\/Outside-UE.png?fit=1138%2C562&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2021\/04\/Outside-UE.png?fit=1138%2C562&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2021\/04\/Outside-UE.png?fit=1138%2C562&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2021\/04\/Outside-UE.png?fit=1138%2C562&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":6007,"url":"https:\/\/blogdelarechercheclinique.com\/en\/journee-type-technicien-etude-clinique\/","url_meta":{"origin":14350,"position":2},"title":"La journ\u00e9e type d&rsquo;un technicien de recherche clinique","author":"Vanessa Montanari","date":"6 February 2019","format":false,"excerpt":"Tu es jeune dipl\u00f4m\u00e9(e) ou en reconversion professionnelle et tu d\u00e9bute ou te destine \u00e0 une carri\u00e8re de Technicien(ne) d\u2019Etudes Cliniques (TEC), tu ne sais pas \u00e0 quoi t\u2019attendre et tu te demandes \u00e0 quoi va ressembler tes journ\u00e9es\u00a0?","rel":"","context":"In &quot;Pratiquer le m\u00e9tier d'Attach\u00e9 de recherche clinique&quot;","block_context":{"text":"Pratiquer le m\u00e9tier d'Attach\u00e9 de recherche clinique","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/pratiquer-le-metier-dattache-de-recherche-clinique\/"},"img":{"alt_text":"Journ\u00e9e d'un TEC","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2019\/02\/To-do-list.png?fit=745%2C492&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2019\/02\/To-do-list.png?fit=745%2C492&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2019\/02\/To-do-list.png?fit=745%2C492&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2019\/02\/To-do-list.png?fit=745%2C492&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":14387,"url":"https:\/\/blogdelarechercheclinique.com\/en\/dpo-delegue-protection-donnees\/","url_meta":{"origin":14350,"position":3},"title":"Comment \u00eatre DPO (d\u00e9l\u00e9gu\u00e9 \u00e0 la protection des donn\u00e9es)?","author":"Vanessa Montanari","date":"10 June 2024","format":false,"excerpt":"La question du jour est celle de savoir comment devenir DPO. Pour rappel, le DPO ou d\u00e9l\u00e9gu\u00e9 \u00e0 la protection des donn\u00e9es, data protection officer, c\u2019est la personne qui va s\u2019occuper de la conformit\u00e9 de l\u2019entreprise qui l\u2019a d\u00e9sign\u00e9 au RGPD. C\u2019est-\u00e0-dire que c\u2019est lui qui va mettre en place\u2026","rel":"","context":"In &quot;Les r\u00e8glementaires&quot;","block_context":{"text":"Les r\u00e8glementaires","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/reglementaires\/"},"img":{"alt_text":"D\u00e9l\u00e9gu\u00e9 \u00e0 la protection des donn\u00e9es","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/DPO.png?fit=552%2C308&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/DPO.png?fit=552%2C308&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/DPO.png?fit=552%2C308&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":12917,"url":"https:\/\/blogdelarechercheclinique.com\/en\/mise-a-jour-good-clinical-practice-ich-e6-r3\/","url_meta":{"origin":14350,"position":4},"title":"Mise \u00e0 jour du document Good Clinical Practice ICH E6 (R3) : Etat actuel, objectifs et principaux changements","author":"Vanessa Montanari","date":"18 March 2024","format":false,"excerpt":"Vous devez suivre une formation aux Bonnes Pratiques Cliniques li\u00e9e \u00e0 l'exercice de la profession. 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":14360,"url":"https:\/\/blogdelarechercheclinique.com\/en\/rgpd-analyse-impact-a-posteriori\/","url_meta":{"origin":14350,"position":5},"title":"RGPD : peut-on faire une analyse d&rsquo;impact \u00e0 posteriori?","author":"Vanessa Montanari","date":"10 June 2024","format":false,"excerpt":"On se retrouve aujourd\u2019hui pour parler du R\u00e8glement G\u00e9n\u00e9ral sur la Protection des Donn\u00e9es (le RGPD). Je tiens toujours \u00e0 vous le rappeler, il s'agit du texte de r\u00e9f\u00e9rence en mati\u00e8re de protection des donn\u00e9es \u00e0 caract\u00e8re personnel. Ce texte est entr\u00e9 en application au sein de l\u2019Union Europ\u00e9enne le\u2026","rel":"","context":"In &quot;Les r\u00e8glementaires&quot;","block_context":{"text":"Les r\u00e8glementaires","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/reglementaires\/"},"img":{"alt_text":"analyse d'impact RGPD","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/analyse-dimpact-RGPD.png?fit=555%2C310&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/analyse-dimpact-RGPD.png?fit=555%2C310&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/analyse-dimpact-RGPD.png?fit=555%2C310&ssl=1&resize=525%2C300 1.5x"},"classes":[]}],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts\/14350","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/comments?post=14350"}],"version-history":[{"count":2,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts\/14350\/revisions"}],"predecessor-version":[{"id":14355,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts\/14350\/revisions\/14355"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/media\/14352"}],"wp:attachment":[{"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/media?parent=14350"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/categories?post=14350"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/tags?post=14350"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}