{"id":11683,"date":"2021-04-21T23:01:33","date_gmt":"2021-04-21T21:01:33","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=11683"},"modified":"2025-06-12T14:49:14","modified_gmt":"2025-06-12T12:49:14","slug":"clinical-study-technicians-gdrp","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/clinical-study-technicians-gdrp\/","title":{"rendered":"Are clinical study technicians (CSTs) responsible, at their level, for implementing the obligations related to the GDPR or whether it happens at another level?"},"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>Hello everyone, this is Manon DURAND, health lawyer at Pharmaspecific. We are meeting today once again to talk about the GDPR, the General Data Protection Regulation which is, I remind you, the reference text in terms of personal data protection within the EU. It came into force on May 25, 2018 in the EU member states.<\/p>\n<p>The question of the day is whether clinical study technicians (CSTs) are responsible, at their level, for implementing the obligations related to the GDPR or whether it happens at another level. As a reminder, the clinical study technicians are the personnel who will be in charge of entering the study data that are collected from the patients in order to set up the proper conduct of the study. They are confronted with personal data on a daily basis. However, it is not up to them to implement <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>the obligations related to the GDPR<\/strong><\/a> since this happens at the level of the data controller.<\/p>\n<p>I remind you that the controller is the person who determines the purposes and means of the processing. In practice, in clinical research, it is the sponsor. Within the sponsor&rsquo;s organization, there are different levels that can deal with GDPR compliance.<\/p>\n<p>First of all, if a Data Protection Officer has been appointed &#8211; which is not always an obligation &#8211; if a Data Protection Officer has been appointed, he or she will be responsible for ensuring compliance with the DPMR, i.e., putting in place all the required tools, processing registers, impact assessment where appropriate, supervision of transfers outside the EU, etc.<\/p>\n<p>If there is no DPO in the sponsor&rsquo;s organization, it will happen either at the level of the legal department if there is one and if not directly at the management level. It is therefore not up to the clinical study technicians to implement GDPR compliance. On the other hand, they must, like all the personnel involved in the study, be trained in the <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>rules of the GDPR<\/strong><\/a>, in its spirit and in the way in which the data must be processed, since they are confronted with this data on a daily basis, they must be able to know what they can or cannot do with the data.<\/p>\n<p>I hope you enjoyed this video, if so, you can subscribe to our channel and like this video and you will find in the information bar all the information about our services such as the monthly legal watch or the legal advice in clinical research. As for us, we will soon meet again for a new video!<\/p>","protected":false},"excerpt":{"rendered":"<p>We are meeting today once again to talk about the GDPR, the General Data Protection Regulation which is, I remind you, the reference text in terms of personal data protection within the EU. It came into force on May 25, 2018 in the EU member states.<\/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":[873],"tags":[],"class_list":{"0":"post-11683","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-clinical-research-news"},"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 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Clinical study technicians take the steps related to the GDRP?<\/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:\/\/blogdelarechercheclinique.com\/en\/clinical-study-technicians-gdrp\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Are clinical study technicians (CSTs) responsible, at their level, for implementing the obligations related to the GDPR or whether it happens at another level? 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What to check?","rel":"","context":"In &quot;Jeux - \u00e9v\u00e8nements&quot;","block_context":{"text":"Jeux - \u00e9v\u00e8nements","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/jeux-evenements\/"},"img":{"alt_text":"Classeur investigateur","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/classeur-investigateur.png?fit=827%2C465&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/classeur-investigateur.png?fit=827%2C465&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/classeur-investigateur.png?fit=827%2C465&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/classeur-investigateur.png?fit=827%2C465&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":389,"url":"https:\/\/blogdelarechercheclinique.com\/en\/remote-monitoring\/","url_meta":{"origin":11683,"position":2},"title":"Remote monitoring&#8230;the evolution of the Clinical Research Associate profession (CRA)","author":"Vanessa Montanari","date":"29 October 2014","format":false,"excerpt":"The remote monitoring is a review of some data remotely, this of course implies the use of an electronic CRF (E-CRF). Once the center's staff entered the data in the e-CRF, the CRA checks their consistency and valid them as \"data reviewed.\"","rel":"","context":"In &quot;Strat\u00e9gie d'\u00e9volution pour atteindre vos objectifs&quot;","block_context":{"text":"Strat\u00e9gie d'\u00e9volution pour atteindre vos objectifs","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/strategie-devolution-pour-atteindre-vos-objectifs\/"},"img":{"alt_text":"Le remote monitoring","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/e-crf.png?fit=957%2C502&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/e-crf.png?fit=957%2C502&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/e-crf.png?fit=957%2C502&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/e-crf.png?fit=957%2C502&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":11536,"url":"https:\/\/blogdelarechercheclinique.com\/en\/invalidating-privacy-shield-clinical-researc\/","url_meta":{"origin":11683,"position":3},"title":"The earthquake:  Invalidating the Privacy Shield and clinical research (Now, what?)","author":"Vanessa Montanari","date":"22 November 2020","format":false,"excerpt":"Hello everyone, this is Manon Durand, health lawyer with Pharmaspecific. Today, we are going to talk about the protection of personal data through the invalidation of the privacy shield.","rel":"","context":"In &quot;Clinical Research News&quot;","block_context":{"text":"Clinical Research News","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/clinical-research-news\/"},"img":{"alt_text":"Privacy shield","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/invalidation-privacy-shield.png?fit=552%2C307&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/invalidation-privacy-shield.png?fit=552%2C307&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/invalidation-privacy-shield.png?fit=552%2C307&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":6507,"url":"https:\/\/blogdelarechercheclinique.com\/en\/ethnic-data-crf\/","url_meta":{"origin":11683,"position":4},"title":"Challenge #24 : Can I retrieve ethnic data from the CRF in France?","author":"Vanessa Montanari","date":"25 January 2020","format":false,"excerpt":"Are we allowed to retrieve the ethnic data from the CRF ? Then the answer to that question is yes. But it all depends on whether it's scientifically justified at the level of the research protocol, at the level of the study protocol.","rel":"","context":"In &quot;Practice the profession of Clinical Research Associate&quot;","block_context":{"text":"Practice the profession of Clinical Research Associate","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/practice-the-profession-cra\/"},"img":{"alt_text":"R\u00e9cup\u00e9rer les donn\u00e9es ethniques sur CRF","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/donnees-ethniques-CRF.png?fit=1070%2C601&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/donnees-ethniques-CRF.png?fit=1070%2C601&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/donnees-ethniques-CRF.png?fit=1070%2C601&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/donnees-ethniques-CRF.png?fit=1070%2C601&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/donnees-ethniques-CRF.png?fit=1070%2C601&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":13427,"url":"https:\/\/blogdelarechercheclinique.com\/en\/cra-and-crc-how-to-choose-the-right-job\/","url_meta":{"origin":11683,"position":5},"title":"CRA and CRC, how to choose the right Job?","author":"Vanessa Montanari","date":"7 April 2015","format":false,"excerpt":"In this article we will help you to make a choice by presenting you every type of position, missions, structures in which to apply with the carrer evolution. You could then choose knowingly :)","rel":"","context":"In &quot;Trouver un emploi en recherche clinique&quot;","block_context":{"text":"Trouver un emploi en recherche clinique","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/trouver-un-emploi-en-recherche-clinique\/"},"img":{"alt_text":"How to choose your WIP and CRA position","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/04\/choice.png?fit=1022%2C678&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/04\/choice.png?fit=1022%2C678&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/04\/choice.png?fit=1022%2C678&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/04\/choice.png?fit=1022%2C678&ssl=1&resize=700%2C400 2x"},"classes":[]}],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts\/11683","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=11683"}],"version-history":[{"count":3,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts\/11683\/revisions"}],"predecessor-version":[{"id":15037,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/posts\/11683\/revisions\/15037"}],"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=11683"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/categories?post=11683"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogdelarechercheclinique.com\/en\/wp-json\/wp\/v2\/tags?post=11683"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}