{"id":6523,"date":"2020-01-27T18:00:59","date_gmt":"2020-01-27T17:00:59","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=6523"},"modified":"2025-05-23T16:44:24","modified_gmt":"2025-05-23T14:44:24","slug":"fraud-clinical-trials","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/fraud-clinical-trials\/","title":{"rendered":"Challenge #26 : Fraud in clinical trials, what to do?"},"content":{"rendered":"<p>Challenge #26 : Fraud in clinical trials, what to do?<\/p>\n<p>This year will be a year of meeting, sharing, knowledge and development. Are you ready with us It will start with our 2020 challenge, one video per day for 30 days on monitoring.<br \/>\nFor 30 days, we will give you high added value content for quality monitoring!<\/p>\n<p><!--more--><\/p>\n<p>Join us on Instagram by clicking here: <a href=\"https:\/\/www.instagram.com\/blogrechercheclinique\/\">https:\/\/www.instagram.com\/blogrechercheclinique\/<\/a><br \/>\nDo you need clinical research? contact PHARMASPECIFIC by going to our site by clicking here: <a href=\"https:\/\/pharmaspecific.com\/devis\/\">https:\/\/pharmaspecific.com\/devis\/<\/a><br \/>\nIf you have any questions about the profession of clinical research associate or a career in clinical research, you can put it in the comments below. We will get back to you as soon as possible.<\/p>\n<p><iframe data-src=\"https:\/\/www.youtube.com\/embed\/IhD1AS39w3E\" 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>Good morning, everyone. This is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we&rsquo;re going to look at a new topic. The consent was signed by the patient and the handwriting, for example, the date is not the same as the patient&rsquo;s. In other words, you&rsquo;re going to have two different handwritings, two different colours of pens that lead you to think that it&rsquo;s not the patient who completed some of the information.<\/p>\n<p><!--more--><\/p>\n<p>So what do you do when this kind of thing happens? You can be a little bit confused because you don&rsquo;t expect that kind of thing. In fact it can happen, it&rsquo;s quite rare, but it can happen that the information has been missed by the investigator and that someone then passes on the briefing notes. Then, the person may not pay attention and wrote it down with another pen or it&rsquo;s going to be written down or it&rsquo;s a different handwriting. So when you find yourself in that situation, you&rsquo;re embarrassed. So the first thing to do is not to go to the investigator to tell you I think there may be fraud somewhere. The first thing to do is that you should contact your project manager to discuss it, explain what you saw and then discuss it with people above you. You can&rsquo;t make this kind of decision alone and you have to wait before talking about what you&rsquo;ve found. If you have any doubts, as you normally know in every company, there are procedures for managing <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>fraud in clinical trials<\/strong><\/a>. So you have to use this internal procedure as well, which explains how you should proceed if you see something like this. Your role as a clinical research associate is also to be able to identify this type of thing because fraud exists. This video is very short because there&rsquo;s very little that can be done about it.<\/p>\n<p>I hope it has helped you. If you want to know more about clinical research, you can go to the clinical research blog. The URL is here. If you liked this video, you can put I like at the bottom of the video. If you want to know more about Pharmaspecific our <a href=\"https:\/\/www.pharmaspecific.com\"><strong>CRO specialized in clinical research<\/strong><\/a>? The link is here. We have created a guide of a hundred pages that is a feedback from our team. If you want to download it, you can do so. The link is at the bottom of the video. Thank you for following us and see you soon.<\/p>\n<p>Goodbye, see you soon.<\/p>","protected":false},"excerpt":{"rendered":"<p>The consent was signed by the patient and the handwriting, for example, the date is not the same as the patient&rsquo;s. In other words, you&rsquo;re going to have two different handwritings, two different colours of pens that lead you to think that it&rsquo;s not the patient who completed some of the information.<\/p>","protected":false},"author":4,"featured_media":14123,"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":[882],"tags":[66,41,155,8],"class_list":{"0":"post-6523","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-practice-the-profession-cra","8":"tag-attache-de-recherche-clinique","9":"tag-cro","10":"tag-etude-clinique","11":"tag-recherche-clinique"},"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>Challenge #26 : Fraud in clinical trials, what to do?<\/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\/fraud-clinical-trials\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Challenge #26 : Fraud in clinical trials, what to do? 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C'est-\u00e0-dire que vous allez avoir deux \u00e9critures, deux couleurs de stylos diff\u00e9rentes qui vous portent \u00e0 penser que ce n'est pas le patient qui a compl\u00e9t\u00e9 une partie\u2026","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":"Challenge #26","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/video-fraude.png?fit=553%2C311&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/video-fraude.png?fit=553%2C311&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/video-fraude.png?fit=553%2C311&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":6426,"url":"https:\/\/blogdelarechercheclinique.com\/en\/person-signed-consent-resident-physician\/","url_meta":{"origin":6523,"position":1},"title":"Challenge #11 The person who signed the consent is a resident physician. What to do?","author":"Vanessa Montanari","date":"12 January 2020","format":false,"excerpt":"The person who signed the consent is a resident physician. What to do?","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":"Consentement \u00e9clair\u00e9 sign\u00e9 par un interne.","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/consentement-eclaire-interne.png?fit=555%2C307&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/consentement-eclaire-interne.png?fit=555%2C307&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/consentement-eclaire-interne.png?fit=555%2C307&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":6397,"url":"https:\/\/blogdelarechercheclinique.com\/en\/adverse-events-medical-file\/","url_meta":{"origin":6523,"position":2},"title":"Challenge # 7 No adverse events grade and no link to the product under study in the medical file. What to do?","author":"Vanessa Montanari","date":"8 January 2020","format":false,"excerpt":"No adverse events grade and no link to the product under study in the medical file. What to do?","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":"Adverse events","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/adverse-event.png?fit=555%2C312&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/adverse-event.png?fit=555%2C312&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/adverse-event.png?fit=555%2C312&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":6439,"url":"https:\/\/blogdelarechercheclinique.com\/en\/monitoring-visit-investigator-binder\/","url_meta":{"origin":6523,"position":3},"title":"Challenge # 14 Monitoring visit: The investigator site file, What to check?","author":"Vanessa Montanari","date":"20 January 2020","format":false,"excerpt":"We're going to talk about managing the investigator binder. How do you manage the Investigator's Workbook? 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":6532,"url":"https:\/\/blogdelarechercheclinique.com\/en\/patient-enrolled-criteria\/","url_meta":{"origin":6523,"position":4},"title":"Challenge #27: My patient was enrolled, he did not have the criteria, what should I do?","author":"Vanessa Montanari","date":"28 January 2020","format":false,"excerpt":"Hello everyone, this is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we're going to look at a new topic. The patient was included when he didn't meet the criteria. That's something that can happen. Something that's pretty rare, but it can happen. 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