{"id":14115,"date":"2020-01-28T18:00:28","date_gmt":"2020-01-28T17:00:28","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=14115"},"modified":"2025-05-23T16:43:47","modified_gmt":"2025-05-23T14:43:47","slug":"patient-inclus-criteres","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/patient-inclus-criteres\/","title":{"rendered":"Challenge #27: My patient was enrolled, he did not have the criteria, what should I do?"},"content":{"rendered":"<p>Challenge #27: My patient was enrolled, he did not have the criteria, what should I do?<\/p>\n\n\n\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>For 30 days, we will give you high added value content for quality monitoring!<\/p>\n\n\n\n<!--more-->\n\n\n\n<p>Join us on Instagram by clicking here: <a href=\"https:\/\/www.instagram.com\/blogrechercheclinique\/\">https:\/\/www.instagram.com\/blogrechercheclinique\/<\/a><br>Do 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>If 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\n\n\n<figure class=\"wp-block-embed is-type-rich is-provider-prise-en-charge-des-contenus-embarqu-s wp-block-embed-prise-en-charge-des-contenus-embarqu-s wp-embed-aspect-16-9 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<iframe title=\"Challenge #27: Mon patient a \u00e9t\u00e9 inclus, il n&#039;avait pas les crit\u00e8res, que faire?\" width=\"1080\" height=\"608\" data-src=\"https:\/\/www.youtube.com\/embed\/A8Q_ihY6GXM?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" class=\"lazyload\" data-load-mode=\"1\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<p>Hello everyone, this is Vanessa Montanari from the clinical research blog for Pharmaspecific. Today we&rsquo;re going to look at a new topic. The patient was included when he didn&rsquo;t meet the criteria. That&rsquo;s something that can happen. Something that&rsquo;s pretty rare, but it can happen. So, what do you have to do in this situation?<\/p>\n\n\n\n<!--more-->\n\n\n\n<p>First of all, if you identify that the patient didn&rsquo;t have the criteria, the first thing to do is to go to the investigator and talk to him about it. Because the patient&rsquo;s safety is at stake here. So the doctor has to be able to find out and see if there&rsquo;s something that can be done immediately. Then you don&rsquo;t hesitate to contact the project leader and the medical monitor at the same time to inform them of this problem. You can call them by phone or send them an e-mail. However, contact them as soon as possible so that they are informed and possibly a conference call can be made if necessary. Then, what you are going to do is, once the safety period has passed, you are going to try to find solutions to prevent this from happening again in the future. A problem in the criteria may be due to a misunderstanding of the protocol by the investigator or his team. A document that has been poorly completed or a document that has been poorly done. I can give you an example. Often in the centres, the clinical study technicians prepare screening fact sheets or they may have to postpone certain criteria. If a criterion has been incorrectly reported, or there is an error in the screening form, this may have an impact on the inclusion of patients. That&rsquo;s why it&rsquo;s important that you, as a clinical research associate, can look at documents of this type, which the clinical study technician will prepare to help them avoid this type of error. What you can also do, if you haven&rsquo;t done it yet, is to prepare a small summary, which the doctor can put in his or her pocket, so that he or she can regularly check that the criteria are being followed. That visits are made on time as part of the study. So this is something that has been done for a very long time in clinical trials. But sometimes it&rsquo;s not done in some studies, and that&rsquo;s something I would say is recommended to help avoid that type of error. Don&rsquo;t forget, of course, to document all of this information, everything that has been said, the information in your report and in the follow-up letter that you&rsquo;re going to send to the investigator.<\/p>\n\n\n\n<p>There you go. That&rsquo;s what I had to tell you on the subject. If I like this program, put I like at the bottom of the video. If you want to know more about clinical research, go to the clinical research blog. The link is here. If you want to know more about Pharmaspecific, our CRO in clinical research, the website is here. You should know that Pharmaspecific has created a 100-page guide that is a feedback from our staff on clinical trials. You can get lots of tips to help you better understand clinical trials. You can download this guide at the bottom of the video. Thank you for following us.<\/p>\n\n\n\n<p>See you soon. Goodbye.<\/p>","protected":false},"excerpt":{"rendered":"<p>Bonjour \u00e0 tous, c&rsquo;est Vanessa Montanari du blog de la recherche clinique pour Pharmaspecific. Aujourd&rsquo;hui, nous allons voir un nouveau sujet. Le patient a \u00e9t\u00e9 inclus alors qu&rsquo;il n&rsquo;avait pas les crit\u00e8res. C&rsquo;est quelque chose qui peut arriver. Quelque chose qui est plut\u00f4t rare mais \u00e7a peut arriver. Donc, qu&rsquo;est-ce que vous devez faire dans cette situation ?<\/p>","protected":false},"author":4,"featured_media":14116,"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":[449],"tags":[66,41,155,8],"class_list":{"0":"post-14115","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-pratiquer-le-metier-dattache-de-recherche-clinique","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":true,"content":true,"excerpt":false}}},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Mon patient a \u00e9t\u00e9 inclus, il n\u2019avait pas les crit\u00e8res, que faire?<\/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\/patient-inclus-criteres\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Challenge #27: My patient was enrolled, he did not have the criteria, what should I do? 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What to do?","author":"Vanessa Montanari","date":"12 January 2020","format":false,"excerpt":"Aujourd'hui, nous allons voir un nouveau cas. La personne qui a sign\u00e9 le formulaire de consentement \u00e9clair\u00e9 est un interne. Donc, que faire dans ce cas-l\u00e0 ?","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":14310,"url":"https:\/\/blogdelarechercheclinique.com\/en\/dossier-medical-patient-perdu\/","url_meta":{"origin":14115,"position":1},"title":"Challenge #6 Le dossier m\u00e9dical de mon patient est perdu! 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Par contre, tous les d\u00e9tails ne se trouvent pas dans le dossier m\u00e9dical.","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":"Vid\u00e9o sur les traitement concomitants","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/traitements-concomitants.png?fit=520%2C292&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":14218,"url":"https:\/\/blogdelarechercheclinique.com\/en\/signature-consentement-eclairee\/","url_meta":{"origin":14115,"position":5},"title":"Challenge # 20: What to check when signing an informed consent form?","author":"Vanessa Montanari","date":"21 January 2020","format":false,"excerpt":"Qu'est-ce que vous devez v\u00e9rifier lorsque vous v\u00e9rifiez un consentement \u00e9clair\u00e9 pour un premier patient ? 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