{"id":6486,"date":"2020-01-21T18:00:38","date_gmt":"2020-01-21T17:00:38","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=6486"},"modified":"2025-05-26T16:16:01","modified_gmt":"2025-05-26T14:16:01","slug":"signing-informed-consent-form","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/signing-informed-consent-form\/","title":{"rendered":"Challenge #20: What to check when signing an informed consent form?"},"content":{"rendered":"<p>Challenge # 20: What to check when signing an informed consent form?<\/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 title=\"Challenge #20 : Que v\u00e9rifier lors de la signature d&#039;un consentement \u00e9clair\u00e9?\" width=\"1080\" height=\"608\" data-src=\"https:\/\/www.youtube.com\/embed\/EXlnfs_HeH8?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><\/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. What do you look for when you&rsquo;re checking <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>signing an informed consent<\/strong><\/a> for a first patient?<\/p>\n<p><!--more--><\/p>\n<p>So, first of all, you need to make sure that the investigator who signed the consent is an investigator licensed to practice medicine. You can see this on the CNOM website. This physician, he must also be on the delegation log, the task delegation form. Secondly, you must make sure that they signed either on the same date or that the investigator signed after the patient but the reverse is not possible. I refer you to my video of challenge number 1 to see why, in detail, this is important. Thirdly, you have to make sure that all the fields have been completed, that the crosses have been put where they should be in this consent. Fourth, you must ensure that a copy has been given to the patient. This information must be in the medical record. So you have to make sure that a copy has been given to the patient. This information must be in the medical record. You must also make sure that the information and personal data is true: the patient&rsquo;s first and last name, address and date of birth. You must make sure that the patient has signed his or her consent\u00a0 prior to any study procedure. For example, some investigators may be aware that the patient must be tested for hepatitis B as part of the study. Then, even before the patient signs the consent, the investigator will have the patient tested for no reason other than the reason for the study. You must make it clear to the investigator that this kind of thing should be avoided and that the patient can only start testing once he or she has <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>signed the informed consent<\/strong><\/a>. You must also make sure that the investigator of the study has reported to FDA 1572, if it is an IND study. IND studies are studies that are intended to be marketed in the United States and this form is required for this type of study. Therefore, you must make sure that the investigator has reported on this form. You must also make sure that the consent process has been done correctly. In principle, the investigator must indicate the consent process in the medical file. For example, the consent was reviewed with the patient, the consent was signed on a certain date, the patient had time to ask all the questions necessary for the study. That&rsquo;s what I wanted to tell you about informed consent.<\/p>\n<p>I hope that helped. If you want to know more about<strong> clinical research<\/strong>, you have to go to the clinical research blog, the link is here. If you want to know more about Pharmaspecific, our CRO specializing in clinical research, the link is here. You should know that Pharmasepcific has created a white paper to help you better understand clinical studies. You can download it below. It is a guide of about a hundred pages that are feedback from our teams. If you liked this video, put I like at the bottom of the video. You can give me some comments, I will answer you. I will be happy to have your opinions. Thank you for following us.<\/p>\n<p>See you soon. Bye!<\/p>","protected":false},"excerpt":{"rendered":"<p>What do you look for when you&rsquo;re checking informed consent for a first patient?<\/p>","protected":false},"author":4,"featured_media":14219,"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-6486","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>What to check when signing an informed consent form?<\/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\/signing-informed-consent-form\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Challenge #20: What to check when signing an informed consent form? 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Cette vid\u00e9o vous aidera \u00e0 mieux comprendre les diff\u00e9rentes v\u00e9rifications.","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":"check informed consent form","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/check-consent-patient.png?fit=1071%2C477&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/check-consent-patient.png?fit=1071%2C477&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/check-consent-patient.png?fit=1071%2C477&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/check-consent-patient.png?fit=1071%2C477&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/check-consent-patient.png?fit=1071%2C477&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":6323,"url":"https:\/\/blogdelarechercheclinique.com\/en\/investigator-patient-informed-consent\/","url_meta":{"origin":6486,"position":1},"title":"Challenge # 1 &#8211; Do the investigator and the patient have to sign the informed consent on the same day?","author":"Vanessa Montanari","date":"2 January 2020","format":false,"excerpt":"The question was: do the investigator and the patient have to sign the informed consent on the same date?","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":"Signature consentement \u00e9clair\u00e9","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/signature-consentement.png?fit=556%2C307&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/signature-consentement.png?fit=556%2C307&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/signature-consentement.png?fit=556%2C307&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":6426,"url":"https:\/\/blogdelarechercheclinique.com\/en\/person-signed-consent-resident-physician\/","url_meta":{"origin":6486,"position":2},"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. 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