{"id":6439,"date":"2020-01-20T12:00:50","date_gmt":"2020-01-20T11:00:50","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=6439"},"modified":"2024-06-06T14:37:27","modified_gmt":"2024-06-06T12:37:27","slug":"monitoring-visit-investigator-binder","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/monitoring-visit-investigator-binder\/","title":{"rendered":"Challenge # 14 Monitoring visit: The investigator site file, What to check?"},"content":{"rendered":"<p>Challenge # 14 Monitoring visit: The investigator site file, What to check?<\/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 #14 Visite de monitoring : Le classeur investigateur, Que v\u00e9rifier?\" width=\"1080\" height=\"608\" data-src=\"https:\/\/www.youtube.com\/embed\/8Ao4-VIzjU0?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. We&rsquo;re going to talk about managing the investigator binder. How do you manage the Investigator&rsquo;s Workbook? What to check?<\/p>\n<p><!--more--><\/p>\n<p>Text transcirption :<\/p>\n<p>So, the investigator binder, as you know, every investigator has an <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>investigator site file<\/strong><\/a>. This binder is a binder containing what we call essential documents. Essential documents are the documents that are found at the level of good clinical practice. These documents should be in the binder or at the sponsor&rsquo;s site. As a Clinical Investigator, you are responsible for checking with both the sponsor and the investigator that these documents are in the right place. However, it is the responsibility of the investigator to ensure that the binder is up to date. That is, the investigator is responsible for putting a number of documents in this binder with your help. Often, clinical research associates do this and investigators are only minimally involved in this task. Clinical study technicians do not do this as well. However, it is their responsibility. Therefore, it is important that clinical study technicians are aware of the contents of their binders because in the event of an audit, the investigator will be responsible if documents are missing from the binder. As a clinical research associate, in order to be able to update this binder, it is preferable to create a list, a <a href=\"https:\/\/blogdelarechercheclinique.com\/en\/\"><strong>checklist of the investigator site file<\/strong><\/a>. This checklist is useful. It will be used in case of a change of clinical research associate. The clinical research associate will pass on this checklist to the next clinical research associate, the clinical research associate can also use the checklist from one visit to the next to ensure that the <strong>investigator&rsquo;s binder<\/strong> is up to date. From one visit to the next, the CRA will insert additional lines in the checklist to ensure that the CRA will use this list from one visit to the next to ensure that the binder is up to date. It is also important to specify in the visit report that such essential documents are missing from the binder and will need to be brought back at the next visit. The clinical research associate may also send the documents with the follow-up letter that he or she sends to the investigator after each monitoring visit. However, it is always preferable to bring the documents back yourself to avoid that the documents are not put away, that they are left by the <strong>investigator with the binder<\/strong> without necessarily being put away.<\/p>\n<p>I hope this video has helped you to improve your monitoring. If you liked this program, please put I like at the bottom of the video. The Clinical Research Blog is a blog where you can get a lot of information about clinical research, so don&rsquo;t hesitate to visit it. The address is here. If you want to know more about Pharmaspecific, our <a href=\"https:\/\/www.pharmaspecific.com\"><strong>CRO specialized in clinical research<\/strong><\/a>, you can learn more by going to this address. I also wanted to tell you that Pharmaspecific has written a guide to help you better understand clinical trials as a CRO or as a project manager. So I encourage you to download this guide. It&rsquo;s at the bottom of the video there. Thank you for following us and see you soon. Bye!<\/p>","protected":false},"excerpt":{"rendered":"<p>We&rsquo;re going to talk about managing the investigator binder. How do you manage the Investigator&rsquo;s Workbook? What to check?<\/p>","protected":false},"author":4,"featured_media":14243,"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":[390],"tags":[66,41,155,8],"class_list":{"0":"post-6439","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-jeux-evenements","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>Monitoring visit: The investigator site file, What to check?<\/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\/monitoring-visit-investigator-binder\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Challenge # 14 Monitoring visit: The investigator site file, What to check? -\" \/>\n<meta property=\"og:url\" content=\"https:\/\/blogdelarechercheclinique.com\/en\/monitoring-visit-investigator-binder\/\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/blogdelarechercheclinique\" \/>\n<meta property=\"article:published_time\" content=\"2020-01-20T11:00:50+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-06-06T12:37:27+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/classeur-investigateur.png?fit=827%2C465&ssl=1\" \/>\n\t<meta property=\"og:image:width\" content=\"827\" \/>\n\t<meta property=\"og:image:height\" content=\"465\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Vanessa Montanari\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Vanessa Montanari\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/blogdelarechercheclinique.com\/monitoring-visit-investigator-binder\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/monitoring-visit-investigator-binder\/\"},\"author\":{\"name\":\"Vanessa Montanari\",\"@id\":\"https:\/\/blogdelarechercheclinique.com\/#\/schema\/person\/13ee3f7a1251afe7e98918a482685938\"},\"headline\":\"Challenge # 14 Monitoring visit: The investigator site file, What to check?\",\"datePublished\":\"2020-01-20T11:00:50+00:00\",\"dateModified\":\"2024-06-06T12:37:27+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/monitoring-visit-investigator-binder\/\"},\"wordCount\":706,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/monitoring-visit-investigator-binder\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/classeur-investigateur.png?fit=827%2C465&ssl=1\",\"keywords\":[\"Attach\u00e9 de recherche clinique\",\"CRO\",\"Etude clinique\",\"recherche clinique\"],\"articleSection\":[\"Jeux - \u00e9v\u00e8nements\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/blogdelarechercheclinique.com\/monitoring-visit-investigator-binder\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/blogdelarechercheclinique.com\/monitoring-visit-investigator-binder\/\",\"url\":\"https:\/\/blogdelarechercheclinique.com\/monitoring-visit-investigator-binder\/\",\"name\":\"Monitoring visit: The investigator site file, What to check?\",\"isPartOf\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/monitoring-visit-investigator-binder\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/blogdelarechercheclinique.com\/monitoring-visit-investigator-binder\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/classeur-investigateur.png?fit=827%2C465&ssl=1\",\"datePublished\":\"2020-01-20T11:00:50+00:00\",\"dateModified\":\"2024-06-06T12:37:27+00:00\",\"description\":\"Every investigator has an investigator . 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3 The medical file is in electronic version, What should I pay attention to?","author":"Vanessa Montanari","date":"4 January 2020","format":false,"excerpt":"So either having a computerized record is not a problem but it all depends on what type of computerized record you have.","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":"Dossier m\u00e9dical \u00e9lectronique","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/dossier-medical-electronique.png?fit=523%2C291&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":6327,"url":"https:\/\/blogdelarechercheclinique.com\/en\/adverse-events-crf\/","url_meta":{"origin":6439,"position":1},"title":"Challenge # 2 My investigator refuses to put certain adverse events in the CRF","author":"Vanessa Montanari","date":"3 January 2020","format":false,"excerpt":"It happens that the investigator does not want to add certain adverse events that you found in the medical record, in the the CRF then what should you do in this case ?","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":"Ev\u00e8nements ind\u00e9sirables dans le CRF","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/evenements-indesirables-CRF.png?fit=627%2C348&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/evenements-indesirables-CRF.png?fit=627%2C348&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/evenements-indesirables-CRF.png?fit=627%2C348&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":6393,"url":"https:\/\/blogdelarechercheclinique.com\/en\/patient-medical-record-lost\/","url_meta":{"origin":6439,"position":2},"title":"Challenge #6 My patient&rsquo;s medical record is lost! What can I do?","author":"Vanessa Montanari","date":"7 January 2020","format":false,"excerpt":"Today we're going to be looking at a new case. The patient's medical records are lost. What do we do now?","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":"Dossier m\u00e9dical perdu","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/dossier-medical-perdu.png?fit=553%2C311&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/dossier-medical-perdu.png?fit=553%2C311&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/dossier-medical-perdu.png?fit=553%2C311&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":6456,"url":"https:\/\/blogdelarechercheclinique.com\/en\/france-ask-diplomas-investigators\/","url_meta":{"origin":6439,"position":3},"title":"Challenge #18: In France, should you ask for the diplomas of the investigators?","author":"Vanessa Montanari","date":"20 January 2020","format":false,"excerpt":"Today we're going to look at a new topic. The question we're going to ask is, in France, can we ask for investigators' diplomas?","rel":"","context":"In &quot;Clinical Research Job Interviews&quot;","block_context":{"text":"Clinical Research Job Interviews","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/clinical-research-job-interviews\/"},"img":{"alt_text":"Dipl\u00f4me investigateur","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/diplome-investigateur.png?fit=1070%2C596&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/diplome-investigateur.png?fit=1070%2C596&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/diplome-investigateur.png?fit=1070%2C596&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/diplome-investigateur.png?fit=1070%2C596&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/diplome-investigateur.png?fit=1070%2C596&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":6408,"url":"https:\/\/blogdelarechercheclinique.com\/en\/replacing-clinical-research-associate\/","url_meta":{"origin":6439,"position":4},"title":"Challenge # 9 I am replacing a clinical research associate permanently, What to check?","author":"Vanessa Montanari","date":"10 January 2020","format":false,"excerpt":"Today we're going to talk about a new topic: you are an ARC in a company and you've been asked to work on the new study because one of the other company employees is leaving. What can you do? That is, what to check? How do you prepare for this\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":"Remplacer un ARC","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/remplacer-arc.png?fit=548%2C311&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/remplacer-arc.png?fit=548%2C311&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/remplacer-arc.png?fit=548%2C311&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":6404,"url":"https:\/\/blogdelarechercheclinique.com\/en\/serious-adverse-events\/","url_meta":{"origin":6439,"position":5},"title":"Challenge # 8 A serious adverse events during the weekend. the declaration did not take place within 24 hours. 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