{"id":583,"date":"2015-01-27T20:30:48","date_gmt":"2015-01-27T19:30:48","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=583"},"modified":"2025-05-21T10:54:07","modified_gmt":"2025-05-21T08:54:07","slug":"visite-de-fermeture","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/visite-de-fermeture\/","title":{"rendered":"Keys for a successful closure visit!"},"content":{"rendered":"<h1>Keys for\u00a0a successful closure visit!<\/h1>\n<p>You are CRA and you are about to close a center? Know that a closing visit is differently prepared from a monitoring visit. So here are some tips to guide you to a successful closing visit! (Tested and approved:) )<\/p>\n<p>\b<\/p>\n<div id=\"attachment_131\" style=\"width: 209px\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/wp-content\/uploads\/2014\/09\/0010765716J-565x849.jpg\"><img data-recalc-dims=\"1\" decoding=\"async\" aria-describedby=\"caption-attachment-131\" class=\"size-medium wp-image-131 lazyload\" data-src=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/wp-content\/uploads\/2014\/09\/0010765716J-565x849-199x300.jpg?resize=199%2C300\" alt=\"Every good thing has an end. See you Doctor ! \" width=\"199\" height=\"300\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 199px; --smush-placeholder-aspect-ratio: 199\/300;\" \/><\/a><p id=\"caption-attachment-131\" class=\"wp-caption-text\">Every good thing has an end. See you Doctor !<\/p><\/div>\n<p><!--more--><\/p>\n<h2>1. Well prepare your visit<\/h2>\n<p>Well preparing a closing visit is essential. This will save you time on site, both for you and your investigator team.<\/p>\n<ul>\n<li>Make sure you have a\u00a0complete checklist of the investigator and \/ or pharmacy workbook. Update it regularly during your monitoring visits and collect\u00a0the documents progressively. Do not underestimate this task, because depending on the study complexity, a workbook can contain\u00a0several volumes!<\/li>\n<li>Print the missing documents or those to be signed by the team, bring them back\u00a0on site during your visit. Similarly for blank forms, just in case (accounting form for the study products, for example).<\/li>\n<li>You can also anticipate the lack of a document such\u00a0as the lack of a training certificate of a team member who left the hospital, by\u00a0preparing a note to file, ready to be signed by the investigator.<\/li>\n<\/ul>\n<ul>\n<li>By means of previous monitoring reports and follow-up letters, and\u00a0also with your updated monitoring tables, create\u00a0a calendar listing the pending\u00a0issues (the queries), in order to remind\u00a0you to solve them with the investigator team.<\/li>\n<\/ul>\n<ul>\n<li>To be more effective, inform the investigator in the confirmation letter that you will send him in advance\u00a0(the week before the visit, by email) the agenda of the visit, the persons that need to be present and the possible\u00a0latest required documents (thanks to your checklist! CV, documents to be signed, etc&#8230;).<\/li>\n<\/ul>\n<ul>\n<li>To avoid any surprise, the day before your visit confirm that you are coming\u00a0to the center, with\u00a0a simple phone call or email. You must be sure that the principal investigator will be\u00a0there the day of your visit. If it is not the case, contact your project manager the soonest possible to react accordingly\u00a0(shift the date of the visit or still visit the\u00a0site).<\/li>\n<\/ul>\n<ul>\n<li>Also mind to ask the center how they wish to save\u00a0the study documents. Do they need archive boxes? Or do they want to save\u00a0the documents in the files originally supplied? If they cannot get them, bring some boxes. You can, for example, note on the archives boxes, to be easily found during audit or inspection:<\/li>\n<li>The name of the study<\/li>\n<li>A statement as \u00ab\u00a0Do not destroy before XXXX\u00a0\u00bb (end of filing date)<\/li>\n<li>The investigator and laboratory name<\/li>\n<\/ul>\n<h2>2. During the visit<\/h2>\n<p><em>At the pharmacy:<\/em><\/p>\n<p>Make the final accounting treatment of the study and prepare their return or destruction. In case of on site destruction, retrieve the certificates of destruction.<\/p>\n<p>Check and update the workbook. inform\u00a0the pharmacy team of the place and the duration of \u00a0study documents conservation. Sometimes the pharmacy keeps\u00a0the pharmacy workbook and does not want to let it with the investigator workbook.<\/p>\n<p><em>In the clinical service:<\/em><\/p>\n<p>In order to remember everything, make sure to follow the agenda that you have set for yourself: check and validate the latest data and \/ or queries, then finalize the investigator workbook using your updated checklist. Destroy the extra blank documents (unless the promoter ordered the opposite) and retrieve copies \/ original of documents for archiving in the promoter.<\/p>\n<p>Well arrange informed consents in the investigator workbook so that they are all centralized in one place and easy to find when needed. Some investigators tend to leave them in the medical patients records.<\/p>\n<p>In case\u00a0the promoter requests, retrieve eventually loaned equipment to lead\u00a0the research.<\/p>\n<p>Make sure to remind the investigator his various obligations during the closure : archiving time period for investigator workbook, audits or inspections, articles publication &#8230;<\/p>\n<p>Find out about the exact study documents and patient records storage location : on site, or outside of the hospital? Well file this information in your closure report; it can be used in a few years in case of audit or inspection.<\/p>\n<h2>3. After the visit<\/h2>\n<p>Write the closure report and transmit it to your project manager right away as long as you still have ideas in mind!<\/p>\n<p>Then prepare the closure letter, both for the investigator and for pharmacy, reminding the site the investigator obligations mentioned above: his responsibility in terms of\u00a0archiving (<a href=\"http:\/\/www.legifrance.gouv.fr\/affichCodeArticle.do?cidTexte=LEGITEXT000006072665&amp;idArticle=LEGIARTI000025788704&amp;dateTexte=20130820\" target=\"_blank\" rel=\"noopener noreferrer\">Article E1123-61 of CSP<\/a>) the investigator workbook and \/ or pharmacy and its duration (depending on the type of products studied, see the <a href=\"http:\/\/www.legifrance.gouv.fr\/affichTexte.do;jsessionid=AD2950CA9399437F0597DE04F43A8390.tpdjo06v_2?cidTexte=JORFTEXT000000641558&amp;dateTexte=20150121\" target=\"_blank\" rel=\"noopener noreferrer\">Decree of 8 November 2006<\/a>), the scope of audit or inspection of the competent French authorities and \/ or of another countries in case of international study, conditions of scientific articles publications&#8230;<\/p>\n<p>These are what to help you preparing your closing visit. Good luck!<\/p>\n<p>Do you have a group, a page, a profile or an additional advice to share? Leave it in the comments.<\/p>\n<p>If you liked this article, I invite you to click on \u00ab\u00a0I like\u00a0\u00bb or share with your CRA colleagues and friends and project Manager<\/p>\n<p>Also, visit Pharmaspecific website : \u00a0<a href=\"http:\/\/www.pharmaspecific.fr\" target=\"_blank\" rel=\"noopener noreferrer\">http:\/\/www.pharmaspecific.fr<\/a>\u00a0and discover our activities.<\/p>\n<p>You can visit the Facebook page of \u00ab\u00a0blog de la recherche clinique\u00a0\u00bb\u00a0and the\u00a0\u00ab\u00a0Pharmaspecific\u00a0\u00bb\u00a0and click on \u00ab\u00a0I like\u00a0\u00bb to support us.<\/p>\n<p>See\u00a0\u00ab\u00a0<a href=\"https:\/\/www.linkedin.com\/company\/pharmaspecific\/\" target=\"_blank\" rel=\"noopener noreferrer\">Pharmaspecific Linkedin<\/a>\u00a0\u00bb\u00a0and\u00a0\u00ab\u00a0<a href=\"https:\/\/www.linkedin.com\/in\/vanessamontanari\/\" target=\"_blank\" rel=\"noopener noreferrer\">Vanessa Montanari Linkedin<\/a>\u00a0\u00bb\u00a0for more relevant news on clinical researches.<\/p>\n<p>See us as well on\u00a0<a href=\"http:\/\/fr.viadeo.com\/fr\/company\/pharmaspecific\" target=\"_blank\" rel=\"noopener noreferrer\">Pharmaspecific Viadeo<\/a>\u00a0and\u00a0<a href=\"https:\/\/viadeo.journaldunet.com\/p\/vanessa-montanari-820852\" target=\"_blank\" rel=\"noopener noreferrer\">Vanessa Viadeo<\/a><\/p>\n<p>You can also subscribe to the blog&rsquo;s newsletter we will keep you posted once a new article is published.<\/p>","protected":false},"excerpt":{"rendered":"<p>Article r\u00e9dig\u00e9 par la Soci\u00e9t\u00e9 Pharmaspecific, sp\u00e9cialiste en recherche clinique Les clefs d\u2019une visite de fermeture r\u00e9ussie !&#8230;<\/p>","protected":false},"author":4,"featured_media":0,"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":[454],"tags":[16,66,110,128,129,140],"class_list":{"0":"post-583","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-strategie-devolution-pour-atteindre-vos-objectifs","7":"tag-arc","8":"tag-attache-de-recherche-clinique","9":"tag-emploi-attache-de-recherche-clinique","10":"tag-formation-attache-de-recherche-clinique","11":"tag-salaire-attache-de-recherche-clinique","12":"tag-visite-de-fermeture"},"translation":{"provider":"WPGlobus","version":"3.0.2","language":"en","enabled_languages":["fr","en"],"languages":{"fr":{"title":true,"content":true,"excerpt":false},"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>The keys to a successful closure visit!<\/title>\n<meta name=\"description\" content=\"You are CRA and you are about to close a center? 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