{"id":3207,"date":"2024-06-10T11:22:34","date_gmt":"2024-06-10T15:22:34","guid":{"rendered":"https:\/\/cytel.agencyukdev.com\/perspectives\/insights-on-the-new-adam-guidelines-and-europe-interchange-2022\/"},"modified":"2024-08-22T05:45:01","modified_gmt":"2024-08-22T09:45:01","slug":"insights-on-the-new-adam-guidelines-and-europe-interchange-2022","status":"publish","type":"perspectives","link":"https:\/\/cytel.agencyukdev.com\/fr\/perspectives\/insights-on-the-new-adam-guidelines-and-europe-interchange-2022\/","title":{"rendered":"Insights on the New ADaM guidelines and Europe Interchange 2022"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p>I am excited to see you all at the CDISC Europe Interchange, April 27 \u2013 28 but unfortunately, it will be a virtual event (hopefully, for the last time). The program designed by the CDISC Europe Committee and the CDISC team looks promising as always! Silvia Faini and I (members of the committee) will lead the \u201cTech-Enabled Standards\u201d and \u201cADaM\u201d streams, respectively.<\/p>\n<p><!--more--> This year, in addition to the customary keynote presentations, updates from the regulatory agencies, which includes the EMA \u201cRaw Data Project\u201d, and other announcements, there is going to be a dedicated stream for the CDISC Core (CDISC Open Rule Engine) Project. This will be followed by a workshop on April 29, dedicated to the CDISC Open-Source Alliance (<a href=\"https:\/\/cosa.cdisc.org\/\" target=\"_blank\" rel=\"noopener\">COSA<\/a>), a CDISC initiative to support and promote open-source software projects that create tools for implementing or developing CDISC standards (see also, the current COSA Repository Directory https:\/\/cosa.cdisc.org\/).<\/p>\n<p>Several sponsors, CROs and academic organizations will share their experiences during the event. Cytel\u2019s Principal Statistical Programmer, Silvia Faini will present on \u201cADaM Traceability and Multiple Imputations\u201d where she will discuss how to achieve traceability in ADaM, particularly when you need to implement complex Multiple Imputations. You can join me at Session 6C: CDSIC Foundational \u201c20 Minutes to get you aligned with new ADaM IG (et al)\u201d, where I will introduce the most recent updates on the CDISC ADaM standard with the presentation. The focus of my presentation will be on the ADaM update:<\/p>\n<ul>\n<li>ADaM Implementation Guidance Version 1.3<\/li>\n<li>ADaM OCCDS Implementation Guidance Version 1.1<\/li>\n<li>ADaM Implementation Guidance for Medical Device Version 1.0<\/li>\n<li>ADaM Implementation Guidance for Non-Compartmental Analysis Version 1.0<\/li>\n<\/ul>\n<p>Silvia and I are looking forward to meeting you all there. Click <a href=\"https:\/\/www.cdisc.org\/events\/interchange\/2022-europe-interchange\" target=\"_blank\" rel=\"noopener\">here<\/a>, for more information on the conference.<\/p>\n<p><!--more--><\/p>\n<p>Over the years, I have written several blogs on my experience with data submission and data integration such as ISS and ISE. Click <a href=\"https:\/\/cytel.agencyukdev.com\/fr\/resource\/the-good-data-doctor-on-data-submission-and-data-integration\/\">here<\/a> to download Cytel\u2019s eBook where I share critical insights on clinical data standards submission.<\/p>\n<p>&nbsp;<\/p>","protected":false},"featured_media":3466,"parent":0,"template":"","meta":{"_acf_changed":false},"tags":[76],"by-topic":[433,414],"by-year":[72],"class_list":["post-3207","perspectives","type-perspectives","status-publish","has-post-thumbnail","hentry","tag-blog","by-topic-biometrics","by-topic-cdisc","by-year-72"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Insights on the New ADaM guidelines and Europe Interchange 2022 - Clinical Trial Software &amp; Data Analysis | Cytel | Contact Us<\/title>\n<meta name=\"description\" content=\"Join Cytel&#039;s Angelo Tinazzi at CDISC 2022 Europe Interchange at Session 6C: CDSIC Foundational.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.cytel.com\/perspectives\/insights-on-the-new-adam-guidelines-and-europe-interchange-2022\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Insights on the New ADaM guidelines and Europe Interchange 2022 - Clinical Trial Software &amp; 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