{"id":82707,"date":"2025-03-19T02:00:38","date_gmt":"2025-03-19T01:00:38","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=resources&#038;p=82707"},"modified":"2026-01-27T15:00:22","modified_gmt":"2026-01-27T14:00:22","slug":"safety-edc-connection-features-brief","status":"publish","type":"resources","link":"https:\/\/www.veeva.com\/eu\/resources\/safety-edc-connection-features-brief\/","title":{"rendered":"Safety-EDC Connection Features Brief"},"content":{"rendered":"<style>\n.veeva-2024 .fa-ul li p {\nmargin-top:5px;\n}\n.veeva-2024 .content-block .fa-check-circle {\ncolor: #f7981d;\nfont-weight: 400;\nfont-size:20px;\n}\n@media (min-width:768px) {\n.veeva-2024 .hero-centered {\npadding: 100px 0;\n}\n}\n@media (min-width:992px) {\n.veeva-2024 .content-block {\nmargin-top: 6rem;\n}\n}\n.veeva-2024 .content-block__sidebar {\ndisplay:none;\n}\n\/* to remove the mobile dropdown *\/\n.veeva-2024 .form-dropdown {\ndisplay: none;\n}\n<\/style>\n<h2>Streamline Clinical Serious Adverse Event (SAE) Reporting and Management<\/h2>\n<p>Automatically exchange comprehensive information on reported events, including serious adverse events (SAEs), and streamline reconciliation between data management and pharmacovigilance teams with the Safety-EDC Connection. There is flexibility to choose and transfer information from over 200 casebook and custom data fields (100% more than E2B), including relevant subject data. Easily sharing applicable information reduces queries for clinical sites and enables pharmacovigilance teams to more rapidly process cases and improve quality of safety outputs.<\/p>\n<p>Clinical and data teams have visibility into receipt of SAEs and case ID if an adverse event is promoted to a case in ³Ô¹Ï±¬ÁÏ Safety. If a site(s) makes a change to a SAE, new data is automatically sent to ³Ô¹Ï±¬ÁÏ Safety and linked as a follow-up. Follow-ups may also be flagged as \u2018significant\u2019 to ensure timely processing for inflight cases. Linking SAEs and case follow-ups back to clinical source data, reduces risk of inconsistent data and case processing review time as well as streamlines reconciliation processes.<\/p>\n<h2>Business Benefits<\/h2>\n<p>³Ô¹Ï±¬ÁÏ\u2019s purpose-built Safety-EDC Connection automates data sharing between ³Ô¹Ï±¬ÁÏ EDC and ³Ô¹Ï±¬ÁÏ Safety.<\/p>\n<h3>Safety Team<\/h3>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Automate intake of comprehensive data:<\/strong><\/p>\n<p>Transfer 200+ clinical subject reportable event data fields <\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n  <strong>Accelerate case processing:<\/strong><\/p>\n<p>View and add relevant subject data <\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Improve safety outputs:<\/strong><\/p>\n<p>View the SAE with totality of subject information Clinical and Data Teams<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Streamline reconciliation:<\/strong><\/p>\n<p>SAE, subject data, and follow-ups are linked back to clinical source<\/p>\n<\/li>\n<\/ul>\n<h3>Clinical and Data Teams<\/h3>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Significantly reduce manual reconciliation:<\/strong><\/p>\n<p>Data consistency between EDC and safety applications with automated data flow<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n  <strong>Reduce site burden:<\/strong><\/p>\n<p>PV teams independently access and add relevant subject data, reducing queries for sites and clinical teams<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"far fa-check-circle\"><\/i><\/span><br \/>\n   <strong>Efficient communication:<\/strong><\/p>\n<p>Visibility into SAE receipt and safety case ID<\/p>\n<\/li>\n<\/ul>\n<p>How it Works<\/p>\n<p>When a clinical site enters a SAE in ³Ô¹Ï±¬ÁÏ EDC, the Safety-EDC connection automatically creates an inbox item in ³Ô¹Ï±¬ÁÏ Safety and transfers relevant subject data. A case processor reviews the new safety inbox item, and if it meets the criteria, promotes the SAE to an initial case and shares the ³Ô¹Ï±¬ÁÏ Safety Case ID with ³Ô¹Ï±¬ÁÏ EDC. During case processing in ³Ô¹Ï±¬ÁÏ Safety, if medical reviewers need more data, they can view and include additional subject information in ³Ô¹Ï±¬ÁÏ EDC such as medical and drug history, test results, and other adverse events. If a site user later updates the SAE in ³Ô¹Ï±¬ÁÏ EDC, the Safety-EDC connection automatically creates a new follow-up inbox item, links it to the safety case, and may flag as significant based on pre-defined criteria. The case processor can review and optionally merge the follow-up data with the existing case.<\/p>\n<p>Synchronization of data between ³Ô¹Ï±¬ÁÏ EDC and ³Ô¹Ï±¬ÁÏ Safety is managed and maintained with mapped data fields. Organizations can easily add, modify, or disable default fields, simplifying setup and configuration.<\/p>\n<p><img decoding=\"async\" style=\"border-radius: 25px;\" class=\"img-responsive mw-800\" alt=\"\" src=\"\/wp-content\/uploads\/2025\/08\/Safety-EDC-Features-Brief.png\"><\/p>\n<p>Join the coffee break demo to see a live <a href=\"\/eu\/products\/vault-platform\/veeva-connections\/\">Safety-EDC Connection demo<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Automate clinical serious adverse events (SAE) reporting to safety, increase quality of PV data, and reduce reconciliation with Safety-EDC Connection.<\/p>\n","protected":false},"featured_media":82708,"parent":0,"template":"","class_list":["post-82707","resources","type-resources","status-publish","has-post-thumbnail","hentry","resource-area-20-clinical-data-management","resource-area-20-development-cloud-a","resource-area-20-safety","resource-area-20-vault-platform-area","resource-product-20-development-cloud","resource-product-20-edc","resource-product-20-safety2","resource-product-20-vault-platform","resource-type-product-briefs"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/82707"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/resources"}],"version-history":[{"count":1,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/82707\/revisions"}],"predecessor-version":[{"id":83070,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/82707\/revisions\/83070"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/82708"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=82707"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}