{"id":50192,"date":"2020-06-12T21:10:24","date_gmt":"2020-06-12T19:10:24","guid":{"rendered":"http:\/\/www.veeva.com\/eu\/?post_type=resources&#038;p=50192"},"modified":"2025-11-28T13:16:02","modified_gmt":"2025-11-28T12:16:02","slug":"veeva-ctms-study-oversight-checklist","status":"publish","type":"resources","link":"https:\/\/www.veeva.com\/eu\/resources\/veeva-ctms-study-oversight-checklist\/","title":{"rendered":"Veeva CTMS Study Oversight Checklist"},"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}<\/p>\n<p>.veeva-2024 .content-block__content .stat-box {\nbackground: #eef1f5;\ndisplay: inline-block;\npadding: 10px 30px;\nborder-radius: 16px;\nfont-size: 18px;\nmargin: 5px 5px 20px 5px;\nfont-weight: 500;\n}\n.veeva-2024 .content-block__content .stat-box span {\ncolor:#f5670e;\nfont-weight:600;\n}\n\/* to remove the mobile dropdown *\/\n.veeva-2024 .form-dropdown {\ndisplay: none;\n}\n  .fa-ul {\nlist-style-type: none;\nmargin-left: 28px;\npadding-left: 0;\n}\n  .fas.fa-check-square {\nfont-weight: normal;\nfont-size: 24px;\n}\n.resources-content at-a-glance {<\/p>\n<p>padding: 20px 20px 15px 20px;<\/p>\n<p>}\n.resources-content ul ul {\nmargin-bottom:15px;\n}\n<\/style>\n<p><img decoding=\"async\" class=\"img-right d-none d-lg-block\" alt=\"\" src=\"\/wp-content\/uploads\/2025\/07\/study-oversight-checklist-figure-1.png\"><\/p>\n<h2>Study Oversight Checklist<\/h2>\n<p><img decoding=\"async\" class=\"img-right d-block d-lg-none\" alt=\"\" src=\"\/wp-content\/uploads\/2025\/07\/study-oversight-checklist-figure-1.png\"><\/p>\n<p>Sponsors have a regulatory responsibility to ensure trial quality, integrity, patient safety, and internal sponsor\/ partner adherence to standard operating procedures (SOPs) in outsourced clinical trials. Sponsors must also be able to demonstrate they maintained oversight throughout the course of the study to inspectors.<\/p>\n<p>See the checklist below for what you should look for in a CTMS application for study oversight to help ensure compliance with ICH E6(R2) guidelines.<\/p>\n<h3>Full lifecycle issue management<\/h3>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span>\n<p>Capture, track, and resolve protocol deviations<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span>\n<p>Maintain records of all actions and follow-up items<\/p>\n<\/li>\n<\/ul>\n<h3>Monitoring oversight<\/h3>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span>\n<p>Track monitoring visit report (MVR) reviews and approvals<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span>\n<p>Maintain workflow history<\/p>\n<\/li>\n<\/ul>\n<h3>Ability to receive data from systems<\/h3>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span>\n<p>Easily integrate CRO and sponsor CTMS and other clinical systems to view data holistically<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span>\n<p>Collaborate more effectively with CROs for a better view of trial performance<\/p>\n<\/li>\n<\/ul>\n<h3>Built-in oversight reporting and metrics<\/h3>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span>\n<p>Track KPIs and KRIs (protocol deviations by site\/study, MVR quality findings, SAEs by site, missing ICFs, etc.)<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span>\n<p>View data at summary and detailed levels<\/p>\n<\/li>\n<\/ul>\n<h3>Documentation repository<\/h3>\n<ul class=\"fa-ul\">\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span>\n<p>Store site communication logs and documents for key items such as escalation procedures<\/p>\n<\/li>\n<li><span class=\"fa-li\"><i class=\"fas fa-check-square\"><\/i><\/span>\n<p>Show proof of sponsor and CRO acceptance and approvals<\/p>\n<\/li>\n<\/ul>\n<p><a href=\"\/CTMS-oversight\/\" class=\"after-arrow-orange\">Learn more about Veeva CTMS for study oversight<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>See the checklist for what you should look for in a CTMS application for study oversight.<\/p>\n","protected":false},"featured_media":55247,"parent":0,"template":"","class_list":["post-50192","resources","type-resources","status-publish","has-post-thumbnail","hentry","resource-area-20-clinical-operations","resource-product-20-ctms","resource-type-product-briefs"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/50192"}],"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":2,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/50192\/revisions"}],"predecessor-version":[{"id":75401,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/50192\/revisions\/75401"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/55247"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=50192"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}