{"id":77889,"date":"2024-06-18T01:22:35","date_gmt":"2024-06-17T23:22:35","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=resources&#038;p=77889"},"modified":"2025-12-09T10:08:44","modified_gmt":"2025-12-09T09:08:44","slug":"faster-training-faster-trials-guide-for-site-training","status":"publish","type":"resources","link":"https:\/\/www.veeva.com\/eu\/resources\/faster-training-faster-trials-guide-for-site-training\/","title":{"rendered":"Faster Training, Faster Trials: Guide for Site Training"},"content":{"rendered":"<p>\nStudy training is a high-stakes process. Missing study training documentation can lead to <a href=\"\/eu\/blog\/bringing-agility-and-scalability-to-study-training\/\">critical<br \/>\ninspection findings<\/a>, resulting in commercialization delays and lost revenue. The potential cost of<br \/>\nreceiving an FDA Form 483 can easily top <a href=\"https:\/\/redica.com\/fsma-pharma-medical-devices-the-ultimate-guide-to-form-fda-483s\/\" target=\"blank\" rel=\"noopener noreferrer\">$250,000<\/a>.\n<\/p>\n<p>\nRecent FDA <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/compliance-actions-and-activities\/warning-letters\" target=\"blank\" rel=\"noopener noreferrer\">warning letters<\/a> reveal various study training-related challenges at sites, including: <\/p>\n<ul>\n<li><strong>Role training<\/strong><\/br><br \/>\nThe investigator and sub-investigators needed<br \/>\nmore training on study roles and compliance<br \/>\nwith the delegated tasks.\n<\/li>\n<li><strong>SOP training<\/strong><\/br><br \/>\nThe investigator and other clinical research<br \/>\npersonnel needed training on applicable SOPs.\n<\/li>\n<li><strong>Process training<\/strong><\/br><br \/>\nThe investigator failed to ensure that study<br \/>\nparticipants met protocol-required inclusion<br \/>\ncriteria and needed to facilitate training on<br \/>\nadditional SOPs and internal processes.\n<\/li>\n<li><strong>Documentation training<\/strong><\/br><br \/>\nSite staff needed training on proper<br \/>\ndocumentation according to Attributable,<br \/>\nLegible, Contemporaneous, Original, Accurate,<br \/>\nand Complete (ALCOAC) guidelines.\n<\/li>\n<\/ul>\n<p>\nHowever, sponsors and CROs can implement processes to mitigate these risks and improve the<br \/>\nstudy training they deliver to sites. This guide will assess the regulatory landscape and share tips<br \/>\nto streamline and improve site training.\n<\/p>\n<h2>Reduce SIV training time and increase efficiency<\/h2>\n<p>\nIn addition to its regulatory implications, study training represents a large hidden cost during<br \/>\nclinical trials.\n<\/p>\n<p>\nFor the average Phase 2 study with 40 sites, site initiation visits (SIVs) cost upward of $140,000 \u2014<br \/>\nassuming $3,500 per SIV. It costs an additional $900 on average to train each internal study<br \/>\nteam member. This means that study training costs more than $200,000 per study, assuming<br \/>\nthat everyone completes training once and correctly. With retraining, study training costs<br \/>\n$350,000 per Phase 2 study.<sup>1<\/sup>\n<\/p>\n<p>\nIn particular, improving SIVs can help sponsors and CROs start on the right foot with sites.<br \/>\nCompanies can reduce study training costs by administering study training, including protocol<br \/>\ntraining, ahead of the SIV via a purpose-built learning management system (LMS). Picture a scenario<br \/>\nin which site staff are gathered in a room, reviewing a PowerPoint presentation with screenshots<br \/>\nof each section of the protocol. Then imagine replacing that with an interactive package of online<br \/>\nmaterials, including a video overview of the compound and a quiz on the protocol.\n<\/p>\n<h3>Improving SIVs with a purpose-built LMS<\/h3>\n<p><img decoding=\"async\" style=\"border-radius: 25px;\" class=\"img-responsive\" width=900 height=700 alt=\"\" src=\"\/eu\/wp-content\/uploads\/2025\/06\/Quality-Site-Training-PDF-.png\"><br \/>\n<\/p>\n<p><at-a-glance class=\"gray\"><\/p>\n<h3>$ 70.000 savings on each Phase II study (50% savings)<\/h3>\n<p><\/at-a-glance><\/p>\n<p>\nThe latter is more effective and efficient, enabling<br \/>\nclinical research associates (CRAs) to spend less<br \/>\ntime on-site administering training. Instead, they<br \/>\ncan focus on higher-value activities such as:<\/p>\n<ul>\n<li>Answering PI questions on the protocol<br \/>\nor dosing<\/li>\n<li>Reviewing enrollment criteria<\/li>\n<li>Building relationships with site staff<\/li>\n<\/ul>\n<p>\nWithin the purpose-built LMS, CRAs can also<br \/>\neasily record proof of completion in a compliant<br \/>\nmanner. This saves time during the SIV that would<br \/>\notherwise be spent gathering paper signatures.<br \/>\nAn LMS also makes it easier to account for<br \/>\ntraining of site staff who miss the SIV.\n<\/p>\n<p>\nThese incremental changes add up. If the sponsor<br \/>\nor CRO can shorten the SIV from two days to one<br \/>\nwith this approach, they can cut the costs of site<br \/>\ntraining in half.\n<\/p>\n<h2>Support sites throughout the study<\/h2>\n<p>\nSponsors and CROs can similarly improve site study training throughout the course<br \/>\nof a trial, better engaging sites in conduct and closeout.\n<\/p>\n<p>\nOne large biopharma currently uses non-purpose-built systems to deliver training<br \/>\nto sponsor and site users. The biopharma\u2019s clinical systems implementation<br \/>\ndirector notes that the systems frustrate users: \u201cThe systems weren\u2019t originally<br \/>\nbuilt to support protocol training, and users find the systems to be cumbersome<br \/>\nand time-consuming.\u201d\n<\/p>\n<p>\nThey are looking to replace these systems with a purpose-built solution to improve<br \/>\nstudy training, curriculum structure, and user satisfaction.\n<\/p>\n<h2>Increase study training effectiveness<br \/>\nwith microlearning<\/h2>\n<p>\nSponsors and CROs can also increase the effectiveness of study training by implementing<br \/>\nmicrolearning methods.\n<\/p>\n<p>\nMicrolearning improves learner interaction and knowledge retention with shorter, focused, more<br \/>\ncompelling content delivered through channels like video. It compliments macrolearning, which<br \/>\ntypically deals with larger, more complex skill areas.\n<\/p>\n<p>\nTwo key characteristics of microlearning are brevity and specificity. A microlearning experience:<\/p>\n<ul>\n<li>Has a single, well-defined learning objective<\/li>\n<li>Focuses on a discrete task, skill, or topic<\/li>\n<li>Typically takes less than 15 minutes for a learner to complete<\/li>\n<\/ul>\n<p>\nFor example, this could include a two-minute video overview of a study\u2019s compound. The benefits<br \/>\nare clear: Studies show that microlearning results in 85% higher sustained knowledge, especially<br \/>\nwhen used after long-form training.\n<\/p>\n<p><img decoding=\"async\" style=\"border-radius: 25px;\" class=\"img-responsive\" width=800 height=600 alt=\"\" src=\"\/wp-content\/uploads\/2024\/12\/Quality-PDF-Img-3.png\"><\/p>\n<p>\nHere are some practical ways to apply microlearning techniques to more effectively train<br \/>\nsite staff:\n<\/p>\n<p><img decoding=\"async\" style=\"border-radius: 25px;\" class=\"img-responsive\" width=800 height=600 alt=\"\" src=\"\/wp-content\/uploads\/2024\/12\/Quality-PDF-Img-4.png\"><\/p>\n<p>\nBefore and after the SIV, sponsors and CROs can supplement on-site time with microlearning<br \/>\nopportunities. This ultimately improves compliance and reduces the risk of protocol deviations,<br \/>\nwhich leads to better patient safety and less retraining.\n<\/p>\n<p>\nMore effective training will also improve working relationships with sites and enable sponsors<br \/>\nto become a site\u2019s sponsor-of-choice.\n<\/p>\n<p>Learn how you can increase your organization&#8217;s study training efficiency and effectiveness with <a href=\"\/eu\/resources\/veeva-study-training-overview-demo\/\">Veeva Study Training<\/a>.<\/p>\n<p><footnotes><\/p>\n<hr>\n<p>   <sup>1<\/sup>Internal analysis, Veeva Systems, June 2024.<br \/>\n<\/footnotes><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Get actionable tips to streamline site training, mitigate compliance risk, and improve study training efficiency.<\/p>\n","protected":false},"featured_media":77890,"parent":0,"template":"","class_list":["post-77889","resources","type-resources","status-publish","has-post-thumbnail","hentry","resource-area-20-clinical-operations","resource-product-20-study-training","resource-type-white-papers"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/77889"}],"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\/77889\/revisions"}],"predecessor-version":[{"id":84115,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/resources\/77889\/revisions\/84115"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/77890"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=77889"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}