[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-665400-105":3,"detail-sidebar-cat-0-en-105":80,"doc-detail-665400-en":130},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":73,"head_meta":75,"extra_data":77,"updated_unix":79},105,"en","clinical-trials-and-root-cause-analysis","Clinical-Trials-and-Root-Cause-Analysis","","Training and case-study material describing how root cause analysis methods apply to pharmaceutical and healthcare contexts. It outlines key concepts, definitions, and methodologies, then presents a discovery process connecting safety monitoring, pre-approval inspection, regulatory submission, and clinical trials workflows. A detailed incident narrative follows the lifecycle of hydraulic fluid used in cleaning instruments, explaining detection, patient impact, and the reasoning steps that identify the hydraulic fluid’s role and effects over time.",{"@graph":14,"@context":72},[15,34,55],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/research-report/","Research & Report",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/clinical-trials-and-root-cause-analysis/665400/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/clinical-trials-and-root-cause-analysis/665400.png","ImageObject",300,407,{"name":42,"@type":43},"I feel Different","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-30","2026-10-29",true,{"@type":52,"interactionType":53,"userInteractionCount":22},"InteractionCounter",{"@type":54},"ViewAction",{"@type":56,"mainEntity":57},"FAQPage",[58,64,68],{"name":59,"@type":60,"acceptedAnswer":61},"What incident is used in the case study to demonstrate root cause analysis?","Question",{"text":62,"@type":63},"The case study follows an actual event involving an elevator repair that led to hydraulic fluid being used to wash surgical instruments before sterilization, affecting patients.","Answer",{"name":65,"@type":60,"acceptedAnswer":66},"What was the root problem connected to the hydraulic fluid?",{"text":67,"@type":63},"Empty buckets were used to hold used hydraulic fluid; the buckets later contained used hydraulic fluid and were effectively introduced into the hospital cleaning process.",{"name":69,"@type":60,"acceptedAnswer":70},"How many patients were reported to be affected in the scenario?",{"text":71,"@type":63},"Approximately 3,650 patients were affected over a period of about two months.","https://schema.org",{"og:url":32,"og:type":74,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":76,"canonical":32},"index,follow",{"doc_id":78,"site_id":7},665400,1793302359,{"code":4,"msg":81,"data":82},"success",[83,87,91,95,100,105,110,114,119,122,126],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":84,"show_sort_weight":85,"slug":86},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":88,"show_sort_weight":89,"slug":90},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":92,"show_sort_weight":93,"slug":94},"Exam",70,"exam",{"id":96,"doc_module":4,"doc_module_name":25,"category_name":97,"show_sort_weight":98,"slug":99},5,"Comic",60,"comic",{"id":101,"doc_module":4,"doc_module_name":25,"category_name":102,"show_sort_weight":103,"slug":104},6,"Technology",50,"technology",{"id":106,"doc_module":4,"doc_module_name":25,"category_name":107,"show_sort_weight":108,"slug":109},7,"Healthcare",40,"healthcare",{"id":111,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":112,"slug":113},8,30,"research-report",{"id":115,"doc_module":4,"doc_module_name":25,"category_name":116,"show_sort_weight":117,"slug":118},9,"Religion & Spirituality",20,"religion-spirituality",{"id":117,"doc_module":4,"doc_module_name":25,"category_name":120,"show_sort_weight":117,"slug":121},"World Cup","world-cup",{"id":123,"doc_module":4,"doc_module_name":25,"category_name":124,"show_sort_weight":123,"slug":125},10,"Lifestyle","lifestyle",{"id":127,"doc_module":4,"doc_module_name":25,"category_name":128,"show_sort_weight":96,"slug":129},19,"General","general",{"code":4,"msg":81,"data":131},{"doc_id":78,"user_id":132,"nickname":42,"user_avatar":133,"doc_module":4,"category_id":111,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":22,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":139,"language":140,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":12,"update_tm":79,"read_time":144},962093541761,"https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0","George Bernstein, Ph. D.  \nAugust 2011  \n1  \nCopyright 2016 George Bernstein  \n¡ Introduction  \n¡ Warm-up exercises  \n§ Hydraulic Fluid  \n§ The Missed Appointment  \n¡ Definitions  \n¡ Root Cause Analysis and Methodologies  \n¡ Case Study  \n¡ Examples  \n¡ Q&A  \nAugust 2011  \n2  \nCopyright 2016 George Bernstein  \nDiscovery  \n| Animal\u003Cbr>Studies | | Investigational New Drug Application ( IND) | | Clinical Trials | | Regulatory\u003Cbr>Submission\u003Cbr>( NDA) | | Market Authorization |  |\n| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |\n|  |  |  |  |  |  |  | |  |  |\n\nSafety Monitoring  \nPre-Approval Inspection  \nAugust 2011  \n3  \nCopyright 2016 George Bernstein  \n• Principal with MAI Consulting  \n• Principal with Double Dragon Consulting (Asia)  \n• Ph.D. in Chemical Engineering  \n• 20+ years of Pharma experience, 2+ with FRI  \n• Wide range of experience:  \n– Quality Systems Development, Audits, Documentation, Investigations, Remediation (GMP, GLP, GCP, and GPP)  \n– Validation  \n– Project/Program Management  \n– Facility Construction and Commissioning  \n– Root Cause Analysis  \n– Business Process Re-engineering  \n• [Our websites:](Our websites: www.consultmai.com)[ ](Our websites: www.consultmai.com)[www.consultmai.com](Our websites: www.consultmai.com)  \n[www.doubledragonconsulting.com](www.doubledragonconsulting.com)  \nAugust 2011  \n4  \nCopyright 2016 George Bernstein  \n• Hydraulic Fluid  \n• The Missed Appointment  \nAugust 2011  \n5  \nCopyright 2016 George Bernstein  \nThis is an actual event that involves:  \n1. Automatic Elevator Co. of Durham  \n2. Duke University Hospital System (DUHS)  \n3. Cardinal Health  \n4. DUHS Staff  \n5. 3,650 Patients  \nAugust 2011  \n6  \nCopyright 2016 George Bernstein  \n¡ Hired by DUHS in September 2004 to repair an elevator  \n¡ Repair required replacement of hydraulic fluid  \n¡ Mechanics found empty buckets and used them to hold the used hydraulic fluid  \n¡ The buckets used to contain detergent used by DUHS to clean surgical instruments  \n¡ Buckets now containing used hydraulic fluid were left by Automatic Elevator at the hospital  \nAugust 2011  \n7  \nCopyright 2016 George Bernstein  \n¡ Buckets of hydraulic fluid were found and returned to DUHS central stores  \n¡ From central stores the hydraulic fluid was returned to Cardinal Health’s distribution warehouse  \n¡ Cardinal Health later distributed the hydraulic fluid to two of DUHS regional hospitals – Durham Regional Hospital and Duke Health Raleigh Hospital  \nAugust 2011  \n8  \nCopyright 2016 George Bernstein  \n¡ The hydraulic fluid was used by hospital staff to wash surgical instruments, prior to sterilization  \n¡ The hydraulic fluid was used for a period of 2 months  \nWhich one is the hydraulic fluid?  \nAugust 2011  \n9  \nCopyright 2016 George Bernstein  \n¡ The hydraulic fluid occasionally left the instruments feeling slightly oily  \n“It is not uncommon for instruments to feel slick, as a  \nlubricant is added during the normal cleaning process  \nto prevent rust and ensure the instruments work  \nsmoothly during surgery.”  \n¡ Approximately 3,650 patients were affected.  \nAugust 2011  \n10  \nCopyright 2016 George Bernstein","cbCaiaSSAF4SQ5PD","https://ap.wps.com/l/cbCaiaSSAF4SQ5PD","pdf",8388761,51,"English","# Introduction\n## Warm-up exercises\n## Definitions\n# Root Cause Analysis and Methodologies\n## Case Study\n## Examples\n## Q&A","[{\"question\":\"What incident is used in the case study to demonstrate root cause analysis?\",\"answer\":\"The case study follows an actual event involving an elevator repair that led to hydraulic fluid being used to wash surgical instruments before sterilization, affecting patients.\"},{\"question\":\"What was the root problem connected to the hydraulic fluid?\",\"answer\":\"Empty buckets were used to hold used hydraulic fluid; the buckets later contained used hydraulic fluid and were effectively introduced into the hospital cleaning process.\"},{\"question\":\"How many patients were reported to be affected in the scenario?\",\"answer\":\"Approximately 3,650 patients were affected over a period of about two months.\"}]","Clinical-Trials-and-Root-Cause-Analysis | PDF",129]