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The learning content covers risk assessment and a monitoring plan built on a monitoring risk level tool and ICH GCP E6 (R3) risk-proportionality principles. It explains initial, routine, and close-out monitoring visits, key monitoring metrics, and common observations to support protocol compliance, data integrity, and participant safety.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/monitoring-services-risk-assessment-monitoring-plan-learning-objectives/243957/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/monitoring-services-risk-assessment-monitoring-plan-learning-objectives/243957.png","ImageObject",442,249,{"name":88,"@type":89},"Berry Peter","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-19","2026-09-12",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",9,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"Who can access Monitoring Services and what study types are included?","Question",{"text":109,"@type":110},"The service is available to all University of Calgary researchers conducting Investigator-Initiated Trials (IITs). It covers drug and device trials.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"How is the monitoring plan determined?",{"text":114,"@type":110},"The plan uses a monitoring risk level tool adapted from an N2-endorsed tool and aligns with ICH GCP E6 (R3) risk-proportionality. SDV frequency and amount are based on risk assessment and Critical to Quality Factors (CtQs).",{"name":116,"@type":107,"acceptedAnswer":117},"What are the main differences between initial, routine, and close-out monitoring visits?",{"text":118,"@type":110},"Initial visits focus on setup for success, essential documents, and completed required training. Routine visits assess compliance, ensure accurate data collection, and address issues promptly. Close-out visits confirm completion of outstanding CRFs and queries, manage study drug/device disposition, and perform a final file and record-retention review.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},243957,1791725507,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":20,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":47},1374402524268,"https://ap-avatar.wpscdn.com/davatar_3d24733baf745e90a7e4bdd5f77d97b2","Monitoring Services  \nCalgary Centre for Clinical Research  \nShweta Patel, MBBS, CCRP  \nSenior Clinical Trial Program Administrator/Monitor  \nFebruary 23, 2026  \nLearning objectives  \n• Overview of Monitoring Services  \n• Risk Assessment & Monitoring Plan  \n• Types of Monitoring Visits  \n• Review Report and Follow-up  \n• Common observations and insight into possible solutions  \nOverview of Monitoring Services  \n• Available to all researchers conducting Investigator-Initiated Trials (IITs), sponsored by the University of Calgary  \n• Drug and Device trials  \n• Offered on a fee for service basis  \n• Cost estimates for grant application  \nMonitoring Plan  \n• Monitoring Risk Level Tool adapted from an N2 endorsed tool utilized across Canada  \n• ICH GCP E6 (R3) guideline focus on risk-proportionality  \n• Both frequency and amount of SDV are based on risk assessment & Critical to Quality Factors(CtQs)  \nRisk Assessment  \nFactors considered are below  \n• Study objective, endpoints, and design complexity,• Blinding, and number of trial participants,  \n• Investigational product, and current knowledge of the safety profile  \n• Experience of study team  \nInitial monitoring visit  \n• Ensure a team is set up for success  \n• Essential Documents in place  \n• Completed required training  \nRoutine monitoring visit  \n• To assess compliance with the protocol, GCP and regulatory requirements  \n• Ensuring accurate and complete data collection  \n• Identifying and addressing any issues promptly to protect participant safety and data integrity  \nClose-out visit  \n• Ensure the completion of outstanding CRFs and queries  \n• Return or destruction of study drug/devise  \n• Perform a final review of the study file documents  \n• Review the plans for record retention  \nMonitoring Metrics  \n2024 in review:  \n• 9 studies monitored  \n• 6 different sites in 2 cities,➢ Calgary, Sunnybrook  \n• 32 participants files monitored  \n• 4 initial visits and 17 Routine interim visits  \n2025 in review:  \n• 15 studies monitored  \n• 7 different sites in 4 cities  \n➢ Calgary, Edmonton,  \nOttawa, Burnaby  \n• 40 visits  \n➢ 8 Initial Visits  \n➢ 24 Routine Interim Visits  \n➢ 3 close out visits  \n• 92 participant files reviewed","cbCaii1q2vUDbjOv","https://ap.wps.com/l/cbCaii1q2vUDbjOv","pdf",375749,"English","# Learning objectives\n## Overview of Monitoring Services\n## Risk Assessment & Monitoring Plan\n## Types of Monitoring Visits\n## Review Report and Follow-up\n## Common observations and insight into possible solutions\n# Monitoring Plan\n## Monitoring Risk Level Tool and ICH GCP E6 (R3)\n## SDV frequency and amount based on risk assessment and CtQs\n# Risk Assessment\n## Factors considered\n# Types of Monitoring Visits\n## Initial monitoring visit\n## Routine monitoring visit\n## Close-out visit\n# Monitoring Metrics\n## 2024 in review\n## 2025 in review","[{\"question\":\"Who can access Monitoring Services and what study types are included?\",\"answer\":\"The service is available to all University of Calgary researchers conducting Investigator-Initiated Trials (IITs). It covers drug and device trials.\"},{\"question\":\"How is the monitoring plan determined?\",\"answer\":\"The plan uses a monitoring risk level tool adapted from an N2-endorsed tool and aligns with ICH GCP E6 (R3) risk-proportionality. SDV frequency and amount are based on risk assessment and Critical to Quality Factors (CtQs).\"},{\"question\":\"What are the main differences between initial, routine, and close-out monitoring visits?\",\"answer\":\"Initial visits focus on setup for success, essential documents, and completed required training. Routine visits assess compliance, ensure accurate data collection, and address issues promptly. Close-out visits confirm completion of outstanding CRFs and queries, manage study drug/device disposition, and perform a final file and record-retention review.\"}]","Monitoring Services - Risk Assessment & Monitoring Plan - Learning Objectives | PDF",1789210291]