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Covers what must be filed, how Expected Document Lists (EDLs) and their items map to library documents, and when documents should be filed using milestones across the study lifecycle. Provides guidance on achieving “good” completeness through having a formal plan, tracking data and events affecting expected documentation, and leveraging system functionality for accurate, efficient workflows including EDL automation and handling unplanned study events.",{"@graph":63,"@context":101},[64,80],{"@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/best-practices-completeness-planning-and-tracking-jim-horstmann-brian-bialkowski/241489/",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/best-practices-completeness-planning-and-tracking-jim-horstmann-brian-bialkowski/241489.png","ImageObject",442,249,{"name":88,"@type":89},"Melati","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-14","2026-09-12",true,{"@type":98,"interactionType":99,"userInteractionCount":47},"InteractionCounter",{"@type":100},"ViewAction","https://schema.org",{"og:url":78,"og:type":103,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":105,"canonical":78},"index,follow",{"doc_id":107,"site_id":56},241489,1791747286,{"code":4,"msg":5,"data":110},{"doc_id":107,"user_id":111,"nickname":88,"user_avatar":112,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":113,"file_id":114,"file_url":115,"file_type":116,"file_size":117,"view_count":47,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":40,"language":118,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":119,"faqs":60,"seo_title":120,"seo_description":61,"update_tm":121,"read_time":122},962085570644,"https://ap-avatar.wpscdn.com/davatar_994ba38a5ba835b3df7d355c54d3ed8d","BEST PRACTICES:  \nCOMPLETENESS PLANNING AND TRACKING  \nJim Horstmann & Brian Bialkowski  \nVeeva Vault Product Management  \nSession Format Overview  \nVeeva Best Practices  \n15 Minutes  \nQ&A  \n15 Minutes  \nGroup Discussion  \n20 Minutes  \nCopyright © Veeva Systems 2024 2  \nVeeva Best Practices  \nCompleteness Overview in Vault eTMF  \nWhat should be filed  \nExpected Document Lists (EDLs) and items  \nWhat is filed  \nDocuments in the library, matched to the corresponding Expected Document item  \nWhen it should be filed by  \nMilestones, within which Expected Documents and their matched documents are associated  \nCopyright © Veeva Systems 2022 4  \nWhat Does Good Look Like in Vault eTMF?  \n1  \nHave a completeness plan and process  \nTrack data and events  \n 2  that affect expected documentation  \nin the system  \n3  \nLeverage system functionality  \nto make the process as accurate and efficient as possible  \nCopyright © Veeva Systems 2022 5  \nGeneral Completeness Setup in Vault eTMF  \n1~~ 2 3 4 5 ~~  \nReview  \nTMF Index  \nIdentify which document types are expected and their associated milestones  \nConfigure EDL Template  \nwhich will be associated with the study  \nDefine expected documents  \nwithin the EDL template  \nDefine  \nmilestone types  \nto indicate when each document is expected to be filed in the TMF  \nNew milestones created  \nas the study moves through its lifecycle (e.g., the milestone for study close will be created once the study moves to the closing state)  \nCopyright © Veeva Systems 2024 6  \nCompleteness Setup – Study Events  \nEstablish a process to track unplanned study events (e.g., protocol amendments)  \nThen leverage:  \n• Ad Hoc Events  \n• Site Personnel  \n• Organizations  \nCopyright © Veeva Systems 2024 7  \nFeature Highlight – EDL Automation  \nSite Personnel and Organization – EDL Automation  \nPerform with conditions  \n Study Team Role  Includes   \nIf  \nCopyright © Veeva Systems 2024 8  \nFeature Highlight – EDL Automation  \nSite Personnel and Organization – EDL Automation  \nworkspace\"  \n Perform with conditions  \n Study Team Role  Includes   \nIf  \n perform actions  \n Create Expected Documents  \nFeature Highlight – EDL Automation  \nSite Personnel and Organization – EDL Automation","cbCaimElgbxVfqg8","https://ap.wps.com/l/cbCaimElgbxVfqg8","pdf",1710798,"English","# Completeness Overview in Vault eTMF\n## What should be filed\n## Expected Document Lists (EDLs) and items\n## What is filed\n## When it should be filed by\n## Milestones and associations\n# What Does Good Look Like in Vault eTMF?\n## Completeness plan and process\n## Track data and events\n## Leverage system functionality\n# General Completeness Setup in Vault eTMF\n## TMF Index and document types\n## Configure EDL template and expected documents\n## Define milestone types\n## Create milestones across the study lifecycle\n# Completeness Setup – Study Events\n## Track unplanned study events\n## Use Ad Hoc Events, Site Personnel, Organizations\n# Feature Highlight – EDL Automation\n## Site Personnel and Organization automation","BEST PRACTICES: COMPlETENESS PLANNING AND TRACKING - Jim Horstmann & Brian Bialkowski | PDF",1789176077,6]