[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-171391-105":53,"doc-detail-171391-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","ctsi-lost-to-follow-up-guidance-template-2024-09-03","CTSI Lost to Follow-up Guidance - Template 2024-09-03","","CTSI Lost to Follow-up Guidance provides protocol-ready requirements for defining and managing participants who cannot be located or contacted. It outlines qualification criteria, specifies how lost to follow-up data may be handled in analyses (including case-wise deletions, multiple imputation, or use of partial information), and links loss rates to potential bias. The guidance also establishes documentation expectations for contact attempts and due diligence, using defined methods and timelines. It clarifies how to treat refusals and withdrawals as distinct from lost to follow-up and recommends descriptive reporting per ICH E9.",{"@graph":63,"@context":118},[64,80,101],{"@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":41,"@type":70,"position":76},"https://docshare.wps.com/template/letters/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/ctsi-lost-to-follow-up-guidance-template-2024-09-03/171391/",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/ctsi-lost-to-follow-up-guidance-template-2024-09-03/171391.png","ImageObject",442,249,{"name":88,"@type":89},"Theodora","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-19","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":47},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"How should a participant be qualified as “lost to follow-up” in a research protocol?","Question",{"text":108,"@type":109},"Protocols must state the specific requirements/actions needed before a subject can be considered lost to follow-up. They should also define what happens to lost-to-follow-up data and whether it will be included in the data analysis.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What data analysis approaches are suggested for participants lost to follow-up?",{"text":113,"@type":109},"Options include case-wise deletions, multiple imputation for missing follow-up values, and including partial information in analyses (e.g., repeated measures). Loss rates should be considered, since \u003C5% typically leads to little bias while >20% threatens validity.",{"name":115,"@type":106,"acceptedAnswer":116},"What documentation is required for contact and due diligence attempts?",{"text":117,"@type":109},"Each contact attempt must be documented, including phone calls and permitted emails or IRB-approved written materials. Due diligence actions to locate a participant or verify living status must also be documented, and outreach may continue until the anticipated study end date.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},171391,1790478522,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":40,"category_name":41,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":47,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":76,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":139,"read_time":9},687197207919,"https://ap-avatar.wpscdn.com/avatar/a000253d6f5f7c60be?x-image-process=image/resize,m_fixed,w_180,h_180&k=1779446848396160552","CTSI Lost to Follow-Up Guidance\nOverview:\nAll study visits and procedures must be completed as outlined in the protocol and the specified timeframes to ensure subject/participant safety and validity of the data analysis.\nActively enrolled subjects who are unable to be located/contacted may be considered “lost to follow-up”. Research protocols should include:\nthe specific requirements/actions needed before a subject can be considered “lost to follow-up.”\nwhat will happen to the lost to follow-up subject’s data and whether the data will be included in the data analysis. (NOTE: \u003C5% loss leads to little bias, while >20% poses serious threats to validity). These issues should be included in the Data Safety and Monitoring Plan (DSMP).\ncase-wise deletions (subjects lost to follow-up not included in analyses\nmultiple imputation (missing follow-up values are imputed)\npartial information included in the analyses (example with repeated measures, you can use the data you have available for analysis)\nProtocols that do not include guidance for lost to follow up qualifications may utilize:\nan established team policy/process\n\u0013 HYPERLINK \"https://www.allianceforclinicaltrialsinoncology.org/main/cmsfile?cmsPath=/Public/Governance/files/Alliance%208%20Data%20Management%20clean%20January%201%202018.pdf\" \u0014“Alliance 8 Data Management v Jan 1, 2018: (section 8.1.2.5 Confirmation of lost to follow-up status)”\u0015 (has a 2-year contact requirement)\nother reference materials identified by the study team/study sponsor\nStudy subjects who have refused to partake in certain aspects of study participation or who have withdrawn consent from further participation are not considered “lost to follow-up\".\nNOTE: \u0013 HYPERLINK \"https://database.ich.org/sites/default/files/E9_Guideline.pdf\" \u0014ICH E9 \"Statistical Principals for Clinical Trials\"\u0015 suggests that the effect of losses of subjects or data, withdrawals from treatment, and major protocol violations on the main analyses of the primary variable(s) should be considered carefully, and that any subjects lost to follow-up, withdrawn from treatment, or with severe protocol violation should be identified, and a descriptive analysis of them provided, including the reasons for their loss and its relationship to treatment outcome.\nContact Actions:\nEach attempt to contact the patient needs to be documented.  Contact attempts may include:\nPhone calls\nEmail, if permissible (template must be IRB approved)\nMailing certified letter to the subject’s last known address (template must be IRB approved)\nContacting the primary care physician (PCP) – if permitted in the consent form\nContact people listed for the subject, if permitted in the Informed Consent Form (I.e., family member(s) and/or next of kin)\nNOTE: Any written materials (written letters, emails, MyChart messages, etc.) that are distributed to the subject must be IRB approved prior to distribution.\nDue Diligence Actions:\nEach due diligence attempt to locate a participant or verify their living status needs to be documented.  Due Diligence attempts may include:\nEMR review\nReviewing public records (internet search, newspaper articles) such as obituaries or the “Office of Vital Statistics” for death records\nDuration of Contact and Due Diligence Actions\nIn most cases, three attempts to contact the subject with one including a certified letter, may be considered reasonable to identify the participant as lost to follow-up.\nContact actions and due diligence actions may need to be completed until the participants anticipated study participation end date.\nComing into Contact with a Lost to Follow-up Participant\nIf the research team comes into contact with a lost to follow up participant, the research team should document the following:\nThe type of contact made and how the contact came about (example: the participant called the study team, or the participant came into clinic for an alternative treatment plan)\nThe reason the participant was unable to be contacted (the participant was h","cbCaigsXyPNfTcIA","https://ap.wps.com/l/cbCaigsXyPNfTcIA","docx",225101,"English","# Overview\n## Data analysis handling of lost to follow-up\n# Contact Actions\n## Documentation requirements\n# Due Diligence Actions\n## Verification of living status\n# Duration of contact and due diligence\n# Coming into contact with a lost to follow-up participant\n# Example Letter Template","[{\"question\":\"How should a participant be qualified as “lost to follow-up” in a research protocol?\",\"answer\":\"Protocols must state the specific requirements/actions needed before a subject can be considered lost to follow-up. They should also define what happens to lost-to-follow-up data and whether it will be included in the data analysis.\"},{\"question\":\"What data analysis approaches are suggested for participants lost to follow-up?\",\"answer\":\"Options include case-wise deletions, multiple imputation for missing follow-up values, and including partial information in analyses (e.g., repeated measures). Loss rates should be considered, since \\u003c5% typically leads to little bias while \\u003e20% threatens validity.\"},{\"question\":\"What documentation is required for contact and due diligence attempts?\",\"answer\":\"Each contact attempt must be documented, including phone calls and permitted emails or IRB-approved written materials. Due diligence actions to locate a participant or verify living status must also be documented, and outreach may continue until the anticipated study end date.\"}]","CTSI Lost to Follow-up Guidance - Template 2024-09-03 | DOCX",1788282441]