[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-189343-105":53,"doc-detail-189343-en":127},{"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":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","informed-consent-form-addendum","Informed Consent Form Addendum","","This document details an amendment to an Informed Consent Form (ICF), specifically adding a new reason for participant removal from a study. The new clause, section 7, states that a participant may be removed if the study drug becomes available through specific support programs in their country. This amendment is applicable to participants in Brazil, France, Germany, India, Italy, Malaysia, Mexico, Peru, and Thailand. The amendment aims to clarify the conditions under which a participant's involvement in the study may be terminated, ensuring transparency and adherence to ethical guidelines. This change is crucial for maintaining the integrity of the research and protecting the rights and well-being of study participants by preemptively addressing potential conflicts or changes in study drug accessibility.",{"@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":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/informed-consent-form-addendum/189343/",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/informed-consent-form-addendum/189343.png","ImageObject",442,249,{"name":88,"@type":89},"Felix Montgomery","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-09-23","2026-09-03",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",6,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What is the purpose of this document?","Question",{"text":109,"@type":110},"This document is an amendment to an Informed Consent Form, adding a new reason for removing a participant from a study.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"What is the new reason for participant removal?",{"text":114,"@type":110},"A participant may be removed if the study drug becomes available through specific support programs in their country.",{"name":116,"@type":107,"acceptedAnswer":117},"In which countries is this amendment applicable?",{"text":118,"@type":110},"This amendment is applicable to Brazil, France, Germany, India, Italy, Malaysia, Mexico, Peru, and Thailand.","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},189343,1788396134,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":35,"category_name":36,"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":30,"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":126,"read_time":101},549768064778,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","| Section | Brief description of new change and/or new text |\n| --- | --- |\n| Informed consent | A new reason has been added in this Informed Consent Form to explain when the study doctor may remove you from this study:\u003Cbr>7. The study drug has become available through specific support programmes in your country.\u003Cbr>This ICF amendment is applicable to Brazil, France, Germany, India, Italy, Malaysia, Mexico, Peru and Thailand. |","cbCaiigFV54SAOhK","https://ap.wps.com/l/cbCaiigFV54SAOhK","pdf",338985,"English","# Informed Consent\n## New Reason for Removal","[{\"question\":\"What is the purpose of this document?\",\"answer\":\"This document is an amendment to an Informed Consent Form, adding a new reason for removing a participant from a study.\"},{\"question\":\"What is the new reason for participant removal?\",\"answer\":\"A participant may be removed if the study drug becomes available through specific support programs in their country.\"},{\"question\":\"In which countries is this amendment applicable?\",\"answer\":\"This amendment is applicable to Brazil, France, Germany, India, Italy, Malaysia, Mexico, Peru, and Thailand.\"}]","Informed Consent Form Addendum | PDF"]