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Defines plan structure, required TMF content areas such as training, oversight and access, TMF format and signatures, correspondence, unblinded records, translations, living documents, reviews, disposition, archiving, legal hold, and transfer/archival procedures.",{"@graph":14,"@context":73},[15,34,56],{"@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/template/","Template",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/template/presentations/","Presentations",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/template/trial-master-file-tmf-plan-template/163071/",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/trial-master-file-tmf-plan-template/163071.png","ImageObject",442,249,{"name":42,"@type":43},"Finn","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-29","2026-08-31",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",5,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What is the purpose of the TMF Plan template?","Question",{"text":63,"@type":64},"It provides a structured, adaptable framework for Sponsors and CROs to document TMF requirements using consortium best practices rather than reflecting regulatory requirements directly.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"What text should be removed or completed before finalization?",{"text":68,"@type":64},"Green instructional guidance must be removed, and blue bold/italic placeholders indicate where expected content should be completed.",{"name":70,"@type":61,"acceptedAnswer":71},"Why must the Table of Contents be updated after edits?",{"text":72,"@type":64},"Edits can change page numbers, so the Table of Contents page 2 must be updated to ensure page references remain accurate.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},163071,1788136986,{"code":4,"msg":82,"data":83},"success",[84,88,93,98,103,108,113,118,122],{"id":85,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":86,"slug":87},11,90,"presentations",{"id":89,"doc_module":22,"doc_module_name":25,"category_name":90,"show_sort_weight":91,"slug":92},12,"Resumes",80,"resumes",{"id":94,"doc_module":22,"doc_module_name":25,"category_name":95,"show_sort_weight":96,"slug":97},14,"Invoices",70,"invoices",{"id":99,"doc_module":22,"doc_module_name":25,"category_name":100,"show_sort_weight":101,"slug":102},15,"Posters",60,"posters",{"id":104,"doc_module":22,"doc_module_name":25,"category_name":105,"show_sort_weight":106,"slug":107},16,"Social Media",50,"social-media",{"id":109,"doc_module":22,"doc_module_name":25,"category_name":110,"show_sort_weight":111,"slug":112},17,"Forms",40,"forms",{"id":114,"doc_module":22,"doc_module_name":25,"category_name":115,"show_sort_weight":116,"slug":117},18,"Letters",30,"letters",{"id":119,"doc_module":22,"doc_module_name":25,"category_name":120,"show_sort_weight":55,"slug":121},21,"Paper Templates","papers-templates",{"id":123,"doc_module":22,"doc_module_name":25,"category_name":124,"show_sort_weight":4,"slug":125},158,"General","general-158",{"code":4,"msg":82,"data":127},{"doc_id":79,"user_id":128,"nickname":42,"user_avatar":129,"doc_module":22,"category_id":85,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":135,"language":136,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":12,"update_tm":80,"read_time":140},34359740700684,"https://ap-avatar.wpscdn.com/avatar/1f400023980c374ae676?_k=1777273430885731487","[Instructions for use:\nThe intention of this template is to share the collective experience of the members of the TMF Reference Model Project, a wholly volunteer consortium.   The content does not reflect regulatory requirements, rather, shares the real-life knowledge of the consortium and is meant to be adapted to the appropriate scenario.\nThis template may be adopted for Sponsor, CRO, or Sponsor/CRO TMF Plan, it may be dependent on study structure, and relationship with CRO.  The components of this Plan should be covered no matter if it is the Sponsor, CRO, or combination of both.  A Sponsor may be one of the following/t not limited to: a pharma, biotech, or investigator, depending on the type of trial.\nEach company may utilize their own practices; however, if SOPs or Plans are mentioned in the TMF Plan should also be accessible.\nGreen text is instructional guidance on how to complete the TMF Plan and must be removed prior to finalization.\nBlue bold/italicized text is where expected content should be completed.\nThis document has a page break for every section, which you may choose to remove to make the document less pages.\nAfter adjusting this document, and removing green text, you will need to Update the Table of Contents table on page 2 so that the page numbers are accurate.\nThe entire plan is written with Arial Narrow font and majority of text font size is 11 except headings.\nTables have black headings with white font and are designed to split across pages; font size for the tables is 10.\nThe Paragraph Show/Hide is on, so that you can see all the pagination, tables, etc.  You should turn this off once you are comfortable with the template.\nUpdate the header and footer for this page as appropriate for your company.\nEND Instructional text]\n[OVERVIEW PAGE to be completed by initiator of the TMF Plan and fill in as much detail as possible.  Change Headers/Footers to match your sponsor information and following your sponsor practices/formats.\nTRIAL MASTER FILE (TMF) PLAN\n[ENTER Sponsor/CRO Name]\n\u000f\n\u0003\u0013 TOC \\h \\u \\z \u0014\u0013 HYPERLINK \\l \"_Toc117252305\" \u00141\tApprovals\t\u0013 PAGEREF _Toc117252305 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252306\" \u00142\tDocument Version History\t\u0013 PAGEREF _Toc117252306 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252307\" \u00143\tDefinitions and Abbreviations\t\u0013 PAGEREF _Toc117252307 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252308\" \u00144\tIntroduction\t\u0013 PAGEREF _Toc117252308 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252309\" \u00145\tApplicable SOPs\t\u0013 PAGEREF _Toc117252309 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252310\" \u00145.1\tSponsor Specific\t\u0013 PAGEREF _Toc117252310 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252311\" \u00145.2\tVendor/CRO Specific\t\u0013 PAGEREF _Toc117252311 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252312\" \u00146\tTMF Training\t\u0013 PAGEREF _Toc117252312 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252313\" \u00147\tTMF Oversight & Access Arrangements\t\u0013 PAGEREF _Toc117252313 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252314\" \u00147.1\tResponsibilities\t\u0013 PAGEREF _Toc117252314 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252315\" \u00147.2\tAccess arrangements\t\u0013 PAGEREF _Toc117252315 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252316\" \u00147.3\tCRO/Vendor\t\u0013 PAGEREF _Toc117252316 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252317\" \u00147.4\tFor Inspections\t\u0013 PAGEREF _Toc117252317 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252318\" \u00148\tTMF Content\t\u0013 PAGEREF _Toc117252318 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252319\" \u00148.1\tTMF Format, Structure/Content Map/Specifications\t\u0013 PAGEREF _Toc117252319 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252320\" \u00148.2\tE-Signatures, Originals, Wet Inks, and Raised Seals\t\u0013 PAGEREF _Toc117252320 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252321\" \u00148.3\tRelevant Correspondence\t\u0013 PAGEREF _Toc117252321 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252322\" \u00148.4\tUnblinded Records\t\u0013 PAGEREF _Toc117252322 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252323\" \u00148.5\tTranslations\t\u0013 PAGEREF _Toc117252323 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252324\" \u00148.6\tLiving/Fluid Documents\t\u0013 PAGEREF _Toc117252324 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252325\" \u00149\tConducting TMF Reviews\t\u0013 PAGEREF _Toc117252325 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc117252326\" \u00149.1\tTMF Review Plan\t\u0013 PAGEREF _Toc11725","cbCaicDXyZiaJTNM","https://ap.wps.com/l/cbCaicDXyZiaJTNM","docx",112757,25,"English","# TRIAL MASTER FILE (TMF) PLAN\n## Document Version History\n## Definitions and Abbreviations\n## Introduction\n## Applicable SOPs\n## Sponsor Specific\n## Vendor/CRO Specific\n## TMF Training\n## TMF Oversight & Access Arrangements\n## Responsibilities\n## Access arrangements\n## CRO/Vendor\n## For Inspections\n## TMF Content\n## TMF Format, Structure/Content Map/Specifications\n## E-Signatures, Originals, Wet Inks, and Raised Seals\n## Relevant Correspondence\n## Unblinded Records\n## Translations\n## Living/Fluid Documents\n## Conducting TMF Reviews\n## TMF Review Plan\n## TMF Review Documentation\n## Record and TMF Disposition\n## Archiving\n## Sponsor TMF at CRO/Vendor\n## Investigator Site File\n## Retention by CRO or Vendor\n## Legal Hold\n## Destruction by CRO or Vendor\n## Transfer and Archival of TMF\n## Appendix","[{\"question\":\"What is the purpose of the TMF Plan template?\",\"answer\":\"It provides a structured, adaptable framework for Sponsors and CROs to document TMF requirements using consortium best practices rather than reflecting regulatory requirements directly.\"},{\"question\":\"What text should be removed or completed before finalization?\",\"answer\":\"Green instructional guidance must be removed, and blue bold/italic placeholders indicate where expected content should be completed.\"},{\"question\":\"Why must the Table of Contents be updated after edits?\",\"answer\":\"Edits can change page numbers, so the Table of Contents page 2 must be updated to ensure page references remain accurate.\"}]","Trial Master File (TMF) Plan - Template | DOCX",9]