[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-165263-en":3,"doc-seo-165263-105":30,"detail-sidebar-cat-1-en-105":91},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":4,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":15,"update_tm":28,"read_time":29},165263,962085564549,"Aditya","https://ap-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45",1,17,"Forms","TRIAL MASTER FILE (TMF) PLAN - Approvals","Trial Master File (TMF) Plan template defining how trial records are set up, managed, stored, and controlled during and after study conduct. It specifies responsibilities for sponsor and other involved parties, including oversight and access arrangements, recordkeeping standards, and secure handling requirements compliant with ICH-GCP and local regulations. The plan also covers TMF maintenance, review processes, training, transfers, record disposition, and references applicable SOPs, ensuring consistent adherence across the study team.","[Instructions for use:\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.  After making adjustments to 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 entered with Arial Narrow font.\nTables have black headings with white font and are designed to split across pages.\nOVERVIEW 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 NAME]\n\u000f\n\u0003\u0013 TOC \\h \\u \\z \u0014\u0013 HYPERLINK \\l \"_Toc506893372\" \u00141\tApprovals\t\u0013 PAGEREF _Toc506893372 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893373\" \u00142\tDocument Version History\t\u0013 PAGEREF _Toc506893373 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893374\" \u00143\tDefinitions and Abbreviations\t\u0013 PAGEREF _Toc506893374 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893375\" \u00144\tIntroduction\t\u0013 PAGEREF _Toc506893375 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893376\" \u00145\tTMF Oversight & Access Arrangements\t\u0013 PAGEREF _Toc506893376 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893377\" \u00145.1\tRACI Matrix\t\u0013 PAGEREF _Toc506893377 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893378\" \u00145.2\tAccess arrangements\t\u0013 PAGEREF _Toc506893378 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893379\" \u00145.3\tTMF Maintenance delegated to a CRO/Vendor\t\u0013 PAGEREF _Toc506893379 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893380\" \u00145.4\tFor Inspections/Audits\t\u0013 PAGEREF _Toc506893380 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893381\" \u00146\tTMF Content\t\u0013 PAGEREF _Toc506893381 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893382\" \u00146.1\tTMF Format, Structure/Content Map/Specifications\t\u0013 PAGEREF _Toc506893382 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893383\" \u00146.2\tAuthoritative Sources\t\u0013 PAGEREF _Toc506893383 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893384\" \u00146.2.1\tOriginals, Wet Inks, and Raised Seals\t\u0013 PAGEREF _Toc506893384 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893385\" \u00146.2.2\tRelevant Correspondence\t\u0013 PAGEREF _Toc506893385 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893386\" \u00146.2.3\tUnblinded Records\t\u0013 PAGEREF _Toc506893386 \\h \u001413\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893387\" \u00146.2.4\tTranslations\t\u0013 PAGEREF _Toc506893387 \\h \u001413\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893388\" \u00147\tRecord and TMF Disposition\t\u0013 PAGEREF _Toc506893388 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893389\" \u00147.1\tDestruction\t\u0013 PAGEREF _Toc506893389 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893390\" \u00147.2\tRetention\t\u0013 PAGEREF _Toc506893390 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893391\" \u00147.3\tArchiving\t\u0013 PAGEREF _Toc506893391 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893392\" \u00147.3.1\tSponsor TMF\t\u0013 PAGEREF _Toc506893392 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893393\" \u00147.3.2\tInvestigator TMF\t\u0013 PAGEREF _Toc506893393 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893394\" \u00147.4\tLegal Hold\t\u0013 PAGEREF _Toc506893394 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893395\" \u00148\tApplicable SOPs\t\u0013 PAGEREF _Toc506893395 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893396\" \u00149\tTMF Training\t\u0013 PAGEREF _Toc506893396 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893397\" \u001410\tConducting TMF Reviews\t\u0013 PAGEREF _Toc506893397 \\h \u001418\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893398\" \u001410.1\tTMF Review Plan\t\u0013 PAGEREF _Toc506893398 \\h \u001418\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893399\" \u001410.2\tTMF Review Documentation\t\u0013 PAGEREF _Toc506893399 \\h \u001418\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893400\" \u001411\tTransfers of TMF\t\u0013 PAGEREF _Toc506893400 \\h \u001419\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc506893401\" \u001412\tAppendix\t\u0013 PAGEREF _Toc506893401 \\h \u001420\u0015\u0015\n\u0015\u0004\n\u000fApprovals\n[Approval and form of the approval is at the discretion of the sponsor authoring the TMF plan. Consideration should be given as to whom on the project should at a minimum agree to the terms of the TMF Plan.\nExample is provided below and can be removed if not needed or replaced by a simple approval statement.\nIf electronic signatures or approvals are in place then the below could simply state that.]\n\u000fDocument Version History","cbCaissCBC2AWYH6","https://ap.wps.com/l/cbCaissCBC2AWYH6","docx",60224,23,"English","en",105,"# Approvals\n# Document Version History\n# Definitions and Abbreviations\n# Introduction\n# TMF Oversight & Access Arrangements\n## RACI Matrix\n## Access arrangements\n## TMF Maintenance delegated to a CRO/Vendor\n## For Inspections/Audits\n# TMF Content\n## TMF Format, Structure/Content Map/Specifications\n## Authoritative Sources\n### Originals, Wet Inks, and Raised Seals\n### Relevant Correspondence\n### Unblinded Records\n### Translations\n# Record and TMF Disposition\n## Destruction\n## Retention\n## Archiving\n### Sponsor TMF\n### Investigator TMF\n## Legal Hold\n# Applicable SOPs\n# TMF Training\n# Conducting TMF Reviews\n## TMF Review Plan\n## TMF Review Documentation\n# Transfers of TMF\n# Appendix","[{\"question\":\"What is the purpose and scope of the TMF Plan?\",\"answer\":\"The TMF Plan outlines the process and procedures for managing and storing trial records to ensure high-quality TMF. It covers responsibilities for the sponsor and other involved parties and includes archiving and destruction processes, with guidance to align study team expectations.\"},{\"question\":\"Who is responsible for TMF setup and maintenance?\",\"answer\":\"The plan states that TMF setup and maintenance involve responsible parties described in a table. It also allows inclusion of vendor/CRO responsibilities when the TMF is managed externally.\"},{\"question\":\"How does the plan ensure TMF access is controlled during and after the trial?\",\"answer\":\"The document requires secure management of TMF records so access is controlled at all times. It includes oversight and access arrangement sections and procedures for audits/inspections and TMF review activities.\"}]","TRIAL MASTER FILE (TMF) PLAN - Approvals | DOCX",1788168536,8,{"code":4,"msg":31,"data":32},"ok",{"site_id":24,"language":23,"slug":33,"title":14,"keywords":34,"description":15,"schema_data":35,"social_meta":86,"head_meta":88,"extra_data":90,"updated_unix":28},"trial-master-file-tmf-plan-approvals","",{"@graph":36,"@context":85},[37,54,68],{"@type":38,"itemListElement":39},"BreadcrumbList",[40,44,48,51],{"item":41,"name":42,"@type":43,"position":11},"https://docshare.wps.com","Home","ListItem",{"item":45,"name":46,"@type":43,"position":47},"https://docshare.wps.com/template/","Template",2,{"item":49,"name":13,"@type":43,"position":50},"https://docshare.wps.com/template/forms/",3,{"item":52,"name":14,"@type":43,"position":53},"https://docshare.wps.com/template/trial-master-file-tmf-plan-approvals/165263/",4,{"url":52,"name":14,"@type":55,"author":56,"headline":14,"publisher":58,"fileFormat":61,"inLanguage":23,"description":15,"dateModified":62,"datePublished":62,"encodingFormat":61,"isAccessibleForFree":63,"interactionStatistic":64},"DigitalDocument",{"name":9,"@type":57},"Person",{"url":41,"name":59,"@type":60},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-08-31",true,{"@type":65,"interactionType":66,"userInteractionCount":4},"InteractionCounter",{"@type":67},"ViewAction",{"@type":69,"mainEntity":70},"FAQPage",[71,77,81],{"name":72,"@type":73,"acceptedAnswer":74},"What is the purpose and scope of the TMF Plan?","Question",{"text":75,"@type":76},"The TMF Plan outlines the process and procedures for managing and storing trial records to ensure high-quality TMF. It covers responsibilities for the sponsor and other involved parties and includes archiving and destruction processes, with guidance to align study team expectations.","Answer",{"name":78,"@type":73,"acceptedAnswer":79},"Who is responsible for TMF setup and maintenance?",{"text":80,"@type":76},"The plan states that TMF setup and maintenance involve responsible parties described in a table. It also allows inclusion of vendor/CRO responsibilities when the TMF is managed externally.",{"name":82,"@type":73,"acceptedAnswer":83},"How does the plan ensure TMF access is controlled during and after the trial?",{"text":84,"@type":76},"The document requires secure management of TMF records so access is controlled at all times. It includes oversight and access arrangement sections and procedures for audits/inspections and TMF review activities.","https://schema.org",{"og:url":52,"og:type":87,"og:title":14,"og:site_name":59,"og:description":15},"article",{"robots":89,"canonical":52},"index,follow",{"doc_id":7,"site_id":24},{"code":4,"msg":5,"data":92},[93,98,103,108,113,118,121,126,131],{"id":94,"doc_module":11,"doc_module_name":46,"category_name":95,"show_sort_weight":96,"slug":97},11,"Presentations",90,"presentations",{"id":99,"doc_module":11,"doc_module_name":46,"category_name":100,"show_sort_weight":101,"slug":102},12,"Resumes",80,"resumes",{"id":104,"doc_module":11,"doc_module_name":46,"category_name":105,"show_sort_weight":106,"slug":107},14,"Invoices",70,"invoices",{"id":109,"doc_module":11,"doc_module_name":46,"category_name":110,"show_sort_weight":111,"slug":112},15,"Posters",60,"posters",{"id":114,"doc_module":11,"doc_module_name":46,"category_name":115,"show_sort_weight":116,"slug":117},16,"Social Media",50,"social-media",{"id":12,"doc_module":11,"doc_module_name":46,"category_name":13,"show_sort_weight":119,"slug":120},40,"forms",{"id":122,"doc_module":11,"doc_module_name":46,"category_name":123,"show_sort_weight":124,"slug":125},18,"Letters",30,"letters",{"id":127,"doc_module":11,"doc_module_name":46,"category_name":128,"show_sort_weight":129,"slug":130},21,"Paper Templates",5,"papers-templates",{"id":132,"doc_module":11,"doc_module_name":46,"category_name":133,"show_sort_weight":4,"slug":134},158,"General","general-158"]