[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-170522-105":53,"doc-detail-170522-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","investigators-brochure-template","Investigator’s Brochure - Template","","Investigator’s Brochure (IB) template outlining sponsor identification of each investigational product, including research number, chemical or approved generic name, and permitted trade names, along with edition and release date details. Provides a structured framework for documenting the development rationale, physical/chemical/pharmaceutical properties, nonclinical studies, and human effects covering pharmacokinetics, pharmacodynamics, efficacy, and safety including evaluations, adverse events, and laboratory assessments. Includes marketing experience, investigator guidance, and appendices for reference safety information and clinical study tables.",{"@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/investigators-brochure-template/170522/",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/investigators-brochure-template/170522.png","ImageObject",442,249,{"name":88,"@type":89},"Felix Montgomery","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-22","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",35,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What key identifiers must be provided for each investigational product in the Investigator’s Brochure?","Question",{"text":109,"@type":110},"Provide the sponsor’s name and the identity of each investigational product, including the research number, chemical or approved generic name, and any trade names where legally permissible.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"Why should an edition number and a release date be included?",{"text":114,"@type":110},"The template recommends including an edition number and the release date, along with a reference to the prior edition that the new edition supersedes, to support version control.",{"name":116,"@type":107,"acceptedAnswer":117},"What sections are required to describe effects in humans?",{"text":118,"@type":110},"The template organizes human information into clinical pharmacology and efficacy, plus safety details such as adverse events, deaths/serious adverse events/discontinuations due to adverse events, and clinical laboratory evaluations.","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},170522,1790262497,{"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":136,"language":137,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":61,"update_tm":141,"read_time":20},549768064778,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","1.14.4.1 \u0005INVESTIGATOR’S BROCHURE\nThis should provide the sponsor's name, the identity of each investigational product (i.e., research number, chemical or approved generic name, and trade name(s) where legally permissible and desired by the sponsor), and the release date. It is also suggested that an edition number, and a reference to the number and date of the edition it supersedes, be provided. An example is given in Appendix 1.\n\u0013 MACROBUTTON EmptyMacro [Insert Study Drug Name Here]\u0015\n\u0013 DATE  \\@ \"d MMMM yyyy\"  \\* MERGEFORMAT \u00141 September 2026\u0015\nLineberger Comprehensive Cancer Center\nUniversity of North Carolina\n450 West Drive, CB 7295\nChapel Hill, NC 27599\nEdition:\n\u0013 MACROBUTTON  AcceptAllChangesInDocAndStopTracking \"[Insert Edition Number Here]\" \u0015\nRelease Date:\n\u0013 MACROBUTTON  AcceptAllChangesInDocAndStopTracking \"[Insert Release Date Here]\" \u0015\nSYNOPSIS OF CHANGES TO THE INVESTIGATOR’S BROCHURE\n\u0013 MACROBUTTON EmptyMacro [Insert Product Name]\u0015\u000bEdition #: \u0013 DATE  \\@ \"d MMMM yyyy\"  \\* MERGEFORMAT \u00141 September 2026\u0015\n\u0013 MACROBUTTON EmptyMacro [Insert synopsis of changes since previous version.  If none, delete this page.]\u0015\nOverall Risk-Benefit\nWith the changes introduced in this edition of the IB, the risk/benefit assessment\u0005\nTABLE OF CONTENTS\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc529271435\" \u00141\tOVERVIEW\t\u0013 PAGEREF _Toc529271435 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271436\" \u00141.1\tProduct Summary\t\u0013 PAGEREF _Toc529271436 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271437\" \u00141.1.1\tDevelopment Rationale\t\u0013 PAGEREF _Toc529271437 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271438\" \u00142\tPHYSICAL, CHEMICAL, AND PHARMACEUTICAL PROPERTIES AND FORMULATION\t\u0013 PAGEREF _Toc529271438 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271439\" \u00142.1\tDrug Substance\t\u0013 PAGEREF _Toc529271439 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271440\" \u00142.2\tDrug Product\t\u0013 PAGEREF _Toc529271440 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271441\" \u00142.2.1\tFormulation\t\u0013 PAGEREF _Toc529271441 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271442\" \u00142.2.2\tLabeling, Storage, and Handling\t\u0013 PAGEREF _Toc529271442 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271443\" \u00142.2.3\tStability\t\u0013 PAGEREF _Toc529271443 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271444\" \u00143\tNONCLINICAL STUDIES\t\u0013 PAGEREF _Toc529271444 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271445\" \u00143.1\tOverview\t\u0013 PAGEREF _Toc529271445 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271446\" \u00143.2\tDetailed Non-Clinical Study Description\t\u0013 PAGEREF _Toc529271446 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271447\" \u00144\tEFFECTS IN HUMANS\t\u0013 PAGEREF _Toc529271447 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271448\" \u00144.1\tOverview\t\u0013 PAGEREF _Toc529271448 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271449\" \u00144.1.1\tClinical Studies\t\u0013 PAGEREF _Toc529271449 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271450\" \u00144.2\tClinical Pharmacology\t\u0013 PAGEREF _Toc529271450 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271451\" \u00144.2.1\tPharmacokinetics in Subjects\t\u0013 PAGEREF _Toc529271451 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271452\" \u00144.2.2\tOther Pharmacokinetic Analyses\t\u0013 PAGEREF _Toc529271452 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271453\" \u00144.2.3\tClinical Pharmacodynamics\t\u0013 PAGEREF _Toc529271453 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271454\" \u00144.3\tEfficacy in Subjects\t\u0013 PAGEREF _Toc529271454 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271455\" \u00144.3.1\tDemographics and Baseline Characteristics\t\u0013 PAGEREF _Toc529271455 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271456\" \u00144.3.2\tTime to Clinical Worsening\t\u0013 PAGEREF _Toc529271456 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271457\" \u00144.3.3\tSurvival\t\u0013 PAGEREF _Toc529271457 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271458\" \u00144.4\tSafety\t\u0013 PAGEREF _Toc529271458 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271459\" \u00144.4.1\tSafety Evaluations \u001e Methodology and Definitions\t\u0013 PAGEREF _Toc529271459 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271460\" \u00144.4.2\tAdverse Events\t\u0013 PAGEREF _Toc529271460 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271461\" \u00144.4.3\tDeaths, Serious Adverse Events, and Discontinuations Due to Adverse Events\t\u0013 PAGEREF _Toc529271461 \\h \u001418\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271462\" \u00144.4.4\tClinical Laboratory Evaluations\t\u0013 PAGEREF _Toc529271462 \\h \u001418\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc529271463\" \u00144.4.5\tOther Safety Evaluations\t\u0013 PAGEREF","cbCaieOR2wGdRF8a","https://ap.wps.com/l/cbCaieOR2wGdRF8a","docx",110538,41,"English","# INVESTIGATOR’S BROCHURE\n# SYNOPSIS OF CHANGES TO THE INVESTIGATOR’S BROCHURE\n# OVERVIEW\n## Product Summary\n## Development Rationale\n# PHYSICAL, CHEMICAL, AND PHARMACEUTICAL PROPERTIES AND FORMULATION\n## Drug Substance\n## Drug Product\n## Formulation\n## Labeling, Storage, and Handling\n## Stability\n# NONCLINICAL STUDIES\n## Overview\n## Detailed Non-Clinical Study Description\n# EFFECTS IN HUMANS\n## Overview\n## Clinical Studies\n## Clinical Pharmacology\n## Pharmacokinetics in Subjects\n## Other Pharmacokinetic Analyses\n## Clinical Pharmacodynamics\n## Efficacy in Subjects\n## Demographics and Baseline Characteristics\n## Time to Clinical Worsening\n## Survival\n## Safety\n## Safety Evaluations, Methodology and Definitions\n## Adverse Events\n## Deaths, Serious Adverse Events, and Discontinuations Due to Adverse Events\n## Clinical Laboratory Evaluations\n## Other Safety Evaluations\n# MARKETING EXPERIENCE\n# GUIDANCE FOR THE INVESTIGATORS\n## Indication\n## Product\n## Safety\n## Infusion of T-cells\n## Transduction\n## Cross-Reactivity with Normal Tissues\n## CRS\n## MAS\n## Tumor Lysis Syndrome\n## Development of Human Anti-Mouse Antibody (HAMA)\n## Clinical Studies\n# Appendix 1. REFERNCE SAFETY INFORMATION (RSI)\n# Appendix 2. TABULAR SUMMARY OF CLINICAL STUDIES","[{\"question\":\"What key identifiers must be provided for each investigational product in the Investigator’s Brochure?\",\"answer\":\"Provide the sponsor’s name and the identity of each investigational product, including the research number, chemical or approved generic name, and any trade names where legally permissible.\"},{\"question\":\"Why should an edition number and a release date be included?\",\"answer\":\"The template recommends including an edition number and the release date, along with a reference to the prior edition that the new edition supersedes, to support version control.\"},{\"question\":\"What sections are required to describe effects in humans?\",\"answer\":\"The template organizes human information into clinical pharmacology and efficacy, plus safety details such as adverse events, deaths/serious adverse events/discontinuations due to adverse events, and clinical laboratory evaluations.\"}]","Investigator’s Brochure - Template | DOCX",1788272580]