[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-161034-105":53,"doc-detail-161034-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","jrmo-clinical-investigation-plan-cip-template-clinical-investigation-plan-structure-template","JRMO Clinical Investigation Plan (CIP) Template - Clinical investigation plan structure template","","JRMO Clinical Investigation Plan (CIP) Template provides a structured framework for documenting key elements of a clinical investigation, from study titles and sponsor information to study contacts, laboratories, and central facilities. It includes guidance for tailoring wording for multi-country studies and inserting “n/a” where sections do not apply. The template further organizes required content such as synopsis, introduction, background and risk assessment, objectives, endpoints, and study design, supporting consistent review and management.",{"@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":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/jrmo-clinical-investigation-plan-cip-template-clinical-investigation-plan-structure-template/161034/",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/jrmo-clinical-investigation-plan-cip-template-clinical-investigation-plan-structure-template/161034.png","ImageObject",442,249,{"name":88,"@type":89},"Sage","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-27","2026-08-30",true,{"@type":98,"interactionType":99,"userInteractionCount":76},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the purpose of the JRMO Clinical Investigation Plan (CIP) template?","Question",{"text":108,"@type":109},"It is a structured framework for documenting essential clinical investigation information, enabling consistent review and study management across required sections.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How should template guidance text be handled?",{"text":113,"@type":109},"Green template text is guidance and should be removed and replaced with trial-specific information; sections not applicable should use “n/a”.",{"name":115,"@type":106,"acceptedAnswer":116},"What sections are included for trial objectives and outcomes?",{"text":117,"@type":109},"The template contains sections for primary and secondary objectives, endpoints (including primary and secondary endpoint sub-sections), and exploratory or tertiary endpoints, plus an objectives and endpoints summary.","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},161034,1790002220,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":76,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"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":140,"read_time":141},687197207057,"https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0","JRMO Clinical Investigation Plan (CIP) Template\nGeneral NOTE: Green text is template text or guidance and should be removed and replaced with trial specific text. Black text should not be altered or removed. Please insert “n/a” if a section is not applicable to your clinical investigation plan. This enables the Joint Research management Office (JRMO) team to see you have considered all sections. As part of the review these will be removed.\nThis CIP is written based on a UK based study- alterations can be made to specific words (REC to ethical committee for example) when used for a multi country studies.\nFull Title \t\u003Cfull title of study>\n\u003CChoose a descriptive study title that includes design (e.g. randomised, double-blind, placebo-controlled, etc.), the investigational device and intervention, and target disease(s). It should be immediately evident what the study is investigating and on whom to allow rapid judgment of relevance>\nShort Title\t\u003Cshort title of study>\n\u003CProvide a summary of the long title, using a short title or acronym. The short title is used on information sheets and consent forms for research participants. The short title should be sufficiently detailed to ensure it is clear to participants what the research is about in lay language>\n\u003CBefore choosing an acronym (instead of a short title), consider:\nWhether any studies already exist with the same acronym (search the internet and check with the JRMO).\nWhether the same acronym is used by regulators, finance, or governance teams.\nWhether the acronym could cause offence or be misinterpreted, particularly if the study is international.>\n\u003CFor follow-up studies it is discouraged to use the same titles (e.g. Banana and then Banana II) to ensure studies easily distinguished from other Research Ethics Committee (REC) approved studies, thereby avoiding administrative errors during the study management.>\n\u003CIf acronyms are used the full title should explain them. The proposed acronym should not drive the long title.>\nSponsor\t\u003CDelete as applicable>\nBarts Health NHS Trust\nOR\nQueen Mary University of London\nContact person:\nDr Mays Jawad\nGovernance Operations Manager\nJoint Research Management Office\nMile End Road\nLondon E1 4NS\nPhone: +44 (0) 20 7882 7275\nEmail: \u0013 HYPERLINK \"mailto:research.governance@qmul.ac.uk\" \u0014research.governance@qmul.ac.uk\u0015\nIRAS Number\t\u003CIRAS number>\nChief Investigator\t\u003CChief Investigator title and name >\n\u003CChief Investigator job title>\n\u003CChief Investigator postal address>\n\u003CChief Investigator telephone number>\n\u003CChief Investigator email address>\n\u000f\nStudy Contacts\n\u003CInclude phone, email, and fax numbers of all the key study contacts. Use shared/ study specific email addresses where possible>\n\u003CIt is acceptable to maintain the full list of investigators and sites separately. If you wish to do so, state the name and location of the investigator list here>\nList of laboratories\t\u003Cname of laboratory>\n\u003CName of head of laboratory>\n\u003CPostal address of laboratory>\n\u003CTelephone number of laboratory>\n\u003CEmail address of main contact at laboratory>\n\u003CREPEAT FOR EACH LABORATORY>\n\u003C\nList of central facilities\t\u003CName of central facility>\n\u003CName of head of central facility>\n\u003CPostal address of central facility>\n\u003CTelephone number of central facility>\n\u003CEmail address of main contact at central facility>\n\u003CREPEAT FOR EACH CENTRAL FACILITY>\n\u000fSummary of Changes\n\u000f\nContents\n\u0003Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc81994862\" \u0014I.\tContents\t\u0013 PAGEREF _Toc81994862 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc81994863\" \u0014II. Glossary of terms and abbreviations\t\u0013 PAGEREF _Toc81994863 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc81994864\" \u0014III. Signature page\t\u0013 PAGEREF _Toc81994864 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc81994865\" \u0014IV. Synopsis\t\u0013 PAGEREF _Toc81994865 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc81994866\" \u00141.0 Introduction\t\u0013 PAGEREF _Toc81994866 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc81994867\" \u00141.1 Background\t\u0013 PAGEREF _Toc81994867 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc81994868\" \u00141.2 Rationale for study design\t\u0013 PAGEREF _Toc81994868 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_To","cbCaioNksUX6vlVR","https://ap.wps.com/l/cbCaioNksUX6vlVR","docx",406629,66,"English","# Contents\n## Glossary of terms and abbreviations\n## Signature page\n## Synopsis\n## 1.0 Introduction\n## 2.0 Trial objectives\n## 2.6 Study design\n## 3.0 Patient Evaluability and Replacement\n## 4.0 Informed consent procedures\n## 5.0 Participant allocation\n## 6.0 Participant eligibility criteria","[{\"question\":\"What is the purpose of the JRMO Clinical Investigation Plan (CIP) template?\",\"answer\":\"It is a structured framework for documenting essential clinical investigation information, enabling consistent review and study management across required sections.\"},{\"question\":\"How should template guidance text be handled?\",\"answer\":\"Green template text is guidance and should be removed and replaced with trial-specific information; sections not applicable should use “n/a”.\"},{\"question\":\"What sections are included for trial objectives and outcomes?\",\"answer\":\"The template contains sections for primary and secondary objectives, endpoints (including primary and secondary endpoint sub-sections), and exploratory or tertiary endpoints, plus an objectives and endpoints summary.\"}]","JRMO Clinical Investigation Plan (CIP) Template - Clinical investigation plan structure template | DOCX",1788088446,23]