[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-164469-105":53,"doc-detail-164469-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","clinical-monitoring-plan-template-tool-summary-sheet","Clinical Monitoring Plan Template - Tool Summary Sheet","","A Word-based tool summary sheet that provides a starting point for preparing a Clinical Monitoring Plan. It defines the intended audience of Clinical Research Associates and supplies an outline, draft language, and best-practice guidance for customizing the plan to monitoring-group needs. It emphasizes clear communication between the monitoring group and any Data Coordinating Center, standardizes terminology using CROMS, and instructs proper replacement of placeholders, deletion of template instructional text, and retention of version information. It also includes signatory blocks and a structured table-of-contents framework for monitoring activities and reports.",{"@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/clinical-monitoring-plan-template-tool-summary-sheet/164469/",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/clinical-monitoring-plan-template-tool-summary-sheet/164469.png","ImageObject",442,249,{"name":88,"@type":89},"Levi","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-23","2026-08-31",true,{"@type":98,"interactionType":99,"userInteractionCount":79},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"Who should use this Clinical Monitoring Plan template?","Question",{"text":108,"@type":109},"Clinical Research Associates responsible for preparing a Clinical Monitoring Plan should use it.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What should be customized before using the draft template?",{"text":113,"@type":109},"Review the draft template and customize it to the monitoring group’s specific needs and requirements. Update sample text as needed and ensure communication with any Data Coordinating Center is clearly outlined.",{"name":115,"@type":106,"acceptedAnswer":116},"How are placeholders and instructional text handled in the template?",{"text":117,"@type":109},"Replace placeholders like \u003Cprotocol title> with study-specific details, and delete template-specific instructional text and the Tool Summary Sheet during the monitoring plan development process. Instructional text is indicated by special styles and brace-enclosed guidance for accessibility.","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},164469,1788153752,{"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":79,"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":125,"read_time":140},7971461740909,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Tool Summary Sheet: \u000bClinical Monitoring Plan Template\nPurpose: MS Word template to be used as a starting point for preparing a Clinical Monitoring Plan.\nAudience/User\nClinical Research Associates responsible for preparing a Clinical Monitoring Plan\nDetails\nThis template includes a proposed structure for a Clinical Monitoring Plan as well as draft language and other guidance.\nBest Practice Recommendations\nReview this draft template and customize to the specific needs and requirements of the monitoring group.  Sample text may be updated as needed.\nIf the study is utilizing a Data Coordinating Center (DCC), ensure that communication and interaction between the monitoring group and the DCC is clearly outlined in pertinent sections.\n“CROMS” is used as the monitoring group throughout this template.  Replace with monitoring entity as applicable.\nTechnical/Formatting Notes\nInstructions and explanatory text are indicated by {blue italics} (“CROMS_Instruction” style).  Instructional text will also be enclosed in braces to signify this text for screen-readers used by the visually impaired.\nText enclosed with \u003C> is a placeholder for a specific detail (e.g., \u003Cprotocol title>); replace as appropriate.\nDelete template-specific {instructional text} as well as this Tool Summary Sheet during the monitoring plan development process.\nLeave the template version information in the lower left hand corner of the document. Add “Based on” in front of “Template Version” of desired.\nIt is easiest and cleanest to use the styles that are embedded in the document.  (In MS Word 2007: From the Home menu, select the bottom right arrow key to bring up the styles box, select “Options”, under “Select Styles to Show” select “in current document”.)\nEnsure that a placeholder and example text is replaced with the study-specific information.\nTool Revision History:\n\u000f\nClinical Research Operations and Management Support\nClinical Monitoring Plan\nProtocol Number \u003Cprotocol number>\n\u003Cprotocol title>\nBy signing below, I acknowledge my agreement to this plan.\nOCTOM Representative\nName:  _______________________________________\nSignature:  ___________________________________\tDate:  __________\nStudy Representative\nName:  _______________________________________\nSignature:  ___________________________________\tDate:  __________\n\u000f\nTable of Contents\n{This table uses the Table of Contents function in Microsoft Word that will automatically update headings and page numbers used in the body of the report.  In the body of the report, add, delete, or modify headings as needed in order to best reflect your study.}\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc501446823\" \u00141.0\tLIST OF ABBREVIATIONS\t\u0013 PAGEREF _Toc501446823 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446824\" \u00142.0\tINTRODUCTION\t\u0013 PAGEREF _Toc501446824 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446825\" \u00143.0\tMONITORING COMMUNICATION PLAN\t\u0013 PAGEREF _Toc501446825 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446826\" \u00143.1\tEmail Distribution\t\u0013 PAGEREF _Toc501446826 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446827\" \u00143.2\tWebsite Distribution\t\u0013 PAGEREF _Toc501446827 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446828\" \u00143.2.1\tFinal Visit Reports\t\u0013 PAGEREF _Toc501446828 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446829\" \u00143.2.2\tOther Monitoring Communications\t\u0013 PAGEREF _Toc501446829 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446830\" \u00144.0\tVISIT SCHEDULING\t\u0013 PAGEREF _Toc501446830 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446831\" \u00145.0\tESSENTIAL DOCUMENTS/TRIAL MASTER FILE\t\u0013 PAGEREF _Toc501446831 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446832\" \u00145.1\tRequired Essential Documents\t\u0013 PAGEREF _Toc501446832 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446833\" \u00145.2\tTrial Master File (TMF)\t\u0013 PAGEREF _Toc501446833 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446834\" \u00145.3\tMonitor’s Role in Essential Document Maintenance\t\u0013 PAGEREF _Toc501446834 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446835\" \u00146.0\tMONITORING REPORTS / ACTION ITEMS\t\u0013 PAGEREF _Toc501446835 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446836\" \u00147.0\tTYPES OF VISITS AND MONITORING ACTIVITIES\t\u0013 PAGEREF _Toc501446836 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc501446837","cbCaipJBao4WMuFN","https://ap.wps.com/l/cbCaipJBao4WMuFN","docx",91918,25,"English","# Purpose\n# Audience/User\n## Details\n## Best Practice Recommendations\n# Technical/Formatting Notes\n## Placeholder and instructional text handling\n# Clinical Monitoring Plan\n## Protocol number and title\n# Signatures\n# List of Abbreviations\n## Key acronyms\n# Table of Contents\n## Introduction\n## Monitoring Communication Plan\n## Visit Scheduling\n## Essential Documents/Trial Master File\n## Monitoring Reports/Action Items\n## Types of Visits and Monitoring Activities","[{\"question\":\"Who should use this Clinical Monitoring Plan template?\",\"answer\":\"Clinical Research Associates responsible for preparing a Clinical Monitoring Plan should use it.\"},{\"question\":\"What should be customized before using the draft template?\",\"answer\":\"Review the draft template and customize it to the monitoring group’s specific needs and requirements. Update sample text as needed and ensure communication with any Data Coordinating Center is clearly outlined.\"},{\"question\":\"How are placeholders and instructional text handled in the template?\",\"answer\":\"Replace placeholders like \\u003cprotocol title\\u003e with study-specific details, and delete template-specific instructional text and the Tool Summary Sheet during the monitoring plan development process. Instructional text is indicated by special styles and brace-enclosed guidance for accessibility.\"}]","Clinical Monitoring Plan Template - Tool Summary Sheet | DOCX",9]