[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-161446-105":53,"doc-detail-161446-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","nimh-clinical-monitoring-plan-cmp-template-clinical-monitoring-structure-guidance","NIMH Clinical Monitoring Plan (CMP) Template - Clinical Monitoring Structure Guidance","","NIMH Clinical Monitoring Plan (CMP) Template provides a recommended, adaptable structure and draft language for developing a clinical monitoring plan. It guides Clinical Research Associates or Principal Investigators on what to include, how to distinguish instruction text from editable example content, and how to update version numbers and dates in page headers. The template also includes a principal investigator acknowledgement and signature sheet and a comprehensive outline covering introduction, site contact information, visit scheduling, monitoring activities, reports, essential documents, deviations, SAE reporting, and site management.",{"@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":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/nimh-clinical-monitoring-plan-cmp-template-clinical-monitoring-structure-guidance/161446/",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/nimh-clinical-monitoring-plan-cmp-template-clinical-monitoring-structure-guidance/161446.png","ImageObject",442,249,{"name":88,"@type":89},"Gelato","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-29","2026-08-30",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",6,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"Who is the intended audience for the CMP template?","Question",{"text":109,"@type":110},"The template is intended for Clinical Research Associates (CRAs) or Principal Investigators (PIs) responsible for preparing the Clinical Monitoring Plan.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"How should instructional text and example text be handled?",{"text":114,"@type":110},"Instruction or explanatory text indicated in italics should be deleted, including any footnotes to that instructional text. Example text in brackets can be incorporated as written or modified to fit the study intervention and trial design, or deleted if not appropriate.",{"name":116,"@type":107,"acceptedAnswer":117},"What sections are covered in the Clinical Monitoring Plan structure?",{"text":118,"@type":110},"The outline includes introduction, study contact information, visit scheduling, monitoring activities (including initiation, interim, for-cause, and close-out visits), monitoring reports and action items, essential documents and TMF, source document verification, protocol deviations, SAE reporting, report writing, and site management/correspondence.","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},161446,1788099843,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":8,"category_name":11,"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":126,"read_time":141},19241457091524,"https://us-avatar.wpscdn.com/davatar_276721f389ce27ea32af1340a28f341c","NIMH Clinical Monitoring Plan (CMP) Template\nTool Summary (Remove Tool Summary before finalizing and distributing the document)\nPurpose: This template provides a recommended structure for a Clinical Monitoring Plan (CMP), as well as draft language and other guidance. It is to be used as a starting point for preparing a Clinical Monitoring Plan.\nAudience/User: Clinical Research Associates (CRAs) or Principal Investigators (PI) responsible for preparing a Clinical Monitoring Plan.\nHow to Use This Template\nThis template contains two types of text: instruction/explanatory and example text.  Instruction/ explanatory text are indicated by italics and should deleted. Footnotes to instructional text should also be deleted. This text provides information on the content that should be included. Example text is included to further aid in document development and should either be modified to suit the drug, biologic or device (study intervention), design, and conduct of the planned clinical trial or deleted. Example text is indicated in [brackets with regular font]. Within example text, a need for insertion of specific information is notated by \u003Cangle brackets>. Example text can be incorporated as written or tailored to a particular document. If it is not appropriate to the document, however, it too should be deleted.\nVersion control is important to track document development, revisions, and amendments. It is also necessary to ensure that the correct version of this document is used by all staff conducting the study. With each revision, the version number and date located in the header of each page should be updated.\nCLINICAL MONITORING PLAN ACKNOWLEDGEMENT AND SIGNATURE SHEET\nPrincipal Investigator: \u003CInvestigator name>\nFunding: National Institutes of Health/ National Institute of Mental Health (NIH/NIMH)\nInvestigational Intervention: \u003CIntervention name>\nProtocol Number: \u003CProtocol number>\nProtocol Title: \u003CProtocol Title>\nBy signing below, I acknowledge my agreement to this plan.\nSignature: _________________________\t\tDate: _______________\nPrincipal Investigator \u003CName, MD/PhD>\nCLINICAL MONITORING PLAN\nPrincipal Investigator: \u003CInvestigator name>\nFunding: National Institutes of Health/ National Institute of Mental Health (NIH/NIMH)\nInvestigational Intervention: \u003CIntervention name>\nProtocol Number: \u003CProtocol number>\nProtocol Title: \u003CProtocol title>\nPrepared by: \t\u003CName>\n\u003CTitle>\n\u003CCompany/Affiliation>\nSignature: _________________________\t\tDate: _______________\nClinical Monitoring Plan Revision History:\n\u000f\nTable of Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc468458014\" \u00141.0\tLIST OF ABBREVIATIONS\t\u0013 PAGEREF _Toc468458014 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458015\" \u00142.0\tINTRODUCTION\t\u0013 PAGEREF _Toc468458015 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458016\" \u00143.0\tSTUDY CONTACT INFORMATION\t\u0013 PAGEREF _Toc468458016 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458017\" \u00144.0\tVISIT SCHEDULING\t\u0013 PAGEREF _Toc468458017 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458018\" \u00144.1\tType of Visit\t\u0013 PAGEREF _Toc468458018 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458019\" \u00144.2\tStudy Monitoring Schedule\t\u0013 PAGEREF _Toc468458019 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458020\" \u00145.0\tMONITORING ACTIVITIES\t\u0013 PAGEREF _Toc468458020 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458021\" \u00145.1\tSite Initiation Visit\t\u0013 PAGEREF _Toc468458021 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458022\" \u00145.1.1\tSIV Preparation\t\u0013 PAGEREF _Toc468458022 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458023\" \u00145.1.2\tSIV On-Site Activities\t\u0013 PAGEREF _Toc468458023 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458024\" \u00145.2\tInterim Monitoring Visit Activities\t\u0013 PAGEREF _Toc468458024 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458025\" \u00145.2.1\tIMV Preparation Activities\t\u0013 PAGEREF _Toc468458025 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458026\" \u00145.2.2\tIMV On-site Activities\t\u0013 PAGEREF _Toc468458026 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458027\" \u00145.3\tFor-cause Visit Activities\t\u0013 PAGEREF _Toc468458027 \\h \u001418\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458028\" \u00145.4\tClose-out Visit Activities\t\u0013 PAGEREF _Toc468458028 \\h \u001418\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc468458029\" \u00145.4.1\tCOV Preparati","cbCaisvzySUElwyt","https://ap.wps.com/l/cbCaisvzySUElwyt","docx",82454,28,"English","# List of Abbreviations\n# Introduction\n# Study Contact Information\n# Visit Scheduling\n## Type of Visit\n## Study Monitoring Schedule\n# Monitoring Activities\n## Site Initiation Visit\n## Interim Monitoring Visit Activities\n## For-cause Visit Activities\n## Close-out Visit Activities\n# Monitoring Reports / Action Items\n# Essential Documents / Trial Master File\n# Source Document Verification\n# Protocol Deviations\n# Serious Adverse Event (SAE) Reporting\n# Report Writing\n# Site Management and Correspondence","[{\"question\":\"Who is the intended audience for the CMP template?\",\"answer\":\"The template is intended for Clinical Research Associates (CRAs) or Principal Investigators (PIs) responsible for preparing the Clinical Monitoring Plan.\"},{\"question\":\"How should instructional text and example text be handled?\",\"answer\":\"Instruction or explanatory text indicated in italics should be deleted, including any footnotes to that instructional text. Example text in brackets can be incorporated as written or modified to fit the study intervention and trial design, or deleted if not appropriate.\"},{\"question\":\"What sections are covered in the Clinical Monitoring Plan structure?\",\"answer\":\"The outline includes introduction, study contact information, visit scheduling, monitoring activities (including initiation, interim, for-cause, and close-out visits), monitoring reports and action items, essential documents and TMF, source document verification, protocol deviations, SAE reporting, report writing, and site management/correspondence.\"}]","NIMH Clinical Monitoring Plan (CMP) Template - Clinical Monitoring Structure Guidance | DOCX",10]