[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-165016-en":3,"doc-seo-165016-105":30,"detail-sidebar-cat-1-en-105":92},{"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},165016,5909877438554,"Maeve","https://ap-avatar.wpscdn.com/avatar/5600025385ad2bf12a7?_k=1778553567797529272",1,11,"Presentations","Protocol Synopsis - Medical Monitor Oversight Report for Clinical Studies","A Microsoft Word template for preparing the NIDCR Medical Monitor Oversight Report for clinical studies. It provides a recommended report structure, draft language, and guidance for statisticians and principal investigators, including how to use embedded styles, replace placeholders like protocol fields, and remove template-specific instructional text. It also outlines submission via CROMS for Medical Monitor review and describes key report sections covering objectives, enrollment status, participant status, outcomes, biospecimens, safety reporting, and quality management findings, with appendix options for tables, figures, and listings.","Tool Summary Sheet:\nNIDCR Medical Monitor Oversight Report Template\nPurpose: MS Word template to be used as a starting point for preparing an oversight report for Medical Monitor review\nAudience/User\nStatisticians and/or Principal Investigators responsible for preparing NIDCR Oversight Reports for Medical Monitor review\nDetails\nThis template includes a proposed structure for the oversight report as well as draft language and other guidance.\nCompleted reports should be submitted to NIDCR via CROMS by email at \u0013 HYPERLINK \"mailto:NIDCR_Reports@rhoworld.com\" \u0014NIDCR_Reports@rhoworld.com\u0015.\nBest Practice Recommendations\nReview this template several months prior to the first report due date, and customize to the specific needs and requirements of the study.\nIn the template, the instructions 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 report development process.\nLeave the template version information in the lower left hand corner of the document.\nIt is easiest and cleanest to use the styles that are embedded in the document, rather than to create your own.\nEnsure that all placeholder and example text is replaced with the study specific information.\nIf you have questions regarding how your study should be presented in this template, please contact your Program Official, Medical Monitor, or OCTOM.\nSubmit your finalized report to NIDCR via CROMS by email at \u0013 HYPERLINK \"mailto:NIDCR_Reports@rhoworld.com\" \u0014NIDCR_Reports@rhoworld.com\u0015.  CROMS will provide the report to the NIDCR Medical Monitor for review and advise your Program Official and OCTOM of its status.\nTool Revision History:\nNIDCR medical Monitor OVERSIGHT Report\nFOR CLINICAL STUDIES\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 \"_Toc482801010\" \u0014Protocol Synopsis\t\u0013 PAGEREF _Toc482801010 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801011\" \u0014Executive Summary\t\u0013 PAGEREF _Toc482801011 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801012\" \u00141.0\tReport Overview\t\u0013 PAGEREF _Toc482801012 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801013\" \u00142.0\tStudy Objectives and Timeline\t\u0013 PAGEREF _Toc482801013 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801014\" \u00143.0\tEnrollment and Retention Status\t\u0013 PAGEREF _Toc482801014 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801015\" \u00144.0\tParticipant Status\t\u0013 PAGEREF _Toc482801015 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801016\" \u00145.0\tStatus of Outcome Measures\t\u0013 PAGEREF _Toc482801016 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801017\" \u00146.0\tBiospecimen Status\t\u0013 PAGEREF _Toc482801017 \\h \u001413\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801018\" \u00147.0\tSafety Management and Reporting\t\u0013 PAGEREF _Toc482801018 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801019\" \u00147.1\tUnanticipated Problems\t\u0013 PAGEREF _Toc482801019 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801020\" \u00147.2\tSerious Adverse Events\t\u0013 PAGEREF _Toc482801020 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801021\" \u00147.3\tAdverse Events\t\u0013 PAGEREF _Toc482801021 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801022\" \u00147.4\tProtocol Deviations\t\u0013 PAGEREF _Toc482801022 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801023\" \u00148.0\tQuality Management / Monitoring Findings\t\u0013 PAGEREF _Toc482801023 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801024\" \u00149.0\tStudy Challenges and Solutions\t\u0013 PAGEREF _Toc482801024 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801025\" \u0014Appendix A: Additional Summary Tables\t\u0013 PAGEREF _Toc482801025 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801026\" \u0014Appendix B: Additional Figures\t\u0013 PAGEREF _Toc482801026 \\h \u001418\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc482801027\" \u0014Appendix C: Additional Data Listings\t\u0013 PAGEREF _Toc482801","cbCaikFeeUtQE8sV","https://ap.wps.com/l/cbCaikFeeUtQE8sV","docx",295219,19,"English","en",105,"# Table of Contents\n## Executive Summary\n## 1.0 Report Overview\n## 2.0 Study Objectives and Timeline\n## 3.0 Enrollment and Retention Status\n## 4.0 Participant Status\n## 5.0 Status of Outcome Measures\n## 6.0 Biospecimen Status\n## 7.0 Safety Management and Reporting\n## 7.1 Unanticipated Problems\n## 7.2 Serious Adverse Events\n## 7.3 Adverse Events\n## 7.4 Protocol Deviations\n## 8.0 Quality Management / Monitoring Findings\n## 9.0 Study Challenges and Solutions\n## Appendix A: Additional Summary Tables\n## Appendix B: Additional Figures\n## Appendix C: Additional Data Listings","[{\"question\":\"Who is the intended audience for the NIDCR Medical Monitor Oversight Report template?\",\"answer\":\"Statisticians and/or principal investigators responsible for preparing NIDCR Oversight Reports for Medical Monitor review.\"},{\"question\":\"What should be customized in the template before submission?\",\"answer\":\"Replace all placeholders and example text with study-specific information, and remove template-specific instructional text and this tool summary sheet during report development.\"},{\"question\":\"How are completed reports submitted for Medical Monitor review?\",\"answer\":\"Submit the finalized report to NIDCR via CROMS by email at NIDCR_Reports@rhoworld.com. CROMS provides the report to the NIDCR Medical Monitor and advises the program official and OCTOM of its status.\"}]","Protocol Synopsis - Medical Monitor Oversight Report for Clinical Studies | DOCX",1788164630,7,{"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":87,"head_meta":89,"extra_data":91,"updated_unix":28},"protocol-synopsis-medical-monitor-oversight-report-for-clinical-studies","",{"@graph":36,"@context":86},[37,54,69],{"@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/presentations/",3,{"item":52,"name":14,"@type":43,"position":53},"https://docshare.wps.com/template/protocol-synopsis-medical-monitor-oversight-report-for-clinical-studies/165016/",4,{"url":52,"name":14,"@type":55,"author":56,"headline":14,"publisher":58,"fileFormat":61,"inLanguage":23,"description":15,"dateModified":62,"datePublished":63,"encodingFormat":61,"isAccessibleForFree":64,"interactionStatistic":65},"DigitalDocument",{"name":9,"@type":57},"Person",{"url":41,"name":59,"@type":60},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-05","2026-08-31",true,{"@type":66,"interactionType":67,"userInteractionCount":29},"InteractionCounter",{"@type":68},"ViewAction",{"@type":70,"mainEntity":71},"FAQPage",[72,78,82],{"name":73,"@type":74,"acceptedAnswer":75},"Who is the intended audience for the NIDCR Medical Monitor Oversight Report template?","Question",{"text":76,"@type":77},"Statisticians and/or principal investigators responsible for preparing NIDCR Oversight Reports for Medical Monitor review.","Answer",{"name":79,"@type":74,"acceptedAnswer":80},"What should be customized in the template before submission?",{"text":81,"@type":77},"Replace all placeholders and example text with study-specific information, and remove template-specific instructional text and this tool summary sheet during report development.",{"name":83,"@type":74,"acceptedAnswer":84},"How are completed reports submitted for Medical Monitor review?",{"text":85,"@type":77},"Submit the finalized report to NIDCR via CROMS by email at NIDCR_Reports@rhoworld.com. CROMS provides the report to the NIDCR Medical Monitor and advises the program official and OCTOM of its status.","https://schema.org",{"og:url":52,"og:type":88,"og:title":14,"og:site_name":59,"og:description":15},"article",{"robots":90,"canonical":52},"index,follow",{"doc_id":7,"site_id":24},{"code":4,"msg":5,"data":93},[94,97,102,107,112,117,122,127,132],{"id":12,"doc_module":11,"doc_module_name":46,"category_name":13,"show_sort_weight":95,"slug":96},90,"presentations",{"id":98,"doc_module":11,"doc_module_name":46,"category_name":99,"show_sort_weight":100,"slug":101},12,"Resumes",80,"resumes",{"id":103,"doc_module":11,"doc_module_name":46,"category_name":104,"show_sort_weight":105,"slug":106},14,"Invoices",70,"invoices",{"id":108,"doc_module":11,"doc_module_name":46,"category_name":109,"show_sort_weight":110,"slug":111},15,"Posters",60,"posters",{"id":113,"doc_module":11,"doc_module_name":46,"category_name":114,"show_sort_weight":115,"slug":116},16,"Social Media",50,"social-media",{"id":118,"doc_module":11,"doc_module_name":46,"category_name":119,"show_sort_weight":120,"slug":121},17,"Forms",40,"forms",{"id":123,"doc_module":11,"doc_module_name":46,"category_name":124,"show_sort_weight":125,"slug":126},18,"Letters",30,"letters",{"id":128,"doc_module":11,"doc_module_name":46,"category_name":129,"show_sort_weight":130,"slug":131},21,"Paper Templates",5,"papers-templates",{"id":133,"doc_module":11,"doc_module_name":46,"category_name":134,"show_sort_weight":4,"slug":135},158,"General","general-158"]