[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-392424-105":53,"doc-detail-392424-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-interventional-study-protocol-template-version-6-protocol-version-details","Clinical Interventional Study Protocol Template - Version 6 - Protocol version details","","Clinical Interventional Study Protocol Template provides a suggested structure for clinical trials sponsored by the National Institute on Aging (NIA), including single- and multi-center intervention studies such as drug, surgery, behavioral, nutritional, and device trials. It explains how to replace italicized instructional text with study-specific content, where to include headings in regular type, and how to summarize changes when moving from an approved final protocol. The template includes guidance for version and date placement and outlines a dementia caregiver study table of contents with key protocol sections.",{"@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-interventional-study-protocol-template-version-6-protocol-version-details/392424/",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-interventional-study-protocol-template-version-6-protocol-version-details/392424.png","ImageObject",442,249,{"name":88,"@type":89},"Liam","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-04","2026-09-25",true,{"@type":98,"interactionType":99,"userInteractionCount":73},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the purpose of the Clinical Interventional Study Protocol Template?","Question",{"text":108,"@type":109},"It provides a general protocol format for NIA-sponsored clinical trials, including single- and multi-center clinical intervention studies across multiple intervention types.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What should be replaced in the protocol when using the template?",{"text":113,"@type":109},"Italicized instructions and explanatory text should be replaced with appropriate study-specific content, while section headings and regular-type template text should be included as provided.",{"name":115,"@type":106,"acceptedAnswer":116},"Where are the version number and date indicated, and how should changes be handled?",{"text":117,"@type":109},"The version number and date are listed at the bottom of each page, and when changes are made to an approved final protocol, a summary of changes with the date should be provided at the front.","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},392424,1791145824,{"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":73,"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":20},8796095461564,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Clinical Interventional Study Protocol Template  \nPREFACE  \nThe Clinical Intervention Study Protocol Template is a suggested format for clinical trials sponsored by the National Institute on Aging (NIA). Investigators are encouraged to use this format, as appropriate, when developing protocols for their studies. Large multi-site observational studies will also benefit from this protocol template.  \nNote that instructions and explanatory text are indicated by italics and should be replaced in your protocol with appropriate text. Section headings and template text formatted in regular type should be included in your protocol document as provided in the template.  \nThe goal of this template is to provide a general format applicable to all single-and multicenter clinical intervention trials (e.g., drug, surgery, behavioral, nutritional, device, etc).  \nAs you can see the version number and date are on the bottom of each page. When making changes to an approved and “final”protocol, please provide a summary of the changes, with the date, at the front of the protocol.  \nVIRTUAL TRAINING FOR LATINO CAREGIVERS TO MANAGE SYMPTOMS OF DEMENTIA  \nStudy Chairman or Principal Investigator: Magaly Ramirez, PhD, MS, MS, Assistant Professor, University of Washington School of Public Health,  \nDepartment of Health Services  \nSupported by:  \nThe National Institute on Aging  \nStudy Intervention Provided by: N/A  \nSponsor ofIND/IDE: N/A  \nVersion 6  \nSeptember 21, 2023  \nTABLE OF CONTENTS PAGE  \nPREFACE....................................................................................................................................... i  \nVIRTUAL Training for Latino Caregivers to Manage Symptoms of Dementia .................... ii  \nTABLE OF CONTENTS ............................................................................................................. ii  \nPRÉCIS......................................................................................................................................... iv  \nStudy Title .................................................................................................................................. iv  \nObjectives .................................................................................................................................. iv  \nDesign and Outcomes ................................................................................................................ iv  \nInterventions and Duration ......................................................................................................... v  \nSample Size and Population ........................................................................................................ v  \nSTUDY TEAM ROSTER............................................................................................................. 1  \nPrincipal Investigator: Magaly Ramirez, PhD, MS, MS.......................................................... 1  \nCo-Investigator: Robert Penfold, PhD .................................................................................... 1  \nResearch Coordinator: Celeste Garcia, CHES ......................................................................... 1  \nResearch Assistant: JP Lopez Garcia ……...………………………………………………..2  \nPARTICIPATING STUDY SITES ............................................................................................. 2  \nStudy Site Investigator: Magaly Ramirez, PhD, MS, MS........................................................ 2  \n1 Study objectives..................................................................................................................... 3  \n1.1 Primary Objective ........................................................................................................... 3  \n1.2 Secondary Objectives ...................................................................................................... 3  \n2 BACKGROUND AND RATIONALE ...........................................","cbCaitdqEsdUvngP","https://ap.wps.com/l/cbCaitdqEsdUvngP","pdf",999659,41,"English","# PREFACE\n## VIRTUAL Training for Latino Caregivers to Manage Symptoms of Dementia\n# TABLE OF CONTENTS\n## PRÉCIS\n## STUDY TEAM ROSTER\n## PARTICIPATING STUDY SITES\n# 1 Study objectives\n## 1.1 Primary Objective\n## 1.2 Secondary Objectives\n# 2 BACKGROUND AND RATIONALE\n## 2.1 Background on Condition, Disease, or Other Primary Study Focus\n## 2.2 Study Rationale\n# 3 STUDY DESIGN\n# 4 SELECTION AND ENROLLMENT OF PARTICIPANTS\n## 4.1 Inclusion Criteria\n## 4.2 Exclusion Criteria\n## 4.3 Study Enrollment Procedures\n# 5 STUDY INTERVENTIONS\n## 5.1 Interventions, Administration, and Duration\n## 5.2 Handling of Study Interventions\n## 5.3 Concomitant Interventions\n## 5.4 Adherence Assessment\n# 6 STUDY PROCEDURES\n## 6.1 Schedule of Evaluations\n## 6.2 Description of Evaluations","[{\"question\":\"What is the purpose of the Clinical Interventional Study Protocol Template?\",\"answer\":\"It provides a general protocol format for NIA-sponsored clinical trials, including single- and multi-center clinical intervention studies across multiple intervention types.\"},{\"question\":\"What should be replaced in the protocol when using the template?\",\"answer\":\"Italicized instructions and explanatory text should be replaced with appropriate study-specific content, while section headings and regular-type template text should be included as provided.\"},{\"question\":\"Where are the version number and date indicated, and how should changes be handled?\",\"answer\":\"The version number and date are listed at the bottom of each page, and when changes are made to an approved final protocol, a summary of changes with the date should be provided at the front.\"}]","Clinical Interventional Study Protocol Template - Version 6 - Protocol version details | PDF",1790369503]