[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-209156-en":3,"doc-seo-209156-105":30,"detail-sidebar-cat-0-en-105":91},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":4,"category_id":11,"category_name":12,"doc_title":13,"doc_description":14,"doc_content":15,"file_id":16,"file_url":17,"file_type":18,"file_size":19,"view_count":4,"is_deleted":4,"is_public":20,"is_downloadable":20,"audit_status":20,"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":14,"update_tm":28,"read_time":29},209156,2336474459895,"Gloria","https://ap-avatar.wpscdn.com/avatar/22000baeef7a5ed0655?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786071322749376916",8,"Research & Report","Prospective Research Study Protocol Template - Can a Prescribed Walking Program with or without Monitoring Impact Dizziness in the Older Adults?","Prospective research study protocol template for evaluating whether a prescribed walking program, with or without monitoring, affects dizziness among older adults. The protocol identifies study sponsorship and principal investigator information and organizes key methodological elements, including objectives, study and research design, intervention description, recruitment and screening, consent procedures, randomization, and study visit schedules. It also specifies outcome measures, data management and quality plans, confidentiality and de-identification, sample size determination, statistical analysis, and a comprehensive risk/benefit and mitigation framework.","Prospective Research Study Protocol Template  \nStudy Protocol Title:  \n“Can A Prescribed Walking Program with or without Monitoring Impact Dizziness in the Older Adults?”  \nStudy Sponsor:  \nFlorida Hospital  \nPrincipal Investigator:  \nAmie Marie Jasper  \nCurrent Version Date: Previous Version Date: 11/30/2018  \n12/28/2018  \nIRBNet \\#: 1038487 Page 1 of 26  \nResearch Study protocol template version date 11/3/2016  \nList of Abbreviations: ..................................................................................................................... 4  \nIntroduction ..................................................................................................................................... 5  \nBackground Information and Scientific Rationale ......................................................................... 5  \nStudy Objectives ............................................................................................................................. 8  \nStudy Design ................................................................................................................................... 8  \nResearch Design.......................................................................................................................... 8  \nStudy Agent, Device, and/or Intervention Description ............................................................... 9  \nStudy Site(s)/Location(s) and Number of Subjects .................................................................... 9  \nMulti-Site Research Logistics/Communication Plan .................................................................. 9  \nResearch Conducted in a Foreign Country ............................................................................... 10  \nCommunity-Based Participatory Research ............................................................................... 10  \nSubject Selection ........................................................................................................................... 10  \nVulnerable Populations (if applicable) ..................................................................................... 10  \nInclusion Criteria ...................................................................................................................... 10  \nExclusion Criteria ..................................................................................................................... 10  \nResources Available ...................................................................................................................... 10  \nStudy Procedures .......................................................................................................................... 12  \nSubject Recruitment and Screening .......................................................................................... 12  \nConsent Process ........................................................................................................................ 12  \nDocumentation of Informed Consent Process .......................................................................... 12  \nRandomization .......................................................................................................................... 12  \nStudy Visits ............................................................................................................................... 14  \nStudy Duration .......................................................................................................................... 16  \nMaterials of Human Origin: Collection, Preparation, Handling and Shipping........................ 17  \nStudy Outcome Measures (Endpoints) ......................................................................................... 17  \nData Management and Quality Plan ............................................................................................. 18  \nData De-identification ..............................................","cbCailpXZL2LbUwy","https://ap.wps.com/l/cbCailpXZL2LbUwy","pdf",392515,1,29,"English","en",105,"# List of Abbreviations\n# Introduction\n## Background Information and Scientific Rationale\n## Study Objectives\n## Study Design\n## Research Design\n## Study Agent, Device, and/or Intervention Description\n## Study Site(s)/Location(s) and Number of Subjects\n## Multi-Site Research Logistics/Communication Plan\n## Research Conducted in a Foreign Country\n## Community-Based Participatory Research\n## Subject Selection\n## Vulnerable Populations (if applicable)\n## Inclusion Criteria\n## Exclusion Criteria\n## Resources Available\n# Study Procedures\n## Subject Recruitment and Screening\n## Consent Process\n## Documentation of Informed Consent Process\n## Randomization\n## Study Visits\n## Study Duration\n## Materials of Human Origin: Collection, Preparation, Handling and Shipping\n## Study Outcome Measures (Endpoints)\n## Data Management and Quality Plan\n## Data De-identification\n## Data Confidentiality, Storage, and Retention\n## Data Quality\n## Data Sharing (outside of Florida Hospital)\n## Sample Size Determination\n## Statistical Analysis Plan\n## Potential Risks and Benefits\n## Potential Benefits\n## Potential Risks\n## Mitigation of Risks\n## Provisions to Protect the Privacy Interest of Subjects\n## Early Withdrawal of Subjects\n## Investigator Withdrawal of Subjects\n## Subject Request for Withdrawal from Study","[{\"question\":\"What is the primary research question of this study protocol?\",\"answer\":\"Whether a prescribed walking program, with or without monitoring, impacts dizziness in older adults.\"},{\"question\":\"How does the protocol address participant recruitment and consent?\",\"answer\":\"It includes subject recruitment and screening steps, a consent process, and documentation of the informed consent procedures.\"},{\"question\":\"What major elements cover study execution and data handling?\",\"answer\":\"The protocol specifies research design, intervention details, randomization, study visits and duration, outcome measures, and data management including de-identification, confidentiality, storage/retention, and data quality.\"}]","Prospective Research Study Protocol Template - Can a Prescribed Walking Program with or without Monitoring Impact Dizziness in the Older Adults? | 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