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These types of studies require an expanded protocol with additional detail such as dosing, reporting of adverse events, etc.\nThis template is applicable to most studies, including observational studies, pre/post-intervention studies, case/control studies, biological sample collection, qualitative studies, cross-sectional studies, and studies that randomized into standard of care treatment.\nThe purpose of this protocol template is to assist you in addressing all aspects of study design. Not all of the questions listed below may apply to your specific study. Skip the ones that are not applicable.\nInstructions and examples are listed in each section of the protocol in red.\nThe goal of a protocol is to provide enough detail that anyone can read your protocol and duplicate your study. If your protocol is written appropriately, you should be able to copy/paste into the background and methods section of a manuscript without having to add additional details.\n\u000f\n\u003CPROJECT TITLE>\n\u003CDate>\nPRINCIPAL INVESTIGATOR:\nDEPARTMENT:\nINSTITUTION:\nPHONE:\nEMAIL:\nCO-INVESTIGATOR:\tCO-INVESTIGATOR:\nDEPARTMENT:\tDEPARTMENT:\nINSTITUTION:\tINSTITUTION:\nPHONE:\tPHONE:\nEMAIL:\tEMAIL:\nCO-INVESTIGATOR:\tCO-INVESTIGATOR:\nDEPARTMENT:\tDEPARTMENT:\nINSTITUTION:\tINSTITUTION:\nPHONE:\tPHONE:\nEMAIL:\tEMAIL:\nSTUDY COORDINATOR:\tRESEARCH ASSISTANT:\nDEPARTMENT:\tDEPARTMENT:\nINSTITUTION:\tINSTITUTION:\nPHONE:\tPHONE:\nEMAIL:\tEMAIL:\n\u000f\nTable of Contents\n\u0013 HYPERLINK \\l \"_Background/Introduction\" \u0014Background/Introduction\u0015\n\u0013 HYPERLINK \\l \"_Research_Question\" \u0014Research Question\u0015\n\u0013 HYPERLINK \\l \"_Primary_and_Secondary\" \u0014Primary and Secondary Aims\u0015\n\u0013 HYPERLINK \\l \"_Outcome_Definitions/Data_Points\" \u0014Outcome Definitions/Data Points Collected\u0015\n\u0013 HYPERLINK \\l \"_Study_Design\" \u0014Study Design\u0015\n\u0013 HYPERLINK \\l \"_Target_Population\" \u0014Target Population\u0015\n\u0013 HYPERLINK \\l \"_Inclusion/Exclusion_Criteria\" \u0014Inclusion and Exclusion Criteria\u0015\n\u0013 HYPERLINK \\l \"_Sampling_Method/Recruitment_Process\" \u0014Sampling Method and Recruitment Process\u0015\n\u0013 HYPERLINK \\l \"_Study_Retention/Withdrawal\" \u0014Study Retention and Withdrawal\u0015\n\u0013 HYPERLINK \\l \"_Study_Procedures\" \u0014Study Procedures\u0015\n\u0013 HYPERLINK \\l \"_Sample_Size_Justification\" \u0014Sample Size Justification\u0015\n\u0013 HYPERLINK \\l \"_Feasibility,_Accrual,_and\" \u0014Feasibility, Accrual, and Duration of Accrual\u0015\n\u0013 HYPERLINK \\l \"_Study_Limitations\" \u0014Study Limitations\u0015\n\u0013 HYPERLINK \\l \"_Administrative_Organization/Roles_a\" \u0014Data Analysis\u0015\n\u0013 HYPERLINK \\l \"_Administrative_Organization/Roles_a\" \u0014Administrative Organization, Roles and Responsibilities\u0015\n\u0013 HYPERLINK \\l \"_Use_of_Study\" \u0014Use of Study Results\u0015\n\u0013 HYPERLINK \\l \"_Study_budget\" \u0014Study Budget\u0015\n\u0013 HYPERLINK \\l \"_References_Cited\" \u0014References\u0015\n\u0013 HYPERLINK \\l \"_Appendices\" \u0014Appendices\u0015\n\u000fBackground/Introduction\nThis section should resemble the introduction/background section to a manuscript. Areas you should address:\nHas this subject matter been previously published, and if so, at what evidence level (i.e. what was the study design and sample size? Single or multiple center?) Include citations;\nGiven current knowledge on the subject, how will the proposed study add to the literature (i.e. what is the knowledge gap and how will this study fill it?);\nWhat is the potential impact of the proposed study (i.e. how will it change current practice?).\nIf you’ve collected preliminary data, provide details and results.\nResearch Question\nWhat is the question this study will be answering? Be very specific with your language, as this question will guide the rest of the language used in your study.\nPrimary and Secondary Aims\nGiven the study question, provide your primary aim (may be the same as the study question) and secondary aims if applicable. Provide hypotheses for any aims which involve a comparison between two or more groups.\nOutcome Definitions/Data Points Collected\nDefine all of your ","cbCaibJNRvMPBEwW","https://ap.wps.com/l/cbCaibJNRvMPBEwW","docx",36100,7,"English","# Background/Introduction\n# Research Question\n# Primary and Secondary Aims\n# Outcome Definitions/Data Points Collected\n# Study Design\n# Target Population\n# Inclusion and Exclusion Criteria\n# Sampling Method/Recruitment Process\n# Study Retention and Withdrawal\n# Study Procedures\n# Sample Size Justification\n# Feasibility, Accrual, and Duration of Accrual\n# Study Limitations\n# Data Analysis\n# Administrative Organization, Roles and Responsibilities\n# Use of Study Results\n# Study Budget\n# References\n# Appendices","[{\"question\":\"该协议模板适用于哪些研究类型？\",\"answer\":\"模板适用于不涉及新研究性药物或器械、且不需要随机临床试验扩展方案的研究。包括观察性研究、前/后干预研究、病例/对照研究、生物样本采集、定性研究、横断面研究，以及随机分配至标准治疗的研究。\"},{\"question\":\"撰写研究问题时需要注意什么？\",\"answer\":\"研究问题需要使用尽可能具体的表述，因为它将指导研究中其余部分的写法与用语选择。\"},{\"question\":\"模板中“结局定义/数据点收集”部分的要求是什么？\",\"answer\":\"需要明确所有将报告和/或比较的结局，并尽量具体。有时也可以用表格形式呈现以提高清晰度。\"}]","ESPU Research Committee Protocol Template - Research Question | DOCX",1788275591]