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The template outlines essential protocol components including investigator and site information, study synopsis, population, design, sample size, duration, primary and secondary objectives, background and significance with cited literature, and a detailed objectives section. It also specifies methodology expectations, inclusion/exclusion criteria, study timeline, statistical analysis planning, sample size rationale, missing-data handling, and consent process considerations.","Study Protocol Template  \n(Chart Reviews)  \nInstructions:  \nThis protocol template is a tool to facilitate the development of a study protocol specifically designed for the investigator initiated studies. It contains sample text to assist investigators in answering the questions reviewers may have. Protocol template instructions and samples are in italics. Please delete the italicized text and the instructions after you complete each section. It is recommended that section headings in the protocol template should not be deleted. It facilitates the review process. If the heading does not relate to your study insert N/A.  \nStart from here:  \nStudy Protocol Title:  \nBe consistent with the Title through out your application, protocol and the regulatory documents  \nTable of Contents:  \nList of Abbreviations:  \nUse commonly used abbreviations and acronym.  \nPrincipal Investigator, Research Team, and Study Site:  \nPrincipal investigator:  \nCo-Investigators:  \nResearch team and contact Information:  \nStudy site:  \nResearch Synopsis  \nStudy Title  \nEnter the full title  \nStudy Population  \nInclude a brief description of the population such as health status, gender, age, etc.  \nStudy Design  \nPresent an overview of the study design for example, retrospective chart review, data or specimen collection etc  \nSample Size  \nInclude total number of patients or chartsfor the study including other sites.  \nStudy Duration  \nLength of time to review charts, data collection, and analysis till the completion of the study  \nPrimary Objective  \nInclude primary objective and outcome measures  \nSecondary Objectives  \nInclude secondary objective and, outcome measures  \nBackground and Significance:  \nThis section is based on your research question. How are the possible answers to the question explained and defended? What are assumptions and relationships? What are the working hypotheses? Justification of your conducting this study based on existing knowledge and your research question.  \nDescribe the disease including incidence. Provide a summary of previous pre-clinical studies, relevant clinical studies, or any epidemiological data if available  \nInclude references with citations from the literature.  \nIn the last paragraph state the main purpose of the study summarizing all the information provided in your background section.  \nObjectives:  \nThese should be defined after the theoretical outline has been developed. The sequence should be clear between the primary question and possible responses to the questions or hypotheses. The objectives are the intellectual activities that the investigator will perform throughout the research study.  \nPrimary Objective  \nInclude the details of your primary objective (which is your main purpose ofperforming this  \nstudy and should be focused on one question), outcome measures and method by which outcomes  \nwill be determined.  \nSample Text: To evaluate the efficacy of antibiotics in the treatment of acute bronchitis  \nSecondary Objectives  \nInclude secondary objectives which can be two or three can be dependent or independent of the primary objective, outcome measures and method by which secondary outcomes will be determined.  \nSample text: To assess patients overall change in symptoms and return to daily activities after 2 weeks of antibiotic treatment  \nTo evaluate management and treatment factors as potential predictors of outcome.  \nStudy design/methodology:  \nInclude the description of study type, for example prospective data or specimen collection, retrospective, or observational, survey, or questionnaire  \nType of study and design should be decided on the basis of proposed objectives and the availability of the resources.  \nThe methodology explains the procedures that will be used to achieve the objectives. In this section the definition for the variables used should be specified in detail, along with the type of variablesand the ways to measure them.  \nExample text: This is a retrospective chart review of pa","cbCairNproMbrA5H","https://ap.wps.com/l/cbCairNproMbrA5H","pdf",22651,"English","en",105,"# Study Protocol Title\n## Table of Contents\n## List of Abbreviations\n# Principal Investigator, Research Team, and Study Site\n## Principal Investigator\n## Co-Investigators\n## Research Team and Contact Information\n## Study Site\n# Research Synopsis\n## Study Title\n## Study Population\n## Study Design\n## Sample Size\n## Study Duration\n# Objectives\n## Primary Objective\n## Secondary Objectives\n# Background and Significance\n# Study Design/Methodology\n# Inclusion / Exclusion Criteria\n# Study Duration / Study Timeline\n# Statistical Analysis Plan\n## Sample Size Determination\n# Informed Consent Process","[{\"question\":\"What is the purpose of this chart review study protocol template?\",\"answer\":\"It facilitates development of an investigator-initiated study protocol by providing sample text and instructions to help investigators answer reviewer questions and complete each required protocol section.\"},{\"question\":\"Which key protocol sections should be filled out?\",\"answer\":\"The template guides completion of study title and synopsis, population and design, sample size and duration, primary and secondary objectives with outcome measures, background and significance with citations, methodology and variable definitions, and study timeline.\"},{\"question\":\"What guidance is given for statistical analysis and sample size?\",\"answer\":\"It instructs investigators to consult a biostatistician, specify the sample size and power rationale, include calculations and clinical justification, and provide a plan for accounting for missing, unused, and spurious data.\"}]","Study Protocol Template - Chart Reviews - Instructions and Sample Sections | PDF",1789199081,2,{"code":4,"msg":75,"data":76},"ok",{"site_id":68,"language":67,"slug":77,"title":59,"keywords":78,"description":60,"schema_data":79,"social_meta":134,"head_meta":136,"extra_data":138,"updated_unix":72},"study-protocol-template-chart-reviews-instructions-and-sample-sections","",{"@graph":80,"@context":133},[81,96,116],{"@type":82,"itemListElement":83},"BreadcrumbList",[84,88,90,93],{"item":85,"name":86,"@type":87,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":89,"name":10,"@type":87,"position":73},"https://docshare.wps.com/template/",{"item":91,"name":36,"@type":87,"position":92},"https://docshare.wps.com/template/forms/",3,{"item":94,"name":59,"@type":87,"position":95},"https://docshare.wps.com/template/study-protocol-template-chart-reviews-instructions-and-sample-sections/243053/",4,{"url":94,"name":59,"@type":97,"image":98,"author":103,"headline":59,"publisher":105,"fileFormat":108,"inLanguage":67,"description":60,"dateModified":109,"datePublished":110,"encodingFormat":108,"isAccessibleForFree":111,"interactionStatistic":112},"DigitalDocument",{"url":99,"@type":100,"width":101,"height":102},"https://docshare.wps.com/thumbnails/study-protocol-template-chart-reviews-instructions-and-sample-sections/243053.png","ImageObject",442,249,{"name":57,"@type":104},"Person",{"url":85,"name":106,"@type":107},"DocShare","Organization","application/pdf","2026-10-09","2026-09-12",true,{"@type":113,"interactionType":114,"userInteractionCount":15},"InteractionCounter",{"@type":115},"ViewAction",{"@type":117,"mainEntity":118},"FAQPage",[119,125,129],{"name":120,"@type":121,"acceptedAnswer":122},"What is the purpose of this chart review study protocol template?","Question",{"text":123,"@type":124},"It facilitates development of an investigator-initiated study protocol by providing sample text and instructions to help investigators answer reviewer questions and complete each required protocol section.","Answer",{"name":126,"@type":121,"acceptedAnswer":127},"Which key protocol sections should be filled out?",{"text":128,"@type":124},"The template guides completion of study title and synopsis, population and design, sample size and duration, primary and secondary objectives with outcome measures, background and significance with citations, methodology and variable definitions, and study timeline.",{"name":130,"@type":121,"acceptedAnswer":131},"What guidance is given for statistical analysis and sample size?",{"text":132,"@type":124},"It instructs investigators to consult a biostatistician, specify the sample size and power rationale, include calculations and clinical justification, and provide a plan for accounting for missing, unused, and spurious data.","https://schema.org",{"og:url":94,"og:type":135,"og:title":59,"og:site_name":106,"og:description":60},"article",{"robots":137,"canonical":94},"index,follow",{"doc_id":55,"site_id":68}]