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Provides standardized instructions for completing key sections such as principal investigator details, abbreviations, abstract, background and significance, hypotheses and specific aims, study design, study population, outcomes, statistical considerations, and data management. Includes guidance for citations, references, spell check, required IRB submission packaging, and optional items like publication plan and attachments.",{"@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/protocol-template-for-retrospective-studies-general-instructions/170792/",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/protocol-template-for-retrospective-studies-general-instructions/170792.png","ImageObject",442,249,{"name":88,"@type":89},"WPS_1786070896","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/octet-stream","2026-10-23","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":25},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"When should the retrospective protocol template be used for IRB submission?","Question",{"text":108,"@type":109},"Use it only when the study will rely on data and/or samples that have already been collected and are available at the time of IRB submission.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What should be included in the protocol abstract?",{"text":113,"@type":109},"The abstract must summarize the most important aspects of the protocol, including the study type (e.g., Retrospective Cohort or Case-Control) and the main inclusion criteria, while detailed information goes into the body.",{"name":115,"@type":106,"acceptedAnswer":116},"What formatting and submission steps are required before sending to the IRB?",{"text":117,"@type":109},"Delete highlighted instructional text, mark non-applicable sections as “Not Applicable,” update the table of contents as needed, add references using supported Word/reference tools, run spell check, and submit the protocol together with the IRB Submission Form and other required information.","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},170792,1788275564,{"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":25,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":20,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":125,"read_time":47},549768072016,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Protocol Template for Retrospective Studies (Using Existing Data Only)\nGENERAL INSTRUCTIONS\nUse this protocol template ONLY if your study will use data and/or samples that have already been collected and are on the shelf at the time of submission to the IRB.\nHighlighted text [yellow] contains instructions and should be deleted.\nText that is not highlighted is provided as example only, and should be modified to reflect the specifics of your study.\nIf section is not applicable, write “Not Applicable” under header\nIf you are adding sections use heading font in style list (this will ensure title appears in table of contents)\nTo update the Table of Contents, move cursor to the Table (text will turn grey) and hit F9.  Choose option to update entire table.\nTo insert references, you may use either the RefWorks application, the Insert/References/Endnotes function in Word, or any other reference application.\nRun spell check prior to submitting\nFor assistance with sample size or statistical analysis plan, contact the Biostatistics & Research Data Core, Center for Health Research (570-214-9825, biostatistics@geisinger.edu).\nSubmit the protocol with the IRB Submission Form and other required information to the IRB.\nPlease remove this page from your protocol.\n\u000f\n[Insert Title]\nPrincipal Investigator:\t\t\tName\nAddress\nTelephone\n\u000fTABLE OF CONTENTS (Remove if LEss than 10 PAGES)\n\u0013 TOC \\o \"3-3\" \\h \\z \\t \"Heading 1,1,Heading 2,2,Appendix,1,Heading 0,1,Heading Centered,1,INV_Heading 1,1,INV_Heading 2,2,INV_Heading 3,3\" \\w \u0014\u0013 HYPERLINK \\l \"_Toc215372898\" \u00141.0\tABBREVIATIONS USED in the protocol\t\u0013 PAGEREF _Toc215372898 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372899\" \u00142.0\tAbstract\t\u0013 PAGEREF _Toc215372899 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372900\" \u00143.0\tBACKGROUND AND Significance\t\u0013 PAGEREF _Toc215372900 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372901\" \u00144.0\tHypotheses and Specific aims\t\u0013 PAGEREF _Toc215372901 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372902\" \u00144.1\tSpecific Aim 1\t\u0013 PAGEREF _Toc215372902 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372903\" \u0014State aim and briefly explain how you will accomplish the aim.\t\u0013 PAGEREF _Toc215372903 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372904\" \u00144.1.1\tHypothesis 1\t\u0013 PAGEREF _Toc215372904 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372905\" \u0014Make sure it is understandable, testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections. Be sure to explain how the results to be obtained will be used to test the hypothesis.\t\u0013 PAGEREF _Toc215372905 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372906\" \u00144.1.2\tHypothesis 2\t\u0013 PAGEREF _Toc215372906 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372907\" \u00144.2\tSpecific Aim 2\t\u0013 PAGEREF _Toc215372907 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372908\" \u00144.2.1\tHypothesis 1\t\u0013 PAGEREF _Toc215372908 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372909\" \u00145.0\tPreliminary data (If Applicable)\t\u0013 PAGEREF _Toc215372909 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372910\" \u00146.0\tSTUDY DESIGN\t\u0013 PAGEREF _Toc215372910 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372911\" \u00146.1\tDescription\t\u0013 PAGEREF _Toc215372911 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372912\" \u00146.2\tStudy Population\t\u0013 PAGEREF _Toc215372912 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372913\" \u00146.2.1\tInclusion Criteria\t\u0013 PAGEREF _Toc215372913 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372914\" \u00146.2.2\tExclusion Criteria\t\u0013 PAGEREF _Toc215372914 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372915\" \u00146.3\tStudy Date Range\t\u0013 PAGEREF _Toc215372915 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372916\" \u00146.4\tApproximate Number of Patients\t\u0013 PAGEREF _Toc215372916 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372917\" \u00146.5\tData Collection\t\u0013 PAGEREF _Toc215372917 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372918\" \u00146.6\tPrimary Outcome\t\u0013 PAGEREF _Toc215372918 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372919\" \u00146.7\tSecondary Outcome(s)\t\u0013 PAGEREF _Toc215372919 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372920\" \u00146.8\tStatistical Considerations\t\u0013 PAGEREF _Toc215372920 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372921\" \u00146.8.1\tStatistical Analysis Plan\t\u0013 PAGEREF _Toc215372921 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215372922\" \u00146.8.2\tStatistical Power and Sample Size Considerations\t\u0013 PAGEREF _Toc","cbCaifH7xWi5WUyn","https://ap.wps.com/l/cbCaifH7xWi5WUyn","doc",105984,"English","# ABBREVIATIONS USED in the protocol\n# Abstract\n# BACKGROUND AND Significance\n# Hypotheses and Specific aims\n## Specific Aim 1\n## Hypothesis 1\n## Hypothesis 2\n## Specific Aim 2\n## Hypothesis 1\n# Preliminary data (If Applicable)\n# STUDY DESIGN\n## Description\n## Study Population\n## Inclusion Criteria\n## Exclusion Criteria\n## Study Date Range\n## Approximate Number of Patients\n## Data Collection\n## Primary Outcome\n## Secondary Outcome(s)\n## Statistical Considerations\n## Statistical Analysis Plan\n## Statistical Power and Sample Size Considerations\n## Data Management\n## Data Collection and Storage\n## Records Retention\n## Study Timeline\n# Protection of human subjects\n## Protection of Human Subjects Against Confidentiality Risks\n# PUBLICATION Plan (Optional)\n# REFERENCES\n# ATTACHMENTS\n## Attachment 1: Title","[{\"question\":\"When should the retrospective protocol template be used for IRB submission?\",\"answer\":\"Use it only when the study will rely on data and/or samples that have already been collected and are available at the time of IRB submission.\"},{\"question\":\"What should be included in the protocol abstract?\",\"answer\":\"The abstract must summarize the most important aspects of the protocol, including the study type (e.g., Retrospective Cohort or Case-Control) and the main inclusion criteria, while detailed information goes into the body.\"},{\"question\":\"What formatting and submission steps are required before sending to the IRB?\",\"answer\":\"Delete highlighted instructional text, mark non-applicable sections as “Not Applicable,” update the table of contents as needed, add references using supported Word/reference tools, run spell check, and submit the protocol together with the IRB Submission Form and other required information.\"}]","Protocol Template for Retrospective Studies - General Instructions | DOC"]