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Includes instructions on removing italics-based instructional text and footnotes, while retaining or adapting regular-font example text by inserting study-specific details into angle-bracket placeholders. Covers how to use section headers for a table of contents and emphasizes version control by updating footer version number and date with each revision, while preserving protocol amendment history for changes to approved final versions.","How To Use This Template\nIt is important to incorporate all sections of the template into your protocol and to do so in the same order.  If a particular section is not applicable to your trial, include it, but indicate that it is not applicable.\nThis template contains two types of text:  instruction/explanatory and example.\nInstruction/explanatory text are indicated by italics and should deleted. Footnotes to instructional text should also be deleted.  This text provides information on the content that should be included.  It also notes if a section should be left blank.  For example, many headings include the instruction, “No text is to be entered in this section; rather it should be included under the relevant subheadings below.”\nExample text is included to further aid in protocol writing and should either be modified to suit the drug, biologic or device (study intervention), design, and conduct of the planned clinical trial or deleted.  Example text is indicated in [regular font].  Within example text, a need for insertion of specific information is notated by \u003Cangle brackets>.\nInstruction/explanatory text should be deleted.  Example text can be incorporated as written or tailored to a particular protocol.  If it is not appropriate to the protocol, however, it too should be deleted. The section headers include formatting to generate a table of contents.\nVersion control is important to track protocol development, revisions, and amendments.  It is also necessary to ensure that the correct version of a protocol is used by all staff conducting the study. With each revision, the version number and date located in the footer of each page should be updated.  When making changes to an approved and “final” protocol, the protocol amendment history should be maintained (see Section 10.4). \u000f\n\u003CTitle>\nThe title should be easy to remember, recognizable by administrative support staff, and sufficiently different from other protocol titles to avoid confusion. Brevity with specificity and neutrality is the goal.  If there is a “short title” (e.g., an abbreviation used to refer to the study title, include here and that can be used throughout this document in place of the full title).\nProtocol Number: \u003C Number>\nNational Clinical Trial (NCT) Identified Number:  \u003CNumber, if available>\nPrincipal Investigator: \u003C Principal Investigator>\n\u003CIND/IDE> Sponsor: \u003CSponsor name, if applicable>\nSponsor means an individual or pharmaceutical or medical device company, governmental agency, academic institution, private organization, or other organization who takes responsibility for and initiates a clinical investigation.\nFunded by: \u003C NIH Institute or Center (IC)>\nVersion Number:  v.\u003Cx.x>\n\u003CDay Month Year>\nAll versions should have a version number and a date. Use the international date format (day month year) and write out the month (e.g., 23 June 2015).\nSummary of Changes from Previous Version:\n\u0003Table of Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc479192697\" \u0014STATEMENT OF COMPLIANCE\t\u0013 PAGEREF _Toc479192697 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc479192698\" \u00141\tPROTOCOL SUMMARY\t\u0013 PAGEREF _Toc479192698 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc479192699\" \u00141.1\tSynopsis\t\u0013 PAGEREF _Toc479192699 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc479192700\" \u00141.2\tSchema\t\u0013 PAGEREF _Toc479192700 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc479192701\" \u00141.3\tSchedule of Activities (SoA)\t\u0013 PAGEREF _Toc479192701 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc479192702\" \u00142\tINTRODUCTION\t\u0013 PAGEREF _Toc479192702 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc479192703\" \u00142.1\tStudy Rationale\t\u0013 PAGEREF _Toc479192703 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc479192704\" \u00142.2\tBackground\t\u0013 PAGEREF _Toc479192704 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc479192705\" \u00142.3\tRisk/Benefit Assessment\t\u0013 PAGEREF _Toc479192705 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc479192706\" \u00142.3.1\tKnown Potential Risks\t\u0013 PAGEREF _Toc479192706 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc479192707\" \u00142.3.2\tKnown Potential Benefits\t\u0013 PAGEREF _Toc479192707 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc479192708\" \u00142.3.3\tAssessment of Potential Risks and Benefits\t\u0013 PAGEREF _Toc4791927","cbCaij8qdjHBB7vj","https://ap.wps.com/l/cbCaij8qdjHBB7vj","docx",355877,4,64,"English","en",105,"# STATEMENT OF COMPLIANCE\n# PROTOCOL SUMMARY\n## Synopsis\n## Schema\n## Schedule of Activities (SoA)\n# INTRODUCTION\n## Study Rationale\n## Background\n## Risk/Benefit Assessment\n### Known Potential Risks\n### Known Potential Benefits\n### Assessment of Potential Risks and Benefits\n# OBJECTIVES AND ENDPOINTS\n# STUDY DESIGN\n## Overall Design\n## Scientific Rationale for Study Design\n## Justification for Dose\n## End of Study Definition\n# STUDY POPULATION\n## Inclusion Criteria\n## Exclusion Criteria\n## Lifestyle Considerations\n## Screen Failures\n## Strategies for Recruitment and Retention\n# STUDY INTERVENTION\n## Study Intervention(s) Administration\n### Study Intervention Description\n### Dosing and Administration\n## Preparation/Handling/Storage/Accountability\n### Acquisition and accountability\n### Formulation, Appearance, Packaging, and Labeling\n### Product Storage and Stability\n### Preparation","[{\"question\":\"How should the protocol template sections be incorporated into the final clinical trial protocol?\",\"answer\":\"Include all template sections in the same order. If a section does not apply, keep it but indicate that it is not applicable.\"},{\"question\":\"What should be done with instructional text and footnotes in the template?\",\"answer\":\"Instruction/explanatory text indicated in italics should be deleted, including any footnotes tied to instructional text. Use the content guidance to determine what sections should be left blank.\"},{\"question\":\"How is version control handled when revising an approved or final protocol?\",\"answer\":\"Update the version number and date in the footer of each page with every revision. Maintain the protocol amendment history when making changes to an approved final protocol.\"}]","Clinical Trial Protocol Template - Instruction and Example Guidance | DOCX",1788160187,22,{"code":4,"msg":77,"data":78},"ok",{"site_id":70,"language":69,"slug":79,"title":59,"keywords":80,"description":60,"schema_data":81,"social_meta":136,"head_meta":138,"extra_data":140,"updated_unix":74},"clinical-trial-protocol-template-instruction-and-example-guidance","",{"@graph":82,"@context":135},[83,98,118],{"@type":84,"itemListElement":85},"BreadcrumbList",[86,90,93,96],{"item":87,"name":88,"@type":89,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":91,"name":10,"@type":89,"position":92},"https://docshare.wps.com/template/",2,{"item":94,"name":36,"@type":89,"position":95},"https://docshare.wps.com/template/forms/",3,{"item":97,"name":59,"@type":89,"position":66},"https://docshare.wps.com/template/clinical-trial-protocol-template-instruction-and-example-guidance/164748/",{"url":97,"name":59,"@type":99,"image":100,"author":105,"headline":59,"publisher":107,"fileFormat":110,"inLanguage":69,"description":60,"dateModified":111,"datePublished":112,"encodingFormat":110,"isAccessibleForFree":113,"interactionStatistic":114},"DigitalDocument",{"url":101,"@type":102,"width":103,"height":104},"https://docshare.wps.com/thumbnails/clinical-trial-protocol-template-instruction-and-example-guidance/164748.png","ImageObject",442,249,{"name":57,"@type":106},"Person",{"url":87,"name":108,"@type":109},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-23","2026-08-31",true,{"@type":115,"interactionType":116,"userInteractionCount":66},"InteractionCounter",{"@type":117},"ViewAction",{"@type":119,"mainEntity":120},"FAQPage",[121,127,131],{"name":122,"@type":123,"acceptedAnswer":124},"How should the protocol template sections be incorporated into the final clinical trial protocol?","Question",{"text":125,"@type":126},"Include all template sections in the same order. 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