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It helps investigators include the essential protocol elements aligned with ICH E6 Good Clinical Practice, supporting Institutional Review Board evaluation of participant risks and benefits. Guidance covers study oversight, safety assessment, clinical site monitoring, intervention section selection, amendment requirements after IRB approval, and formatting conventions for required versus sample text and placeholders.",{"@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":46,"@type":70,"position":76},"https://docshare.wps.com/template/paper-templates/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/nidcr-interventional-protocol-template-instructional-template-for-interventional-studies/167767/",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/nidcr-interventional-protocol-template-instructional-template-for-interventional-studies/167767.png","ImageObject",442,249,{"name":88,"@type":89},"Seraphina","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-07","2026-08-31",true,{"@type":98,"interactionType":99,"userInteractionCount":47},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What type of studies is the NIDCR interventional protocol template intended for?","Question",{"text":108,"@type":109},"It is intended for interventional studies that are not NIH Phase 2 or 3 clinical trials conducted under an FDA IND or IDE application.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What standard is the template based on?",{"text":113,"@type":109},"The template is based on essential protocol elements reflected in Section 6 of the ICH E6 guideline for Good Clinical Practice.",{"name":115,"@type":106,"acceptedAnswer":116},"What should investigators do if an amendment is needed before implementation?",{"text":117,"@type":109},"Protocol changes via amendment cannot be implemented until IRB approval is received.","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},167767,1788219114,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":45,"category_name":46,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":47,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":125,"read_time":140},962075114101,"https://ap-avatar.wpscdn.com/avatar/e000253a75eb197efd?x-image-process=image/resize,m_fixed,w_180,h_180&k=1780044092746381165","Tool Summary Sheet:\nNIDCR Interventional Protocol Template\nPurpose:  To provide an instructional template for use in development of a protocol for studies using an intervention (biomedical or behavioral)\nNOTE:  If the protocol is for a Phase 2 or 3 clinical trial funded by the National Institutes of Health (NIH) that is being conducted under a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application, investigators are encouraged to use the NIH protocol template found here:  \u0013 HYPERLINK \"https://osp.od.nih.gov/clinical-research/clinical-trials/\" \\o \"Clinical Trials Office of Science Policy\" \u0014https://osp.od.nih.gov/clinical-research/clinical-trials/\u0015.\nAudience/User\nPrincipal Investigators and Study Staff\nDetails\nThis document is the National Institute of Dental and Craniofacial Research (NIDCR) protocol template for an interventional study that is NOT a phase 2 or 3 clinical trial being conducted under an IND or IDE Application.\nThe NIH defines a \u0013 HYPERLINK \"https://grants.nih.gov/policy/clinical-trials/definition.htm\" \\o \"clinical trial\" \u0014clinical trial \u0015as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.  However, researchers conducting studies with interventions that do not meet the NIH definition of a clinical trial may consider using this template. This protocol template is based on the essential protocol elements in Section 6 of the \u0013 HYPERLINK \"http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf\" \\o \"ICH E6 guideline for Good Clinical Practice\" \u0014ICH E6 guideline for Good Clinical Practice\u0015.  The template will assist investigators in preparing an interventional study protocol that meets NIDCR standards and includes all elements required for an Institutional Review Board (IRB) to assess study risks and benefits.\nBest Practice Recommendations\nThe IRB’s risk assessment and the complexity of the study are used by the NIDCR to determine the resources needed to meet the Institute’s study oversight responsibilities.  Based on the potential risk for participants and the complexity of the study, the NIDCR Medical Monitor will provide guidance on the appropriate level of data and safety monitoring.  Investigators should consult the NIDCR Program Official when writing the protocol template sections on Assessment of Safety, Study Oversight, and Clinical Site Monitoring.\nThe Grantee Institution may have an IRB-specified protocol format.  Use of that IRB format is acceptable to NIDCR, provided the necessary elements (the section headings included in the template table of contents) are included in the protocol.  A grant application is generally not acceptable as a protocol. Pasting text from the grant application will not usually meet the requirements for an acceptable protocol.\nChanges to the protocol via an amendment cannot be implemented until IRB approval is received.\nTerminology has been consistently applied throughout this template but can be updated to reflect appropriate study-specific terminology (e.g., participant / subject, case report form / data collection form).\nThe Study Intervention section (Section 6) of this template includes sub-sections for:\nStudy Product, such as an investigational or approved drug or device (Sections 6.1 - 6.6);\nBehavioral Intervention (Sections 6.7 - 6.10) and;\nProcedural Intervention (Section 6.11 - 6.14).\nChoose the appropriate section that matches the type of study intervention planned and delete the other sections.\nRefer questions regarding use of this protocol template to the appropriate NIDCR Program Official or the NIDCR Office of Clinical Trials Operations and Management (OCTOM).\nTechnical/Formatting Notes\nIn the template, instructions for each section are included in {b","cbCaikPHK4LehLv3","https://ap.wps.com/l/cbCaikPHK4LehLv3","docx",160449,74,"English","# Tool Summary Sheet\n## Purpose and Intended Use\n## Audience and Scope\n## Core Foundations and Regulatory Context\n## Best Practice Recommendations\n## Study Protocol Content Guidance\n## Technical and Formatting Notes","[{\"question\":\"What type of studies is the NIDCR interventional protocol template intended for?\",\"answer\":\"It is intended for interventional studies that are not NIH Phase 2 or 3 clinical trials conducted under an FDA IND or IDE application.\"},{\"question\":\"What standard is the template based on?\",\"answer\":\"The template is based on essential protocol elements reflected in Section 6 of the ICH E6 guideline for Good Clinical Practice.\"},{\"question\":\"What should investigators do if an amendment is needed before implementation?\",\"answer\":\"Protocol changes via amendment cannot be implemented until IRB approval is received.\"}]","NIDCR Interventional Protocol Template - Instructional template for interventional studies | DOCX",26]