[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-170963-105":53,"doc-detail-170963-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","protocol-synopsis-intervention-study-protocol-template","Protocol Synopsis - Intervention Study Protocol Template","","Clinical trial protocol synopsis template for intervention studies, intended to summarize study scope, design, schedule, and rationale for lay reviewers and primary reviewers. It specifies how to structure and limit the synopsis length to 2–3 pages, use brief bullet points, and include example study procedures tables and a study diagram. The template guides development of background, investigational product/intervention description, non-clinical and clinical findings, compliance statements, study objectives, and investigational plan elements such as screening, baseline assessment, and overall study design phases.",{"@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":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/protocol-synopsis-intervention-study-protocol-template/170963/",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-synopsis-intervention-study-protocol-template/170963.png","ImageObject",442,249,{"name":88,"@type":89},"Ethan Miller","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-19","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":8},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the purpose of the protocol synopsis in this template?","Question",{"text":108,"@type":109},"The synopsis provides an overview of the study for lay members and those who are not primary reviewers, while remaining brief and focused on key information.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How long should the protocol synopsis be and how should it be formatted?",{"text":113,"@type":109},"Limit the synopsis to no more than 2–3 pages, keep it brief, and use bullet points.",{"name":115,"@type":106,"acceptedAnswer":116},"What sections and elements does the template include to describe the study?",{"text":117,"@type":109},"It covers background and rationale, intervention/product description, non-clinical and clinical findings, compliance statements, study objectives, and an investigational plan including study design schema and screening/baseline assessment.","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},170963,1791720720,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":8,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":45,"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":139,"read_time":140},687207017582,"https://ap-avatar.wpscdn.com/davatar_994ba38a5ba835b3df7d355c54d3ed8d","Protocol\nThis template is intended to be used for clinical trials and can be modified to accommodate a variety of intervention study designs. Intervention studies, in their broadest sense, includes any study design that involves an intervention regardless of the nature of that intervention (drug, biologic, device or other strategy) or method of treatment assignment (non-random process or randomization).\nSections that are not applicable can be filled in simply with “not applicable” and justification. Delete all of blue and red sections when the protocol is complete.\nProtocol Synopsis\n(Do NOT include a Synopsis if submitting protocol for expedited review.)\nLIMIT SYNOPSIS to no more than 2 - 3 pages. The synopsis provides an overview of the study for lay members and for members who are not the primary reviewers. Keep the synopsis BRIEF. Use bullet points.\nTable 1: Schedule of Study Procedures\nThis table is an example of a schedule of procedures. The Investigator should construct a table based on the procedures in the protocol. If the study involves more than 1 or 2 visits, it is often preferable to include this table as an Appendix to the Consent Form. This simplifies the consent form.\n.\nFigure 1: Study Diagram\nA flow diagram of the study may be relevant to explain the flow of subjects in the trial. An example flow diagram for randomized, controlled clinical trial design is included below.\n.\nBackground Information and Rationale\nThe background and rationale should be no more than 3 – 5 pages. Refer the reader to the applicable grant or attached literature references for more detailed information.  If referring to the grant it is helpful to include page citations.\nName and Description of Investigational Product or Intervention\nName and description of the study intervention (drug, device, diagnostic, diet, or experimental psychological therapy). If a drug, device or biologic include the specific description, packaging and control systems will go in Section 7.\nFindings from Non-Clinical and Clinical Studies\n(This section is only applicable for drugs, biologics and devices.)\nNon-Clinical Studies\nClinical Studies\nHuman Pharmacokinetics\nClinical Studies in Adults\nClinical Studies in Children\nSelection of Drugs and Dosages\nDescription of dosage forms available and those to be used in study\nRelevant References\nCompliance Statement\nThis study will be conducted in full accordance of all applicable Hennepin Healthcare Research Policies and Procedures and all applicable Federal and State laws and regulations. All episodes of noncompliance will be documented and reported according to the Prompt Reporting Guidelines, Attachment EEE, of the Hennepin Healthcare IRB Policies and Procedures.\nThe investigators will perform the study in accordance with this protocol, will obtain consent and assent, unless waiver of consent or other alteration is approved, and will report unanticipated problems involving risks to subjects or others and SAEs in accordance with The Hennepin Healthcare IRB Policies and Procedures and all Federal requirements. Collection, recording, and reporting of data will be accurate and will ensure the privacy, health, and welfare of research subjects during and after the study.\nStudy Objectives\nState the overall objectives of the study.\nThe purpose of the study is to determine the (efficacy, pharmacokinetics, safety) of ….\nPrimary Objective (or Aim)\nThe primary objective of this study is to determine whether the XXX (intervention) reduces, increases, etc. outcome measure XXX in adults X to X years. This should be specific; for example:  to determine if enalapril decreases systolic blood pressure after 4 weeks compared to placebo.\nThe primary objective should be both the most important and the objective on which the study sample size is based. Objectives (aims) are usually phrased in some variant of “…to determine…” Protocols differ from grants in that they do not usually enumerate specific hypotheses. If included, these belong in th","cbCaia6w60bQDrsU","https://ap.wps.com/l/cbCaia6w60bQDrsU","docx",364971,"English","# Protocol\n## Protocol Synopsis\n## Table 1: Schedule of Study Procedures\n## Figure 1: Study Diagram\n## Background Information and Rationale\n## Name and Description of Investigational Product or Intervention\n## Findings from Non-Clinical and Clinical Studies\n### Non-Clinical Studies\n### Clinical Studies\n## Compliance Statement\n## Study Objectives\n### Primary Objective (or Aim)\n### Secondary Objectives (or Aim)\n## Investigational plan\n### General Schema of Study Design\n### Screening Phase and Baseline Assessment","[{\"question\":\"What is the purpose of the protocol synopsis in this template?\",\"answer\":\"The synopsis provides an overview of the study for lay members and those who are not primary reviewers, while remaining brief and focused on key information.\"},{\"question\":\"How long should the protocol synopsis be and how should it be formatted?\",\"answer\":\"Limit the synopsis to no more than 2–3 pages, keep it brief, and use bullet points.\"},{\"question\":\"What sections and elements does the template include to describe the study?\",\"answer\":\"It covers background and rationale, intervention/product description, non-clinical and clinical findings, compliance statements, study objectives, and an investigational plan including study design schema and screening/baseline assessment.\"}]","Protocol Synopsis - Intervention Study Protocol Template | DOCX",1788278324,7]