[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-172694-105":53,"doc-detail-172694-en":118},{"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":111,"head_meta":113,"extra_data":115,"updated_unix":117},105,"en","template-sbs-protocol-hrp-503sbs-study-summary","TEMPLATE SBS PROTOCOL (HRP-503(SBS)) - Study Summary","","Study Summary section instructions for preparing the “TEMPLATE SBS PROTOCOL (HRP-503(SBS))” protocol document. Guides the selection of applicable sections by study type, use of “NA” where required, and compliance caution to address IRB requests. Specifies what to include for protocol title, principal investigator details, version and revision history, and provides structured content prompts for objectives, background, and study endpoints, including hypotheses, rationale, endpoints, intervention description, and procedures, data collection, and safety-related monitoring.",{"@graph":63,"@context":110},[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/template-sbs-protocol-hrp-503sbs-study-summary/172694/",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/template-sbs-protocol-hrp-503sbs-study-summary/172694.png","ImageObject",442,249,{"name":88,"@type":89},"Emma Wilson","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-20","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":15},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104],{"name":105,"@type":106,"acceptedAnswer":107},"How should study endpoints and interventions be described?","Question",{"text":108,"@type":109},"Describe primary and secondary study endpoints. Provide a clear description of the study intervention being evaluated, then explain the study design and procedures, including safety monitoring and timing of procedures.","Answer","https://schema.org",{"og:url":78,"og:type":112,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":114,"canonical":78},"index,follow",{"doc_id":116,"site_id":56},172694,1791700679,{"code":4,"msg":5,"data":119},{"doc_id":116,"user_id":120,"nickname":88,"user_avatar":121,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":122,"file_id":123,"file_url":124,"file_type":125,"file_size":126,"view_count":15,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":30,"language":127,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":128,"faqs":129,"seo_title":130,"seo_description":61,"update_tm":131,"read_time":132},3848291630094,"https://eur-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45","INSTRUCTIONS:\nUse “TEMPLATE SBS PROTOCOL (HRP-503(SBS))” to prepare a document with the information from the following sections.\nDepending on the nature of your study, some sections may not be applicable to your research. If so you may mark as “NA”. For example—\nResearch that only involves educational tests, survey or interview procedures, focus groups or observation of public behavior; for this type of research the following sections may not be applicable: Provisions to Monitor the Data to Ensure the Safety of Subjects (Section 18, IF no sensitive identifiable information is being recorded), Compensation for Research-Related Injury (Section 20), and Economic Burden to Subjects (Section 21).\nResearch involving only secondary research use of previously collected information; for this type of research the following sections may not be applicable: Study Intervention/Investigational Agent (Section 5), Recruitment Methods (Section 13), Provisions to Monitor the Data to Ensure the Safety of Subjects (Section 18, IF no sensitive identifiable information is being recorded), or Economic Burden to Subjects (Section 21).\nResearch that specifically excludes as study subjects the following: pregnant women, neonates, children, prisoners, and persons who may be cognitively impaired; for this research, the following section may not be applicable: Vulnerable Populations (Section 11).\nUse caution however; the IRB may upon its own review ask you to clarify or revise any “NA” response.\nWhen you write a protocol, keep an electronic copy. You will need to modify this copy when making changes.\nAs you are writing the protocol, remove all instructions in italics so that they are not contained in the final version of your protocol.\nOmit starred (*) items only if this is the activation of a protocol at a new site or sites that will be overseen by a principal investigator who will take separate and full responsibility for that site or those sites. Complete by describing information specific to the site(s). Do not repeat information in the approved protocol that applies to all site(s).\nPROTOCOL TITLE:\nInclude the full protocol title.\nPRINCIPAL INVESTIGATOR:\nName\nDepartment\nTelephone Number\nEmail Address\nVERSION NUMBER/DATE:\nInclude the version number and date of this protocol.\nREVISION HISTORY\n\u000f\nTable of Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc496162129\" \u00141.0\tStudy Summary\t\u0013 PAGEREF _Toc496162129 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162130\" \u00142.0\tObjectives*\t\u0013 PAGEREF _Toc496162130 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162131\" \u00143.0\tBackground*\t\u0013 PAGEREF _Toc496162131 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162132\" \u00144.0\tStudy Endpoints*\t\u0013 PAGEREF _Toc496162132 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162133\" \u00145.0\tStudy Intervention/Investigational Agent\t\u0013 PAGEREF _Toc496162133 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162134\" \u00146.0\tProcedures Involved*\t\u0013 PAGEREF _Toc496162134 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162135\" \u00147.0\tData and Specimen Banking*\t\u0013 PAGEREF _Toc496162135 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162136\" \u00148.0\tSharing of Results with Subjects*\t\u0013 PAGEREF _Toc496162136 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162137\" \u00149.0\tStudy Timelines*\t\u0013 PAGEREF _Toc496162137 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162138\" \u001410.0\tInclusion and Exclusion Criteria*\t\u0013 PAGEREF _Toc496162138 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162139\" \u001411.0\tVulnerable Populations*\t\u0013 PAGEREF _Toc496162139 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162140\" \u001412.0\tLocal Number of Subjects\t\u0013 PAGEREF _Toc496162140 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162141\" \u001413.0\tRecruitment Methods\t\u0013 PAGEREF _Toc496162141 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162142\" \u001414.0\tWithdrawal of Subjects*\t\u0013 PAGEREF _Toc496162142 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162143\" \u001415.0\tRisks to Subjects*\t\u0013 PAGEREF _Toc496162143 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162144\" \u001416.0\tPotential Benefits to Subjects*\t\u0013 PAGEREF _Toc496162144 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162145\" \u001417.0\tData Management* and Confidentiality\t\u0013 PAGEREF _Toc496162145 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc496162146\" \u001418.0\tProvisions to Monitor the Data to Ensu","cbCaioDZtBy63q3Y","https://ap.wps.com/l/cbCaioDZtBy63q3Y","docx",56108,"English","# 1.0 Study Summary\n## 2.0 Objectives*\n## 3.0 Background*\n## 4.0 Study Endpoints*\n## 5.0 Study Intervention/Investigational Agent\n## 6.0 Procedures Involved*\n## 7.0 Data and Specimen Banking*\n## 8.0 Sharing of Results with Subjects*\n## 9.0 Study Timelines*\n## 10.0 Inclusion and Exclusion Criteria*\n## 11.0 Vulnerable Populations*","[{\"question\":\"How should study endpoints and interventions be described?\",\"answer\":\"Describe primary and secondary study endpoints. Provide a clear description of the study intervention being evaluated, then explain the study design and procedures, including safety monitoring and timing of procedures.\"}]","TEMPLATE SBS PROTOCOL (HRP-503(SBS)) - Study Summary | DOCX",1788295555,6]