[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-163675-105":53,"doc-detail-163675-en":127},{"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":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","hrp-508-templatesitesupplementtosponsorprotocol-local-study-site-information","HRP-508-TEMPLATESiteSupplementtoSponsorProtocol - Local Study Site Information","","A site supplement template for local study sites when a main study protocol is provided by a sponsor or when a non-standard protocol template is used that does not include all elements of required VCU protocol templates. Provides instructions to retain section headings, mark inapplicable sections as “NA,” and reference the main protocol with section/page numbers when content is already covered. Requires attaching the full sponsor protocol, using Track Changes for revisions, and following obligations when relying on an external IRB. Includes structured sections for study summary, intervention handling, and data/specimen banking.",{"@graph":63,"@context":119},[64,80,102],{"@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":41,"@type":70,"position":76},"https://docshare.wps.com/template/letters/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/hrp-508-templatesitesupplementtosponsorprotocol-local-study-site-information/163675/",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/hrp-508-templatesitesupplementtosponsorprotocol-local-study-site-information/163675.png","ImageObject",442,249,{"name":88,"@type":89},"WPS_1786070896","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-01","2026-08-31",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",7,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"When should a site supplement template be used instead of the main study protocol?","Question",{"text":109,"@type":110},"Use it when the sponsor provides the main protocol for the study or when the researcher must use another non-standard protocol template that lacks all VCU template elements.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"What should be done for sections that are not applicable to the research?",{"text":114,"@type":110},"Mark those sections as “NA” and do not delete the section headings.",{"name":116,"@type":107,"acceptedAnswer":117},"How should the site supplement handle information already fully covered in the main protocol?",{"text":118,"@type":110},"Note the relevant main protocol section number and page number, and ensure the team evaluates whether sufficient local detail is included for the Human Research Protection Program.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},163675,1790034208,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":40,"category_name":41,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":8,"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":140,"read_time":79},549768072016,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","PROTOCOL TITLE: Click or tap here to enter text.\nINSTRUCTIONS:\nUse this template to provide local study site information when the main study protocol is provided by a study sponsor (e.g., for an industry-sponsored drug study), or when the researcher must use another non-standard protocol template that does not include all of the elements of the VCU template protocols (HRP-503-TEMPLATE PROTOCOL or HRP-503a-TEMPLATE SBS PROTOCOL).\nDepending on the nature of your study, some sections may not be applicable to your research. These should be marked with “NA”.  Do not delete section headings.\nFor any requested information below that is already fully addressed in the main protocol, simply note the section number/page number of the main protocol.  When doing so, note that it is important for the study team to evaluate whether the main protocol section includes sufficient local detail requested in this Site Supplement.  It is not sufficient to simply say “see protocol” in the Site Supplement as this does not provide sufficient detail to the Human Research Protection Program.\nAttach the entire sponsor’s protocol. Unless otherwise specified, provide only site-specific information below.\nWhen you write a single site supplement, keep an electronic copy. You will need to modify this copy when making changes. When you make changes, use the Track Changes feature.\nWhen relying on an external IRB, changes must be submitted to the Site Supplement and submitted in the RAMS-IRB reliance application in accordance with HRP-103 Investigator Manual (see “What are my obligations as investigator when relying on an external IRB?”).\nPROTOCOL TITLE:\nInclude the full protocol title. Click or tap here to enter text.\nPRINCIPAL INVESTIGATOR:\nName Click or tap here to enter text.\nDepartment Click or tap here to enter text.\nTelephone Number Click or tap here to enter text.\nEmail Address Click or tap here to enter text.\nVERSION NUMBER/DATE:\nInclude the version number and date of this site supplement. Click or tap here to enter text.\nRevision History\nTable of Contents\n\u0003\u0013 TOC \\h \\u \\z \\t \"Heading 1,1,Heading 2,2,Heading 3,3,\"\u0014\u0013 HYPERLINK \\l \"_heading=h.4i7ojhp\" \\h \u00141.0\u0015\u0013 HYPERLINK \\l \"_heading=h.4i7ojhp\" \\h \u0014\t\u0015\u0013 PAGEREF _heading=h.4i7ojhp \\h \u0014Study Summary\t3\u0015\n\u0013 HYPERLINK \\l \"_heading=h.2xcytpi\" \\h \u00142.0\u0015\u0013 HYPERLINK \\l \"_heading=h.2xcytpi\" \\h \u0014\t\u0015\u0013 PAGEREF _heading=h.2xcytpi \\h \u0014Study Intervention/Investigational Agent\t3\u0015\n\u0013 HYPERLINK \\l \"_heading=h.1ci93xb\" \\h \u00143.0\u0015\u0013 HYPERLINK \\l \"_heading=h.1ci93xb\" \\h \u0014\t\u0015\u0013 PAGEREF _heading=h.1ci93xb \\h \u0014Data and Specimen Banking\t4\u0015\n\u0013 HYPERLINK \\l \"_heading=h.3whwml4\" \\h \u00144.0\u0015\u0013 HYPERLINK \\l \"_heading=h.3whwml4\" \\h \u0014\t\u0015\u0013 PAGEREF _heading=h.3whwml4 \\h \u0014Sharing of Results with Subjects\t4\u0015\n\u0013 HYPERLINK \\l \"_heading=h.2bn6wsx\" \\h \u00145.0\u0015\u0013 HYPERLINK \\l \"_heading=h.2bn6wsx\" \\h \u0014\t\u0015\u0013 PAGEREF _heading=h.2bn6wsx \\h \u0014Inclusion and Exclusion Criteria\t4\u0015\n\u0013 HYPERLINK \\l \"_heading=h.qsh70q\" \\h \u00146.0\u0015\u0013 HYPERLINK \\l \"_heading=h.qsh70q\" \\h \u0014\t\u0015\u0013 PAGEREF _heading=h.qsh70q \\h \u0014Vulnerable Populations\t4\u0015\n\u0013 HYPERLINK \\l \"_heading=h.3as4poj\" \\h \u00147.0\u0015\u0013 HYPERLINK \\l \"_heading=h.3as4poj\" \\h \u0014\t\u0015\u0013 PAGEREF _heading=h.3as4poj \\h \u0014Local Number of Subjects\t5\u0015\n\u0013 HYPERLINK \\l \"_heading=h.1pxezwc\" \\h \u00148.0\u0015\u0013 HYPERLINK \\l \"_heading=h.1pxezwc\" \\h \u0014\t\u0015\u0013 PAGEREF _heading=h.1pxezwc \\h \u0014Local Recruitment Methods\t5\u0015\n\u0013 HYPERLINK \\l \"_heading=h.49x2ik5\" \\h \u00149.0\u0015\u0013 HYPERLINK \\l \"_heading=h.49x2ik5\" \\h \u0014\t\u0015\u0013 PAGEREF _heading=h.49x2ik5 \\h \u0014Withdrawal of Subjects\t6\u0015\n\u0013 HYPERLINK \\l \"_heading=h.2p2csry\" \\h \u001410.0\u0015\u0013 HYPERLINK \\l \"_heading=h.2p2csry\" \\h \u0014\t\u0015\u0013 PAGEREF _heading=h.2p2csry \\h \u0014Data Management and Confidentiality\t6\u0015\n\u0013 HYPERLINK \\l \"_heading=h.147n2zr\" \\h \u001411.0\u0015\u0013 HYPERLINK \\l \"_heading=h.147n2zr\" \\h \u0014\t\u0015\u0013 PAGEREF _heading=h.147n2zr \\h \u0014Provisions to Protect the Privacy Interests of Subjects\t6\u0015\n\u0013 HYPERLINK \\l \"_heading=h.3o7alnk\" \\h \u001412.0\u0015\u0013 HYPERLINK \\l \"_heading=h.3o7alnk\" \\h \u0014\t\u0015\u0013 PAGEREF _heading=h.3o7alnk \\h \u0014Compensation for Research-Related Injury\t7\u0015\n\u0013 HYPERLINK \\l \"_heading=h.23ckvvd\"","cbCaibGDVijHfixJ","https://ap.wps.com/l/cbCaibGDVijHfixJ","docx",104527,"English","# Study Summary\n## Study Intervention/Investigational Agent\n## Data and Specimen Banking","[{\"question\":\"When should a site supplement template be used instead of the main study protocol?\",\"answer\":\"Use it when the sponsor provides the main protocol for the study or when the researcher must use another non-standard protocol template that lacks all VCU template elements.\"},{\"question\":\"What should be done for sections that are not applicable to the research?\",\"answer\":\"Mark those sections as “NA” and do not delete the section headings.\"},{\"question\":\"How should the site supplement handle information already fully covered in the main protocol?\",\"answer\":\"Note the relevant main protocol section number and page number, and ensure the team evaluates whether sufficient local detail is included for the Human Research Protection Program.\"}]","HRP-508-TEMPLATESiteSupplementtoSponsorProtocol - Local Study Site Information | DOCX",1788146180]