[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-172512-105":53,"doc-detail-172512-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","hrp-503-biomedical-protocol-template-study-summary","HRP-503 Biomedical Protocol Template - Study Summary","","Biomedical and FDA-regulated research protocol template instructions covering how to prepare a clean, editable protocol for RAMP submission. Guides include aligning the protocol title with Basic Study Information, completing principal investigator details, maintaining version number/date rules, and removing italicized guidance before finalization. Provides structure for a full protocol narrative while directing certain sections to be marked N/A when not applicable. 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It also defines how to structure required study information across standard protocol sections.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How should the protocol title and principal investigator information be completed?",{"text":113,"@type":109},"The protocol title must match section 1 of the Basic Study Information page in the RAMP application. Principal investigator details include name, department, telephone number, and email address.",{"name":115,"@type":106,"acceptedAnswer":116},"What editing steps are required before the final protocol is submitted?",{"text":117,"@type":109},"Keep an electronic clean copy with all changes accepted and comments deleted. Remove all italicized instructions so they do not appear in the final version, and mark non-applicable sections as “N/A” without deleting section numbers.","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},172512,1790014038,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":15,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":25,"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":47},8796095027276,"https://avatar.qwps.com/avatar/d3BzX2FwX3Rlc3RfMjUxMTI2XzAxODA=","INSTRUCTIONS:\nThis protocol template is intended for use with Biomedical and FDA-regulated studies\nUse HRP-503a - TEMPLATE SBS PROTOCOL to prepare a document with the information from the following sections.\nWhen you write a protocol, keep an electronic, clean (all changes accepted, all comments deleted) copy. You will need to modify this copy when making changes.\nAll referenced checklists, templates, policies, and manuals can be found in the RAMP Library and on the IRB website.\nAs you are writing the protocol, remove all instructions in italics so that they are not contained in the final version of your protocol. Depending on the nature of your study, some sections may not be applicable to your research. If so mark as “N/A”. Do not delete the section numbers.\nFor submission of a protocol specific to a participating Site as part of a Multi-Site Study, use HRP-508 – TEMPLATE - SITE SUPPLEMENT\nPROTOCOL TITLE:\nInclude the full protocol title. This title should match section 1 of the Basic Study Information page of the RAMP application.\nPRINCIPAL INVESTIGATOR:\nName\nDepartment\nTelephone Number\nEmail Address\nVERSION NUMBER/DATE:\nInclude the version number and date of this protocol.\n*The version number should remain unchanged during pre-review until initial approval. The version date can be updated to reflect changes that are made.\nREVISION HISTORY\n\u000f\nTable of Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc150240682\" \u00141.0\tStudy Summary\t\u0013 PAGEREF _Toc150240682 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240683\" \u00142.0\tObjectives\t\u0013 PAGEREF _Toc150240683 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240684\" \u00143.0\tBackground\t\u0013 PAGEREF _Toc150240684 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240685\" \u00144.0\tStudy Endpoints\t\u0013 PAGEREF _Toc150240685 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240686\" \u00145.0\tStudy Intervention/Investigational Agent\t\u0013 PAGEREF _Toc150240686 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240687\" \u00146.0\tProcedures Involved\t\u0013 PAGEREF _Toc150240687 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240688\" \u00147.0\tData and Specimen Banking\t\u0013 PAGEREF _Toc150240688 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240689\" \u00148.0\tSharing of Results with Subjects\t\u0013 PAGEREF _Toc150240689 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240690\" \u00149.0\tStudy Timelines\t\u0013 PAGEREF _Toc150240690 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240691\" \u001410.0\tInclusion and Exclusion Criteria\t\u0013 PAGEREF _Toc150240691 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240692\" \u001411.0\tVulnerable Populations\t\u0013 PAGEREF _Toc150240692 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240693\" \u001412.0\tLocal Number of Subjects\t\u0013 PAGEREF _Toc150240693 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240694\" \u001413.0\tRecruitment Methods\t\u0013 PAGEREF _Toc150240694 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240695\" \u001414.0\tWithdrawal of Subjects\t\u0013 PAGEREF _Toc150240695 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240696\" \u001415.0\tRisks to Subjects\t\u0013 PAGEREF _Toc150240696 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240697\" \u001416.0\tPotential Benefits to Subjects\t\u0013 PAGEREF _Toc150240697 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240698\" \u001417.0\tData Management and Confidentiality\t\u0013 PAGEREF _Toc150240698 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240699\" \u001418.0\tProvisions to Monitor the Data to Ensure the Safety of Subjects\t\u0013 PAGEREF _Toc150240699 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240700\" \u001419.0\tProvisions to Protect the Privacy Interests of Subjects\t\u0013 PAGEREF _Toc150240700 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240701\" \u001420.0\tCompensation for Research-Related Injury\t\u0013 PAGEREF _Toc150240701 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240702\" \u001421.0\tEconomic Burden to Subjects\t\u0013 PAGEREF _Toc150240702 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240703\" \u001422.0\tConsent Process\t\u0013 PAGEREF _Toc150240703 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240704\" \u001423.0\tProcess to Document Consent in Writing\t\u0013 PAGEREF _Toc150240704 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240705\" \u001424.0\tSetting\t\u0013 PAGEREF _Toc150240705 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240706\" \u001425.0\tResources Available\t\u0013 PAGEREF _Toc150240706 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc150240707\" \u001426.0\tMulti-Site Research\t\u0013 PAGEREF _Toc150240707 \\h \u001412\u0015\u0015\n\u0015\n\u000f\nStudy Summary\nPlease provide a brief summary of the study in the table below. A complete description of the s","cbCaijirhKFnF68e","https://ap.wps.com/l/cbCaijirhKFnF68e","docx",77070,"English","# Study Summary\n## Objectives\n## Background\n## Study Endpoints\n## Study Intervention/Investigational Agent\n## Procedures Involved\n## Data and Specimen Banking\n## Sharing of Results with Subjects\n## Study Timelines\n## Inclusion and Exclusion Criteria\n## Vulnerable Populations\n## Local Number of Subjects\n## Recruitment Methods\n## Withdrawal of Subjects\n## Risks to Subjects\n## Potential Benefits to Subjects\n## Data Management and Confidentiality\n## Provisions to Monitor Data Safety\n## Provisions to Protect Privacy Interests\n## Compensation for Research-Related Injury\n## Economic Burden to Subjects\n## Consent Process\n## Process to Document Consent in Writing\n## Setting\n## Resources Available\n## Multi-Site Research","[{\"question\":\"What is the purpose of this Biomedical and FDA-regulated protocol template?\",\"answer\":\"It provides instructions for preparing a protocol document for use with Biomedical and FDA-regulated studies and for submission via the RAMP system. It also defines how to structure required study information across standard protocol sections.\"},{\"question\":\"How should the protocol title and principal investigator information be completed?\",\"answer\":\"The protocol title must match section 1 of the Basic Study Information page in the RAMP application. Principal investigator details include name, department, telephone number, and email address.\"},{\"question\":\"What editing steps are required before the final protocol is submitted?\",\"answer\":\"Keep an electronic clean copy with all changes accepted and comments deleted. Remove all italicized instructions so they do not appear in the final version, and mark non-applicable sections as “N/A” without deleting section numbers.\"}]","HRP-503 Biomedical Protocol Template - Study Summary | DOCX",1788294002]