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It defines responsibilities for study teams, including user training, role-permission assignment, user account lifecycle management, access-date control, and periodic review of authorization. It also specifies scope limitations, including exclusion of legacy studies and records containing Protected Health Information maintained under separate SOPs.",{"@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/customer-name-template-use-of-florence-ebinders-v60/172782/",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/customer-name-template-use-of-florence-ebinders-v60/172782.png","ImageObject",442,249,{"name":88,"@type":89},"Himbo","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-21","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":15},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the purpose of this SOP for Florence eBinders?","Question",{"text":108,"@type":109},"The SOP describes identification and storage of regulatory Essential Documents in Florence and defines the process for delegating roles and responsibilities to appropriate personnel.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What does the SOP cover and not cover?",{"text":113,"@type":109},"It applies to electronic records from planning and study startup through completion/archival for studies using Florence eTMF/eISF. It excludes legacy studies and certain Essential Documents and records with Protected Health Information, which follow other SOPs.",{"name":115,"@type":106,"acceptedAnswer":116},"What responsibilities are assigned regarding user access in Florence?",{"text":117,"@type":109},"The designated individual or designee ensures new users are trained before access, assigns role permissions for study tasks, manages user account creation/modification/termination, removes permissions upon employment status changes, and turns off access for temporarily inactive users.","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},172782,1791212950,{"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":15,"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":140,"read_time":76},687197100911,"https://ap-avatar.wpscdn.com/avatar/a000239b6f1da00475?x-image-process=image/resize,m_fixed,w_180,h_180&k=1785132997149421697","Template Standard Operating Procedure:\nUse of Florence for Electronic Records and Electronic Signatures\nFlorence Template V6.0 11MAR2024\nTable of Contents\n\u0003\u0013 TOC \\h \\u \\z \\t \"Heading 1,1,Heading 2,2,Heading 3,3,Heading 4,4,Heading 5,5,Heading 6,6,\"\u0014\u0013 HYPERLINK \\l \"_heading=h.gjdgxs\" \\h \u0014Purpose\u0015\t\u0013 PAGEREF _heading=h.gjdgxs \\h \u00142\u0015\n\u0013 HYPERLINK \\l \"_heading=h.30j0zll\" \\h \u0014Scope\u0015\t\u0013 PAGEREF _heading=h.30j0zll \\h \u00142\u0015\n\u0013 HYPERLINK \\l \"_heading=h.1fob9te\" \\h \u0014Responsibilities\u0015\t\u0013 PAGEREF _heading=h.1fob9te \\h \u00143\u0015\n\u0013 HYPERLINK \\l \"_heading=h.3znysh7\" \\h \u0014Site Personnel Training\u0015\t\u0013 PAGEREF _heading=h.3znysh7 \\h \u00144\u0015\n\u0013 HYPERLINK \\l \"_heading=h.tyjcwt\" \\h \u0014Policies & Procedures –Electronic Document Management\u0015\t\u0013 PAGEREF _heading=h.tyjcwt \\h \u00145\u0015\n\u0013 HYPERLINK \\l \"_heading=h.3dy6vkm\" \\h \u0014Policies & Procedures – Electronic Signatures\u0015\t\u0013 PAGEREF _heading=h.3dy6vkm \\h \u00146\u0015\n\u0013 HYPERLINK \\l \"_heading=h.1t3h5sf\" \\h \u0014Policies & Procedures – Signature Logs\u0015\t\u0013 PAGEREF _heading=h.1t3h5sf \\h \u00147\u0015\n\u0013 HYPERLINK \\l \"_heading=h.4d34og8\" \\h \u0014References\u0015\t\u0013 PAGEREF _heading=h.4d34og8 \\h \u00148\u0015\u0015\u0004\nPurpose\nFederal regulations require documentation of all study-related activities. Investigators are responsible for maintaining study documents in accordance with applicable federal regulations, International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines, customer to specify any relevant privacy laws (e.g. Health Insurance Portability and Accountability Act of 1996 (HIPAA) requirements,  California Consumer Privacy Act (CCPA) or General Data Protection Regulation (GDPR)), and departmental procedures.\nAt all times, study documents must be readily accessible for review and/or inspection by the regulatory agency (i.e., [Insert: US Food and Drug Administration (FDA) or any other applicable regulatory agencies you will be submitting to]), approving Institutional Review Board (IRB), and/or organizational personnel as appropriate.\nThis Standard Operating Procedure (SOP) describes the identification and storage of regulatory Essential Documents for clinical research studies and trials in Florence [eTMF/eISF: Customer to Specify]  and establishes the process by which roles and  responsibilities are delegated to applicable personnel.\nScope\nThis SOP applies to all electronic records for the clinical research studies and trials where Florence [eTMF/eISF: Customer to Specify] is utilized by [customer to specify  organization].\nThis SOP applies to personnel engaged in the collection, creation, retrieval, modification,  maintenance, transmittal and/or storage of Essential Documents from the planning and study startup stage through study completion/archival. This SOP does not apply to legacy studies.\nLegacy studies are defined as studies [Customer to DEFINE: where the Clinical Trial Agreement (CTA) was signed prior to the go live date with Florence; or that were activated prior to the use of Florence.] Legacy documents will be: select the appropriate option from below based on whether documents will be imported or not\nImported: Legacy documents will be maintained following the organization’s current Essential Documents SOP (reference: SOP-XYZ) until the time period when they can be imported, verified for completeness and signed as certified copies. As time permits, legacy documents will be uploaded into Florence at which point it will comply with this SOP. OR\nNot imported: Legacy documents will be maintained following the organization’s current Essential Documents SOP [Insert: SOP ID].\nThis SOP excludes the following Essential Documents which will be maintained following the organization's current SOP (reference: SOP-XYZ):\n[List applicable documents here – e.g., original wet-ink signed contracts]\nThis SOP excludes the following records with Protected Health Information (PHI), which will be maintained following the organization's current SOP (reference: SOP-XYZ):\n[List applicable documents here – e.g., clinic EMR records, eConsent forms]\nResponsibilities\nThe [ Custome","cbCailzk8yZIB3c9","https://ap.wps.com/l/cbCailzk8yZIB3c9","docx",344042,9,"English","# Purpose\n## Scope\n## Responsibilities\n## Site Personnel Training\n## Policies & Procedures –Electronic Document Management\n## Policies & Procedures – Electronic Signatures\n## Policies & Procedures – Signature Logs\n## References","[{\"question\":\"What is the purpose of this SOP for Florence eBinders?\",\"answer\":\"The SOP describes identification and storage of regulatory Essential Documents in Florence and defines the process for delegating roles and responsibilities to appropriate personnel.\"},{\"question\":\"What does the SOP cover and not cover?\",\"answer\":\"It applies to electronic records from planning and study startup through completion/archival for studies using Florence eTMF/eISF. It excludes legacy studies and certain Essential Documents and records with Protected Health Information, which follow other SOPs.\"},{\"question\":\"What responsibilities are assigned regarding user access in Florence?\",\"answer\":\"The designated individual or designee ensures new users are trained before access, assigns role permissions for study tasks, manages user account creation/modification/termination, removes permissions upon employment status changes, and turns off access for temporarily inactive users.\"}]","Customer-Name-TEMPLATE-Use-of-Florence-eBinders - V6.0 | DOCX",1788296653]