[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-detail-178030-en":53,"doc-seo-178030-105":74},{"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":5,"data":54},{"doc_id":55,"user_id":56,"nickname":57,"user_avatar":58,"doc_module":9,"category_id":50,"category_name":51,"doc_title":59,"doc_description":60,"doc_content":61,"file_id":62,"file_url":63,"file_type":64,"file_size":65,"view_count":66,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":20,"language":67,"language_code":68,"site_id":69,"html_lang":68,"table_of_contents":70,"faqs":71,"seo_title":72,"seo_description":60,"update_tm":73,"read_time":47},178030,1099514068365,"Aurelia","https://ap-avatar.wpscdn.com/avatar/10000253d8d9f28188e?_k=1776742907772140068","Data Management SOP - Purpose","Standard Operating Procedure outlining data management requirements for clinical research projects, including responsibilities across sponsor roles, chief investigator oversight, and potential delegation to clinical trials units or trial teams. Defines the SOP’s scope across University of Birmingham-sponsored studies, external sponsor studies subject to contract consistency, and projects mandated by UoB research ethics committee principles. Establishes implementation timing, stakeholder expectations, and background rationale emphasizing robust, ALCOA+ compliant data handling and reliable reporting.","Standard Operating Procedure:\ndata management\nAccess the \u0013 HYPERLINK \"https://www.birmingham.ac.uk/research/activity/mds/mds-rkto/governance/e-pathway/overview.aspx\" \\o \"Link to the Clinical Research e-Pathway\" \u0014Clinical Research e-Pathway\u0015 for a roadmap to help navigate a complete project lifecycle.\n\u0003Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc215130790\" \u0014Purpose\t\u0013 PAGEREF _Toc215130790 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130791\" \u0014Scope\t\u0013 PAGEREF _Toc215130791 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130792\" \u0014Implementation plan\t\u0013 PAGEREF _Toc215130792 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130793\" \u0014Stakeholders\t\u0013 PAGEREF _Toc215130793 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130794\" \u0014Background\t\u0013 PAGEREF _Toc215130794 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130795\" \u0014Procedure\t\u0013 PAGEREF _Toc215130795 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130796\" \u00141.\tSet-up of data management processes\t\u0013 PAGEREF _Toc215130796 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130797\" \u0014Define data management processes\t\u0013 PAGEREF _Toc215130797 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130798\" \u0014Develop data management tools\t\u0013 PAGEREF _Toc215130798 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130799\" \u0014Set up and maintain study/trial systems\t\u0013 PAGEREF _Toc215130799 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130800\" \u00142.\tData collection and processing\t\u0013 PAGEREF _Toc215130800 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130801\" \u00143.\tEnd of data collection\t\u0013 PAGEREF _Toc215130801 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130802\" \u0014List of expected outputs\t\u0013 PAGEREF _Toc215130802 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130803\" \u0014Study/trial systems\t\u0013 PAGEREF _Toc215130803 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130804\" \u0014Related documents\t\u0013 PAGEREF _Toc215130804 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130805\" \u0014Associated QMS documents\t\u0013 PAGEREF _Toc215130805 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130806\" \u0014Additional QMS documents\t\u0013 PAGEREF _Toc215130806 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130807\" \u0014References & frameworks\t\u0013 PAGEREF _Toc215130807 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130808\" \u0014Abbreviations\t\u0013 PAGEREF _Toc215130808 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130809\" \u0014Document contributors\t\u0013 PAGEREF _Toc215130809 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130810\" \u0014Document history\t\u0013 PAGEREF _Toc215130810 \\h \u001413\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130811\" \u0014Document version log\t\u0013 PAGEREF _Toc215130811 \\h \u001413\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc215130812\" \u0014Document revision log\t\u0013 PAGEREF _Toc215130812 \\h \u001413\u0015\u0015\n\u0015\u0004\n\u000f\nPurpose\nThis standard operating procedure (SOP) describes the data management procedures that need to be followed for a clinical research project.\nScope\nThis SOP applies to: (1) clinical research sponsored by the University of Birmingham (UoB); (2) clinical research sponsored by another institution, except to the extent that the SOP is inconsistent with any contract between UoB and that institution; and (3) clinical research approved by a UoB research ethics committee (REC) in circumstances where the REC requires that the clinical research conform with the UoB Principles of Good Clinical Practice (GCP) for Clinical Research (UoB-GCP-POL-001).\nWhere this SOP does not apply, the chief investigator (CI) of a clinical research project may at their discretion refer to it as a non-binding source of guidance.\nImplementation plan\nThis SOP will be implemented in line with this document’s effective date, with the exception of procedural points 1.18, 1.22 and 3.5 that will be subject to a three-month implementation period.\nStakeholders\nNote that where the UoB takes on the sponsor’s responsibility for data management, the UoB will delegate the majority of these duties to the chief investigator (CI) or to a clinical trials unit (CTU), who may delegate these duties further to their trials team(s). All delegation of duties will be documented (e.g., using the CI declaration and/or the Clinical Trials Task Delegation Log (UoB-SPO-QCD-001)).\nCI: the CI may delegate some activities to members of their research team, although evidence of CI oversight and approval is still required. 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