[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-241588-en":3,"detail-sidebar-cat-1-en-105":31,"doc-seo-241588-105":76},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":21,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":22,"language":23,"language_code":24,"site_id":25,"html_lang":24,"table_of_contents":26,"faqs":27,"seo_title":28,"seo_description":15,"update_tm":29,"read_time":30},241588,549768072016,"WPS_1786070896","https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d",1,17,"Forms","REAL-WORLD TREATMENT AND OUTCOME PATTERNS IN R/RDLBCL PATIENTS IN THIRD LINE AND BEYOND: A DANISH POPULATION-BASED STUDY - Research Plan - Version 4.0","Research plan for an RWE scientific project evaluating real-world treatment and outcome patterns in patients with refractory or relapsed DLBCL (R/RDLBCL) in third line and beyond using a Danish population-based approach. The document specifies project identifier SG43837, version and template basis, outlines milestones for dataset creation through publication submission, and defines research questions, objectives, methods, data sources, variables, endpoints, statistical considerations, documentation, and study limitations. It also covers human protection, consent and regulatory compliance, and plans for dissemination and adverse event management.","Based on Research Plan template Version 4.0 released on 26 Feb 2021  \nRESEARCH PLAN (RWE SCIENTIFIC PROJECT)  \n\n| TITLE: | REAL-WORLD TREATMENT AND OUTCOME PATTERNS IN R/RDLBCL PATIENTS IN THIRD LINE AND BEYOND: A DANISH POPULATION-BASED STUDY |\n| --- | --- |\n| PROJECT NUMBER: | SG43837 |\n| VERSION NUMBER: | 1.0 |\n| STUDIED MEDICINAL PRODUCT: | None |\n| RESEARCH INITIATOR: | Ashwini Shewade\u003Cbr>Genentech, Inc (a member of Roche)\u003Cbr>1 DNA Way, South San Francisco\u003Cbr>CA 94080 |\n| AUTHOR: | Thomas Stauffer Larsen MD PhD Department of Hematology Odense University of Hospital 5000 Odense C Denmark\u003Cbr>[thomas.stauffer.larsen@rsyd.dk](thomas.stauffer.larsen@rsyd.dk)\u003Cbr>Ashwini Shewade\u003Cbr>Principal Data Scientist, RWD Enabling Platform PD Data Sciences\u003Cbr>Genentech, a member of Roche\u003Cbr>[shewadea@gene.com](shewadea@gene.com) |\n| DATE FINAL: | See electronic date stamp below |\n\nDate and Time (UTC)  \n21-Dec-2021 17:39:02  \nTitle  \nCMD  \nApprover's Name  \nFlahavan, Eva (flahavae)  \nBased on research plan template Version 4.0 released on 26 Feb 2021  \nTABLE OF CONTENTS  \n1. LIST OF ABBREVIATIONS 3  \n2. RESEARCH TEAM 5  \n3. AMENDMENTS AND UPDATES 6  \n4. Milestones 7  \n5. Research Question and Objectives 8  \n6. Research methods 9  \n6.1 Data Source(s) 9  \n6.2 Setting 9  \n6.3 Variables and Endpoints 10  \n6.3.1 Study Variables 10  \n6.3.2 Endpoints 11  \n6.4 Research Size 11  \n6.5 Data Management 11  \n6.5.1 Data Quality Assurance 12  \n6.6 Data Analysis and other statistical considerations 12  \n6.7 Research Documentation 12  \n6.8 Limitations of the research method 13  \n7. Protection of human patients 13  \n7.1 Informed Consent 13  \n7.2 Compliance with Laws and Regulations 13  \n7.3 Institutional Review Board or Ethics Committee 14  \n8. PLANS FOR DISSEMINATION AND COMMUNICATION OF RESEARCH RESULTS 14  \n9. Management and Reporting of Adverse Events 14  \n10. Retention of Records 14  \n11. References 15  \nAppendix 1 REDCap eCRF 17  \nF. Hoffmann-La Roche Ltd  \nResearch Plan SG43837, Version 1.0  \nBased on Research Plan template Version 4.0 released on 26 Feb 2021  \n1.  LIST OF ABBREVIATIONS  \n\n| Abbreviation Definition |  |\n| --- | --- |\n| ALAT\u003Cbr>ASCT\u003Cbr>C\u003Cbr>CAR\u003Cbr>CHOEP\u003Cbr>CNS\u003Cbr>COO\u003Cbr>CR\u003Cbr>CRP\u003Cbr>CSF\u003Cbr>CT\u003Cbr>DA-EPOCH\u003Cbr>DLBCL\u003Cbr>EC\u003Cbr>ECOG\u003Cbr>eCRF\u003Cbr>eGFR\u003Cbr>FDA\u003Cbr>FISH\u003Cbr>GPP\u003Cbr>H\u003Cbr>HGBCL\u003Cbr>IPI\u003Cbr>IRB\u003Cbr>LDH\u003Cbr>LVEF\u003Cbr>LYFO\u003Cbr>mAB\u003Cbr>MAIC\u003Cbr>NHL\u003Cbr>NOS\u003Cbr>NYHA\u003Cbr>O | Alanin aminotransferase Autologous stem cell transplantation Cyclophosphamide\u003Cbr>Chimeric antigen receptor\u003Cbr>Cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone\u003Cbr>Central nervous system Cell of origin Complete response\u003Cbr>c-reactive protein Cerebrospinal fluid Computed tomography\u003Cbr>Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin\u003Cbr>Diffuse large B-cell lymphoma Ethics Committee\u003Cbr>Eastern Cooperative Oncology Society Electronic case report form Estimated glomerular filtration rate Food and Drug Administration Florescence in situ hybridization\u003Cbr>Good Pharmacoepidemiological Practice Doxorubicin\u003Cbr>High grade B-cell lymphoma International prognostic index Institutional Review Board\u003Cbr>Lactate dehydrogenase\u003Cbr>Left ventricular ejection fraction The Danish National Lymphoma Registry Monoclonal antibody\u003Cbr>Matching-adjusted indirect comparison Non-Hodgkin’s Lymphoma Not otherwise specified\u003Cbr>New York Heart Association Vincristine |\n\nF. Hoffmann-La Roche Ltd  \nResearch Plan SG43837, Version 1.0  \nBased on research plan template Version 4.0 released on 26 Feb 2021  \n\n| Abbreviation | Definition |\n| --- | --- |\n| ORR | Overall response rate |\n| OS | Overall survival |\n| P | Prednisone |\n| PD | Progressive disease |\n| PET/CT | Positron emission tomography and computed tomography |\n| PFS | Progression-free survival |\n| PI | Principle investigator |\n| PMBCL | Primary mediastinal B-cell lymphoma |\n| R | Rituximab |\n| R-CHOP | Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone |\n| R/R | Refractory or relapsed |\n| SCT | Stem cell t","cbCairMmgKZQEZOg","https://ap.wps.com/l/cbCairMmgKZQEZOg","pdf",1116099,2,65,"English","en",105,"# Table of Contents\n## List of abbreviations\n## Research team\n## Amendments and updates\n## Milestones\n## Research question and objectives\n## Research methods\n## Protection of human patients\n## Plans for dissemination and communication of research results\n## Management and reporting of adverse events\n## Retention of records\n## References\n## Appendix 1 REDCap eCRF","[{\"question\":\"What study population and setting are targeted in this research plan?\",\"answer\":\"Patients with refractory or relapsed DLBCL in third line and beyond are studied using a Danish population-based approach.\"},{\"question\":\"What is the project number and version referenced in the plan?\",\"answer\":\"The project number is SG43837 and the document is labeled Research Plan SG43837, Version 1.0, based on the template Version 4.0 released on 26 Feb 2021.\"},{\"question\":\"Which major research topics are covered beyond methods?\",\"answer\":\"The plan includes milestones, research questions and objectives, protection of human patients (consent and regulatory compliance), dissemination and communication, adverse event management, retention of records, and references, plus an appendix for REDCap eCRF.\"}]","REAL-WORLD TREATMENT AND OUTCOME PATTERNS IN R/RDLBCL PATIENTS IN THIRD LINE AND BEYOND: A DANISH POPULATION-BASED STUDY - 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