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Specifies the required content, structure, and presentation format using the company evidence submission template, including limitations on submission length and requirements for stand-alone electronic Word-compatible submission (not PDF). Outlines confidentiality handling, inclusion and consistency of an executable economic model with full programming code, completion of NICE-provided confidential information checklists, and supports transparent, publicly shareable evidence. 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The submission must be a stand-alone document, with any required appendices clearly marked.",{"name":115,"@type":106,"acceptedAnswer":116},"What conditions must companies meet regarding confidential information and the economic model?",{"text":117,"@type":109},"Confidential information must be highlighted and underlined in the electronic version sent to NICE. Companies must include an executable electronic copy of the economic model with full access to programming code, and ensure the evidence submission content matches the economic model content.","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},166762,1790161805,{"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":73,"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":141},549768064778,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","Single technology appraisal: User guide for company evidence submission template\nJanuary 2015\nApril 2017\nInstructions for companies\nThis is the user guide for submission of evidence to the National Institute for Health and Care Excellence (NICE) as part of the single technology appraisal (STA) process. It explains what information NICE requires and the format in which it should be presented.\nInformation should be submitted in the \u0013 HYPERLINK \"https://www.nice.org.uk/About/What-we-do/Our-Programmes/NICE-guidance/NICE-technology-appraisal-guidance\" \u0014company evidence submission template\u0015. Companies making evidence submissions to NICE should also refer to the NICE \u0013 HYPERLINK \"https://www.nice.org.uk/process/pmg9/chapter/introduction\" \u0014guide to the methods of technology appraisal\u0015, particularly section 5 (the reference case). The NICE \u0013 HYPERLINK \"https://www.nice.org.uk/process/pmg19/chapter/introduction\" \u0014guide to the processes of technology appraisal\u0015 gives further details of procedures relating to STA submissions.\nThe submission should be as brief and informative as possible. The main body of the submission must not be longer than 150 pages, excluding the appendices and the pages covered by the template.\nThe submission should be sent to NICE electronically in Word or a compatible format, and not as a PDF file. The submission must be a stand-alone document. Some of the information we request should be submitted as appendices to the main submission (when this is the case, it is clearly marked). The information in these appendices is required by the evidence review group (ERG) to fully critique the submission. The appendices are not normally presented to the appraisal committee, but will be available to them on request.\nWhen making an evidence submission, companies must ensure that:\nAll confidential information is highlighted and underlined in the electronic version sent to NICE.\nAn executable electronic copy of the economic model is included in the version sent to NICE, with full access to the programming code. The content of the evidence submission and the content of the economic model should match.\nThe checklist of confidential information (provided by NICE with the invitation to submit) is completed and submitted.\nSee section 3 of the NICE \u0013 HYPERLINK \"https://www.nice.org.uk/process/pmg19/chapter/the-appraisal-process\" \u0014guide to the processes of technology appraisal\u0015 for information about all aspects of information handling.\nTo ensure that the appraisal process is as transparent as possible, NICE considers that evidence on which the appraisal committee’s decisions are based should be publicly available.\nNICE requires the medical director of the company to sign a statement confirming that all clinical trial data necessary to address the remit and scope of the technology appraisal as issued by the Department of Health and NICE, within the company's or any of its associated companies’ possession, custody, or control in the UK, or elsewhere in the world, have been disclosed.\nNICE considers that the definition of ‘all clinical trial data’ is not limited to conventional randomised controlled trials (RCTs), but is meant to include other types of interventional or observational clinical research methodologies, such as large simple trials, cohort studies, case control studies, or registry data. This definition is consistent with that used by the European Medicines Agency in its \u0013 HYPERLINK \"http://www.ema.europa.eu/ema/?curl=pages/special_topics/general/general_content_000555.jsp\" \u0014policy on publication of clinical data on medicinal products for human use\u0015.\nNICE requires companies to consent to European Economic Area regulatory authorities directly providing NICE with all clinical trial data necessary to address the remit and scope of the technology appraisal as issued by the Department of Health and NICE. This includes all data that have been submitted to the regulatory authorities by the company or any of its associated companies a","cbCaigoux6h5TjqH","https://ap.wps.com/l/cbCaigoux6h5TjqH","docx",91635,54,"English","# Instructions for companies\n## Submission format and length limits\n## Electronic submission requirements\n## Confidentiality and checklist process\n## Economic model and consistency requirement\n## Transparency and public availability of evidence\n## Company disclosure and clinical trial data statement\n# Decision problem, technology description, and clinical pathway\n## Decision problem selection and table requirements\n## Description of the technology being appraised\n## Health condition and position in the treatment pathway\n## Equality considerations","[{\"question\":\"What is the purpose of this user guide in the STA process?\",\"answer\":\"It explains what information NICE requires from companies and the format companies should use when submitting evidence for a Single Technology Appraisal (STA).\"},{\"question\":\"How should companies submit the evidence to NICE, and what format is required?\",\"answer\":\"Submit electronically in Word or a compatible format rather than as a PDF. The submission must be a stand-alone document, with any required appendices clearly marked.\"},{\"question\":\"What conditions must companies meet regarding confidential information and the economic model?\",\"answer\":\"Confidential information must be highlighted and underlined in the electronic version sent to NICE. Companies must include an executable electronic copy of the economic model with full access to programming code, and ensure the evidence submission content matches the economic model content.\"}]","Single Technology Appraisal - Company Evidence Submission Template User Guide | DOCX",1788200635,19]